COVID-19 Treatments

COVID-19 Disease Treatments

As of May 28, 2020,  the U.S. Food and Drug Administration (FDA) had not fully approved any medication for treating people infected with the novel coronavirus SARS-CoV-2, which causes COVID-19 disease in humans. However, the FDA issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

The FDA's Center for Drug Evaluation and Research is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from the acceleration of development for treatments for COVID-19, maintaining and securing drug supply chains, providing guidance to manufacturers, advising developers on how to handle clinical trial issues, and keeping the public informed.

The U.S. Department of HHS announced the allocation plan for the drug remdesivir on May 9, 2020. The donated doses by Gilead Sciences, Inc., which received an Emergency Use Authorization (EUA) from the U.S. FDA, will be used to treat hospitalized COVID-19 disease patients in areas of the country hardest hit by the pandemic.

Gilead previously committed to supplying approximately 607,000 vials of remdesivir over the next 6-weeks to treat an estimated 78,000 hospitalized COVID-19 patients under the EUA granted by the FDA. 

COVID-19 Treatments Highlighted in the Media (Off-Label)

  • Late-stage COVID-19patients:
    • Remdesivir (GS-5734) is an investigational nucleotide analog with broad-spectrum antiviral activity – it is being evaluated in late-stage clinical trials, but is not approved anywhere, for any use.
  • Early-stage COVID-19 patients:
    • Avigan (favipiravir) antiviral was approved in 2014 and is supplied only at the discretion of Japan’s Health, Labor, and Welfare Ministry. Avigan is not approved for distribution in the USA.
    • The U.S. FDA issued Authorization to permit the emergency use of Plaquenil to treat pre-hospitalized patients with COVID-19 disease.

May COVID-19 Disease Treatment News

  • May 2020 - Roche announced the initiation of a global phase III, randomized, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra, plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc. 

  • May 25, 2020 - Algernon Pharmaceuticals Inc. announced that it has submitted an Investigational New Drug application with the U.S. FDA for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120 (Ifenprodil), an NMDA receptor antagonist, 20 mg tablets, as a potential therapeutic treatment for patients with COVID-19 disease.

  • May 23, 2020 - The data and safety monitoring board for the phase 3 Clinical Trial NCT04280705, recommended early unblinding of the results on the basis of findings from an analysis that showed a shortened time to recovery in the remdesivir group.

  • May 22, 2020 - The Indian Council of Medical Research, the country of India’s apex body in the field, has found that consuming the drug hydroxychloroquine reduces the chances of getting infected with Covid-19 disease.

  • May 22, 2020 - Cuba credits two drugs with slashing coronavirus death toll. One is itolizumab, a monoclonal antibody produced in Cuba and elsewhere. The other is a peptide that Cuba says its biotech industry discovered and has been testing for rheumatoid arthritis in Phase II clinical trials.

  • May 22, 2020 - Fujifilm Corp. said it is on course to supply the anti-influenza drug Avigan for 2 million COVID-19 patients by March 2021.

  • May 21, 2020 – CalciMedica Inc. announced that it has received guidance from the U.S. FDA regarding the Company’s ongoing study of Auxora™ (formerly called CM4620-IE) in patients with COVID-19 pneumonia.

  • May 20, 2020 - Aldeyra Therapeutics, Inc. announced the planned advancement of the investigational new HSP90 inhibitor ADX-1612 to clinical testing for COVID-19 disease and provided an update on ADX-629, a novel investigational RASP inhibitor in development for COVID-19 and other inflammatory diseases.

  • May 20, 2020 - Atea announced the U.S. FDA had given the go-ahead for its investigational new drug (IND) application for AT-527 for adults hospitalized with moderate COVID-19. AT-527 is a novel, oral, purine nucleotide prodrug, a direct-acting antiviral that inhibits the RNA polymerase enzyme. The Phase II trial is scheduled to begin soon.

  • May 20, 2020 - BioSig Technologies, Inc. and its subsidiary, ViralClear Pharmaceuticals, Inc., announced the closing of a $10.8 million common stock financing. ViralClear plans to use the proceeds of this offering for the development, including phase II human clinical trials, of its product candidate merimepodib, a broad-spectrum antiviral agent.

  • May 19, 2020 - Innovation Pharmaceuticals announced today that its anti-SARS-CoV-2 (COVID-19) drug candidate, Brilacidin, in an in vitro experiment using VERO cells, reduced the viral titer (load) of SARS-CoV-2 by 75 percent after only 1 hour of preincubation prior to infection at a concentration of 10μM as compared to vehicle control.

  • May 19, 2020 - CytoDyn Inc. announced it will be coordinating with the NIH of Mexico and providing leronlimab for a clinical trial for the treatment of severe - critical COVID-19 disease population in Mexico.

  • May 19, 2020 - Scientists in China believe a new drug can stop pandemic 'without a vaccine.' Xie said his team had been working "day and night" searching for the antibody. "Our expertise is single-cell genomics rather than immunology or virology. When we realized that the single-cell genomic approach can effectively find the neutralizing antibody we were thrilled."

  • May 18, 2020 - BioSig Technologies, Inc. announced that the U.S. FDA has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.

  • May 18, 2020 - Vir Biotechnology, Inc. announced the publication of research findings from the company’s efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. Additionally, Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831, and VIR-7832, in collaboration with GlaxoSmithKline.

  •  May 18, 2020 - CytoDyn Inc. announced it will be submitting a protocol to the U.S. FDA for a factorial design trial to compare the effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19 disease. CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the USA.

  • May 15, 2020 - Sorrento Therapeutics, Inc. announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration. As recently announced, Sorrento aims to generate an antibody cocktail product that would act as a "protective shield" against SARS-CoV-2 coronavirus infection and remain effective even if virus mutations render a single antibody therapy less effective over time.

  • May 14, 2020 - RESTEM, a leading cell-based therapeutics company, announced it has received approval from the U.S. FDA for a 60-patient Phase I/IIa study using the umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the USA.
  • May 14, 2020 - Abivax SA announced that ABX464 inhibits replication of SARS-CoV-2 in an in vitro reconstituted human respiratory epithelium model, as assessed by Transepithelial electrical resistance and RTqPCR. ABX464 has already been shown to be an effective drug candidate in severe inflammatory disease, ulcerative colitis. 
  • May 11, 2020 - Bellerophon Therapeutics, Inc. announced that the U.S. FDA accepted its Investigational New Drug application, allowing the Company to initiate a Phase 3 study of INOpulse® inhaled nitric oxide therapy in up to 500 patients infected with COVID-19.
  • May 8, 2020 - The Lancet: New triple antiviral drug combination shows early promise for treating COVID-19 in phase 2 randomized trial. Early triple antiviral therapy was safe and superior to lopinavir–ritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19.
  • May 8, 2020 - A new, non-peer-reviewed study found Famotidine, which is known as Pepcid, was associated with reduced risk of intubation or a fatality in hospitalized COVID-19 patients. The research said 'patients who took this heartburn medicine while hospitalized for COVID-19 were more than 2x as likely to survive the infection.
  • May 8, 2020 - Sorrento Therapeutics, Inc. and Mount Sinai Health System have agreed to join forces in the investigation and development of an antibody cocktail (COVI-SHIELD™) to potentially treat COVID-19.
  • May 8, 2020 - Arch Biopartners Inc. announced it has received a No Objection Letter from Health Canada to conduct a Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation experienced by patients with COVID-19.
  • May 8, 2020 - PluristemTherapeutics Inc. announced today that the U.S. FDA has cleared the Company’s IND application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome.
  • May 4, 2020 - Junshi Biosciences and Eli Lilly and Company announced they have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus.
  • May 4, 2020 - Vir Biotechnology, Inc. and Alnylam Pharmaceuticals, Inc. announced that they have selected a development candidate for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome. The companies plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19.
  • May 4, 2020 - CytoDyn Inc. a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the Company is expecting enrollment completion for its 75 patient, Phase 2 double-blinded, placebo-controlled, randomized study by the end of this month.
  • May 1, 2020 - The U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
  • May 1, 2020 - A Phase 2 multiple-dose phase 2 study of the PUL-042 inhalation solution in reducing the severity of COVID-19 disease in adults who are positive for SARS-CoV-2 infection. This study is sponsored by Pulmotect, Inc., which has collaborated with MD Anderson and Texas A&M University researchers.

April COVID-19 Disease Treatment News

  • April 30, 2020 - Glenmark Pharmaceuticals announced that it has received approval from the Drug Controller General of India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 disease patients. The product is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation.

  • April 29, 2020 - Gilead reported topline results from the open-label, Phase 3 SIMPLE trial, the time to clinical improvement with Remdesivir for 50 percent of patients was 10 days in the 5-day treatment group, and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14.

  • April 28, 2020 - Innate Pharma SA announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 disease patients with severe pneumonia.

  • April 28, 2020 - PharmaMar announced the start of the APLICOV-PC clinical trial with Aplidin® (plitidepsin), for the treatment of patients with COVID-19, which has been authorized by the Spanish Medicines and Healthcare Products Agency.

  • April 27, 2020 - Tocilizumab was reported to improve clinical outcomes of patients with moderate or severe COVID-19 pneumonia. Patients were selected on the basis of being hospitalized for COVID-19 moderate or severe pneumonia not requiring intensive care upon admission. The primary composite outcome was the need for ventilation (non-invasive or mechanical) or death at day 14. A total of 129 patients were randomized: 65 to the standard of care + tocilizumab and 64 to the standard of care alone.

  • April 27, 2020 - Mateon Therapeutics Inc. announced today it has submitted an IND application to the FDA to study its investigational drug, OT-101, for the treatment of COVID-19 pandemic. The proposed randomized, double-blind, placebo-controlled Phase 2 study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with COVID-19 and pneumonia in the US. OT-101 is a potent inhibitor of SAR-CoV2 replication with efficacy and safety index on par or superior to Remdesivir- a Gilead’s drug. Unlike Remdesivir- OT-101 targets not only the virus replication but also the often lethal clinical sequelae of COVID-19, including pneumonia and fibrosis.

  • April 27, 2020 - Innovation Pharmaceuticals announced the Company has been informed by researchers at the U.S. Regional Biocontainment Laboratory (RBL) that continued coronavirus (COVID-19) testing of Brilacidin, the Company’s defensin-mimetic drug candidate, is scheduled to begin the week of May 4th. Concurrently, the Company is prioritizing Brilacidin’s clinical development by taking steps to rapidly advance Brilacidin testing in human trials. Results from initial testing at the RBL showed that Brilacidin had antiviral activity against SARS-CoV-2 in Vero cells, a screening assay using a monkey epithelial cell-line.

  • April 27, 2020 - Regeneron Pharmaceuticals Inc. and Sanofi SA announced they will discontinue part of a clinical study exploring whether their arthritis therapy, Kevzara, could treat certain hospitalized COVID-19 patients.
  • April 27, 2020 - Aytu BioScience, Inc. announced today that it has signed an agreement with Sterling Medical Devices to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus. The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.
  • April 27, 2020 - CNN reported hospitals in New York are giving COVID-19 patients heartburn medicine. Preliminary results of the clinical trial of famotidine, the active ingredient in Pepcid, could come out in the next few weeks, said Dr. Kevin Tracey, president of Feinstein Institutes for Medical Research at Northwell Health. So far, 187 patients have enrolled in the clinical trial, and Northwell eventually hopes to enroll 1,200, he said.
  • April 24, 2020, the FDA issued a caution against the use of hydroxychloroquine or chloroquine for COVID-19 disease treatment outside of a hospital setting or clinical trial, due to the risk of heart rhythm problems.
  • April 23, 2020 - Eli Lilly reported the company entered into an agreement with the NIAID to study baricitinib as an arm in NIAID's Adaptive COVID-19 Treatment Phase 3 Trial. The company also announced that it will advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome. And, the company entered into an agreement with AbCellera to co-develop antibody products for the potential treatment and prevention of COVID-19. 
  • April 22, 2020 - “The guideline for diagnosis and treatment of COVID-19 issued by WHO and National Health Commission of the People's Republic of China suggests that ribavirin, lopinavir/ritonavir antiviral therapy should be used in COVID-19 patients,” the researchers wrote in the Journal of Internal Medicine.
  • April 21, 2020 - aTyr Pharma, Inc. announced that the U.S. FDA has accepted its Investigational New Drug (IND) application to evaluate its lead therapeutic candidate, ATYR1923, in a Phase 2 study in COVID-19 patients with severe respiratory complications. ATYR1923 has been shown pre-clinically to downregulate T-cell responses, which dampens the inflammatory cytokine and chemokine signaling that has been implicated in these severe COVID-19 cases. ATYR1923 has also been shown to improve lung function, as well as to reduce inflammation and fibrosis, in multiple animal models of immune-mediated acute lung injury, the company said.
  • April 21, 2020 - Vivacelle Bio, Inc., announced it will make VBI-S, available for use in COVID-19 disease patients. Seventy percent of deaths of COVID-19 patients are due to septic shock.  While the intravenous infusion of VBI-S has demonstrated encouraging preliminary results in a phase IIa clinical study, VBI-S remains an experimental drug. 
  • April 20, 2020 - Innovation Pharmaceuticals is pleased to report that based on molecular screening of 11,552 compounds comprising already FDA-approved drugs and those in clinical testing, Brilacidin, the Company’s defensin-mimetic drug candidate targeting COVID-19, was identified as one of the most promising potential inhibitors of SARS-CoV-2, the novel coronavirus responsible for COVID-19. Brilacidin has shown, in cellular assays, direct antiviral activity against SARS-CoV-2, and has been selected for further antiviral testing by researchers at the U.S. Regional Biocontainment Laboratory (RBL) who conducted these initial tests.  
  • April 19, 2020 - The WHO concluded ‘at present, there is no evidence of severe adverse events, acute health care utilization, long-term survival, or quality of life in patients with COVID-19, as a result of the use of NSAIDs.
  • April 13, 2020 - Ridgeback Biotherapeutics announced clearance by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an orally available antiviral compound, EIDD-2801, to begin human testing, as a treatment for COVID-19 disease. EIDD-2801 is an orally bioavailable form of a highly potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. In animal studies of two distinct coronaviruses (SARS-CoV1 and MERS), EIDD-2801 has been shown to improve pulmonary function, decrease body weight loss and reduce the amount of virus in the lung.
  • April 11, 2020 - A new study was performed by researchers at IHU Méditerranée Infection, Marseille, France, of the 1,061 coronavirus infected patients who were treated entirely with hydroxychloroquine and azithromycin, mortality is around 0.5% and that the cure rate is extremely high.
  • April 10, 2020 - Gilead Sciences announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. The detailed results of this analysis were published today in The New England Journal of Medicine.
  • April 9, 2020 - FirstWave Bio, Inc., announced plans to initiate a Phase 2a/2b study with FW-1022, a proprietary oral formulation of Niclosamide, in patients with COVID-19, beginning in mid-2020. With insights emerging into the crucial role of the gastrointestinal (GI) tract in COVID-19 severity and transmission.
  • April 9, 2020 - Gilead Sciences increased the number of participants in 2 ongoing clinical trials for remdesivir, its experimental treatment for COVID-19 disease.
  • April 9, 2020 - Pfizer confirmed a lead compound and analogues are potent inhibitors of the SARS-CoV-2 3C-like (3CL) protease, based on the results of initial screening assays. In addition, preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. Consequently, Pfizer will perform pre-clinical confirmatory studies, including further anti-viral profiling and assessment of the suitability of the lead molecule for IV administration clinically. In parallel, the company is also investing in materials that will accelerate the start of a potential clinical study of the lead molecule to third-quarter 2020, three or more months in advance of earlier estimates, subject to positive completion of the pre-clinical confirmatory studies.
  • April 8, 2020 - CSL Behring and SAB Biotherapeutics announced their partnership to combat the coronavirus pandemic with the rapid development of SAB-185, a COVID-19 therapeutic candidate on track for clinical evaluation by early summer. The therapeutic candidate, SAB-185, is generated from SAB’s proprietary DiversitAb™ platform producing large volumes of human polyclonal antibodies targeted specifically to SARS-CoV-2 coronavirus, the virus that causes COVID-19 disease. 
  • April 7, 2020 - CytoDyn Inc. announced today that Novant Health is initiating patient enrollment in CytoDyn’s Phase 2 randomized clinical trial with leronlimab (PRO 140), a CCR5 antagonist, for COVID-19 patients with mild-to-moderate indications.  Novant Health is the first site in the southeastern United States to initiate this Phase 2 trial. CytoDyn is also initiating a Phase 2b/3 study for severely ill COVID-19 patients. Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis of the data from 50 patients. 

  • April 7, 2020 - Alexion Pharmaceuticals is set to enter the COVID-19 drug development race in the next few days via a single-arm, 100-patient Phase II trial investigating already approved Soliris (eculizumab), according to a source familiar with the trial. If this Phase II trial delivers a positive risk-benefit ratio, it would then pave the way for a 300-patient, randomized trial that would start shortly after.

  • April 7, 2020 - Karyopharm Therapeutics Inc. announced plans to initiate a randomized clinical trial for low-dose, oral selinexor in hospitalized patients with severe COVID-19. Selinexor, marketed as XPOVIO®, is currently approved at higher doses by the FDA as a treatment for patients with relapsed or refractory multiple myeloma. Selinexor is an oral, selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1. In addition to its roles in cancer, XPO1 also facilitates the transport of several viral proteins from the nucleus of the host cell to the cytoplasm1, and it amplifies the activities of pro-inflammatory transcription factors.  

  • April 6, 2020 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will also utilize Vir’s CRISPR screening and machine learning approach to identify cellular targets whose inhibition can prevent viral infection.

  • April 6, 2020 - Ridgeback Biotherapeutics LP and Drug Innovations at Emory, LLC announced that the U.S. FDA has approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback. This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 in the USA.

  • April 6, 2020 –  Biotest, BPL, LFB, and Octapharma have joined an alliance formed by CSL Behring and Takeda Pharmaceutical to develop a potential plasma-derived therapy for treating COVID-19. The alliance will begin the investigational development of one, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19 disease.

  • April 6, 2020 - RedHill Biopharma Ltd. announced that it has received authorization from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee for an expanded access program allowing immediate compassionate use of its investigational drug, opaganib (Yeliva®, ABC294640), in Italy, for patients with confirmed COVID-19 infection with life-threatening clinical manifestations. Approximately 160 patients are planned to be treated in three major hospitals in northern Italy, one of the current major epicenters of the pandemic.

  • April 6, 2020 - Researchers at The University of Texas at Austin are now using new drug delivery formulation technologies to increase niclosamide’s absorption into the body, designing the drug so that it can be inhaled directly into the lungs, which could prove effective at treating and preventing serious COVID-19 virus symptoms in patients.

  • April 03, 2020 - FDA is taking the lead role on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus. The products can be administered to individuals diagnosed with COVID-19.

  • April 2, 2020 - Incyte announced it is working with the U.S. FDA to initiate a Phase 3 clinical trial (RUXCOVID) to evaluate the efficacy and safety of ruxolitinib (Jakafi®) plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19 associated cytokine storm. The collaborative study will be sponsored by Incyte in the United States and Novartis outside of the United States.

  • April 02, 2020 - Emergent BioSolutions Inc. announced that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.

  • April 1, 2020 - Innovation Pharmaceuticals announced it has received data supporting Brilacidin’s direct inhibition of SARS-CoV-2, the novel coronavirus responsible for COVID-19. 

March COVID-19 Disease Treatment News

  • March 31, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced today the initiation of phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug “Avigan Tablet” (generic name: favipiravir) in Japan for patients of COVID-19 disease, a respiratory infection caused by the novel Coronavirus SARS-CoV-2.

  • March 30, 2020 - BARDA and Johnson & Johnson have expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The Company’s aim is to identify potential treatments against the novel coronavirus. J&J and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.

  • March 30, 2020 - CytoDyn Inc. announced that an additional 3 critically ill COVID-19 disease patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug granted by the U.S. FDA. 

  • March 30, 2020 - Bellerophon Therapeutics, Inc. announced that expanded access treatment with the INOpulse® inhaled nitric oxide system (iNO) was initiated for the 1st time in a patient with a diagnosis of the novel coronavirus disease (COVID-19) at the University of Miami School of Medicine. The treatment follows the recent decision by the U.S. FDA to grant emergency expanded access that allows INOpulse to immediately be used for the treatment of COVID-19 under the care and supervision of their physician.

  • March 29, 2020 - Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit's malaria, lupus and arthritis drug hydroxychloroquine is the company's biggest hope against the coronavirus, Swiss newspaper SonntagsZeitung. On March 26th, Novartis has pledged to donate 130 million doses and is supporting clinical trials needed before the medicine, which U.S. President Donald Trump also has been promoting, can be approved for use against the coronavirus.

  • March 25, 2020 - Vir Biotechnology, Inc. announced that it has identified multiple human monoclonal antibody (mAb) development candidates that neutralize SARS-CoV-2, the virus responsible for COVID-19. The ability of this antibody to neutralize the SARS-CoV-2 live virus has been confirmed in two separate laboratories. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved. Vir believes that the conservation of this epitope will make it more difficult for escape mutants to develop.

  • March 24, 2020 - Aldeyra Therapeutics, Inc. announced that it will begin screening its library of novel reactive aldehyde species (RASP) inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and antiviral activity in the treatment of COVID-19 infection.

  • March 23, 2020 – AlloVir announced the expansion of its research and development collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus-specific T-cell therapies to combat SARS-CoV-2, the virus that causes COVID-19.

  • March 22, 2020 - Gilead Sciences issued a statement on access to Remdesivir outside of clinical trials. To streamline the emergency access process, Gilead is currently in the process of transitioning from individual compassionate use requests to expanded access programs. This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. These programs are currently under rapid development in conjunction with national regulatory authorities worldwide and may vary by region based on local laws and regulations.

  • March 20, 2020 - Teva Pharmaceutical announced the immediate donation of more than 6 million doses of hydroxychloroquine sulfate tablets through wholesalers to hospitals across the U.S. to meet the urgent demand for the medicine as an investigational target to treat COVID-19 disease. Although the product is not currently approved for use in the treatment of COVID-19, it is approved by the U.S. FDA for the treatment of malaria, lupus erythematosus, and rheumatoid arthritis.

  • March 19, 2020 - Roche announced they working with the US FDA to initiate a Phase III clinical trial in collaboration with BARDA, a part of the US Health HHS, to evaluate the safety and efficacy of Actemra®/RoActemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

  • March 17, 2020 - Regeneron Pharmaceuticals announced scientists have now isolated hundreds of virus-neutralizing, fully-human antibodies from the company's VelocImmune® mice, which have been genetically-modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19, in order to maximize the pool of potentially potent antibodies. From this large pool of candidates, Regeneron will select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities. 

  • March 16, 2020 - Regeneron Pharmaceuticals, Inc. and Sanofi announced they have started a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 infection. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody.

  • March 13, 2020 - Enanta Pharmaceuticals, Inc. announced that it has initiated a program to discover direct-acting antiviral drug candidates for the treatment of patients infected with the novel coronavirus SARS-CoV-2, which causes COVID-19 disease in humans.

  • March 10, 2020 - An article published in The Guardian said 'the USA, China, and Italy are already using Remdesivir on a compassionate basis to treat small numbers of patients with severe Covid-19 disease.'
  • March 9, 2020 - The Bill & Melinda Gates Foundation, Wellcome, and Mastercard announced the intent to provide seed-funding up to $125 million to speed-up the response to the COVID-19 disease epidemic by launching the COVID-19 Therapeutics Accelerator.
  • March 6, 2020 - Innovation Pharmaceuticals announced a 2nd Material Transfer Agreement to provide Brilacidin to a major U.S. university for analysis. Brilacidin is one of the few drugs targeting COVID-19 disease that has been tested in human trials for other clinical indications, providing an established safety and efficacy profile, developed both as an intravenous medicine and as a possible vaccine.
  • March 5, 2020 - A study published in Cell by German researchers who identified a cellular protein that is important for the entry of the SARS-CoV-2 virus into lung cells. "Our results show that SARS-CoV-2 requires the protease TMPRSS2, which is present in the human body, to enter cells," says Stefan Pöhlmann, head of the Infection Biology Unit at the German Primate Center. "This protease is a potential target for therapeutic intervention."
  • March 4, 2020 - Takeda Pharmaceutical announced that it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals infected with COVID-19 disease, while also studying whether Takeda’s currently marketed and pipeline products may be effective treatments for infected patients.
  • March 3, 2020 - Regeneron CEO Leonard Schleifer told CNBC that the pharmaceutical company hopes to have its coronavirus treatment produced and ready for human testing possibly by August 2020. Understanding the urgency with which the coronavirus needs to be confronted, Schleifer said Regeneron will be pursuing clinical trials and drug manufacturing at once
  • March 2, 2020 - Innovation Pharmaceuticals offers a scientific rationale and clinical development perspective for Brilacidin, the Company’s defensin mimetic drug candidate, as a potential novel coronavirus (COVID-19) treatment. Notably, Brilacidin is one of the few drugs targeting COVID-19 that has been tested in humans in Phase 2 clinical trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help confront the emerging worldwide coronavirus crisis.
  • March 02, 2020 - Mateon Therapeutics, Inc. announced a new division will be dedicated to the development of rapid responses to the current COVID-19 virus outbreak, as well as future virus outbreaks, and will be led by Dr. Cyril Empig, who has been appointed Head of the Rapid Antiviral Response Program.

February COVID-19 Disease Treatment News

  • February 27, 2020 - Innovation Pharmaceuticals announced the signing of a Material Transfer Agreement with one of the country’s 12 Regional Biocontainment Labs (RBL) to research it's lead defensin mimetic drug candidate, Brilacidin, as a potential novel coronavirus treatment. Mechanism of action studies of Brilacidin, along with assessing possible synergistic effects with other antivirals, are also planned. It is anticipated these tests might be completed within several weeks of the RBL’s receipt of Brilacidin.

  • February 26, 2020 - Gilead Sciences, Inc. announced the initiation of Phase 3 clinical studies to evaluate the safety and efficacy of Remdesivir in adults, who are diagnosed with COVID-19 disease, which is caused by the SARS-CoV-2 coronavirus. The initiation of these human clinical studies follows the U.S. Food and Drug Administration’s rapid review and acceptance of Gilead’s investigational new drug filing for Remdesivir for the treatment of COVID-19 patients. Remdesivir is not yet licensed or approved anywhere and has not been demonstrated to be safe or effective for any use.

  • February 25, 2020 - Vir Biotechnology, Inc. and WuXi Biologics announced a development and manufacturing collaboration to advance and produce human monoclonal antibodies for the potential treatment of COVID-19, a disease caused by the SARS-CoV-2 coronavirus. Vir has identified a number of monoclonal antibodies that bind to SARS-CoV-2 and is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

  • February 25, 2020 - A phase 2 clinical trial of Gilead’s experimental drug remdesivir for the novel coronavirus, according to a posting on a government clinical trials database. The trial will be run by the University of Nebraska Medical Center along with the National Institute of Allergy and Infectious Diseases and will be conducted at up to 50 sites globally.

  • February 24, 2020 - Cocrystal Pharma, Inc. Announced License Agreement with Kansas State University Research Foundation for Norovirus and Coronavirus Antiviral Compounds. Cocrystal intends to pursue research and development of these antiviral compounds, including preclinical and clinical development. This license advances the Company's antiviral programs significantly by providing potent compounds for further development.

  • February 23, 2020 - Japan's health minister Katsunobu Kato said the anti-influenza medication Avigan will be used for COVID-19 treatment, as part of an observational study.

  • February 20, 2020 - Beroni Group announced its collaboration with Tianjin University in China to develop a medical solution for the coronavirus (COVID-19) epidemic. A team of scientists from Tianjin University and from Beroni Group is now working to develop a rapid detection method and precision-driven treatment of COVID-19 caused by SARS-CoV-2 infection using nanobody-based technology.

  • February 20, 2020 - WHO Director-General Tedros Adhanom Ghebreyesus said: "Preliminary results from two clinical trials testing potential treatments for the COVID-19 coronavirus are expected in 3 weeks. Even if people are infected, having better outcomes, saving their lives, is really key." One trial combines HIV drugs Lopinavir and Ritonavir, while the other is testing the antiviral Remdesivir.

  • February 18, 2020 - China's National Medical Products Administration has approved the marketing of Favilavir, formerly known as Fapilavir, an antiviral medication that has shown efficacy in treating the novel coronavirus COVID-19. Favilavir was developed by Zhejiang Hisun Pharmaceutical, which is the 1st drug that has been approved for marketing in China. Fapilavir is reported to have demonstrated efficacy with minor side effects in an ongoing 70-patient clinical trial in Shenzhen, Guangdong province.

  • February 17, 2020 - China developed the 5th version for trial implementation of the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia" based on the revisions of the previous version.

  • February 15, 2020, the CDC announced it had grown the COVID-19 virus in cell culture, which is necessary for further studies, including for additional genetic characterization. The cell-grown virus was sent to NIH’s BEI Resources Repositoryexternal icon for use by the broad scientific community.

  • February 13, 2020 - Gilead Sciences antiviral drug prevented disease and reduced the severity of symptoms in monkeys infected with Middle East Respiratory Syndrome (MERS), an infection closely related to the fast-spreading coronavirus that originated in China, reported a study published in the Proceedings of the National Academy of Sciences. The MERS study was supported in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

  • February 12, 2020 - Chinese pharma company BrightGene said it has successfully copied Gilead Science's Remdesivir in a Nasdaq-style China disclosure. The Suzhou-based BrightGene also said it has already mass-produced remdesivir's active ingredient and is in the process of turning it into finished doses.

  • February 7, 2020 - A study published in JAMA reported 'Antibacterial agents are ineffective.' All of the patients in this study received antibacterial agents, 90% received antiviral therapy, and 45% received methylprednisolone. The dose of oseltamivir and methylprednisolone varied depending on disease severity. However, no effective outcomes were observed.

  • February 4, 2020 - HHS and Regeneron Collaborate to Develop 2019-nCoV Treatment. BARDA and Regeneron now will leverage their partnership agreement to develop multiple monoclonal antibodies that, individually or in combination, could be used to treat this emerging coronavirus, also known as 2019-nCoV. These monoclonal antibodies are produced by a single clone of cells or a cell line with identical antibody molecules. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells. Medicines developed for 2019-nCoV through the expanded BARDA-Regeneron partnership will leverage Regeneron's monoclonal antibody discovery platform called VelocImmune, part of the company's VelociSuite technology.

  • February 4, 2020 - A new study published in Nature reports 'Our findings reveal that remdesivir and chloroquine are highly effective in the control of 2019-nCoV infection in vitro.' Since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease.

  • February 4, 2020 - The Lancet - Baricitinib as a potential treatment for 2019-nCoV acute respiratory disease. 'Because the plasma concentration of baricitinib on therapeutic dosing (either as 2 mg or 4 mg once daily) is sufficient to inhibit AAK1, we suggest it could be trialed, using an appropriate patient population with 2019-nCoV acute respiratory disease, to reduce both the viral entry and the inflammation in patients, using endpoints such as the MuLBSTA score, an early warning model for predicting mortality in viral pneumonia.'

  • February 3, 2020 - Zhang Dingyu, president of Wuhan Jinyintan Hospital, said at the news conference 'that the hospital was the first to use lopinavir/ritonavir, which is sold under the brand name Kaletra and a medication for the treatment and prevention of HIV/AIDS, to treat patients with the novel coronavirus. "It seems that Kaletra is effective in patients with early symptoms. It can help prevent the disease from getting severe and life-threatening, but we still need stronger evidence," said Zhang. Zhang warned people that the side effects of Kaletra include gastrointestinal discomfort, allergy, and hepatic damage. Lopinavir/ritonavir is being investigated (Chinese clinical trial registry identifier: ChiCTR2000029308) based on previous studies suggesting possible clinical benefit in SARS and MERS. The research team of Li Lanjuan, one of China's leading scientists in the fight against the novel coronavirus, announced a major breakthrough on Tuesday, China's Changjiang daily reported. Preliminary tests showed that two drugs - Abidol and Darunavir – can effectively inhibit the virus in vitro cell experiments, according to Li, who is also a professor at Zhejiang University. 

  • February 3, 2020 - AntiCancer Inc. said “Oral recombinant methioninase has high potential to slow or arrest infection of 2019-nCoV in patients, with and without symptoms,” said Dr. Qinghong Han, methioninase project leader at AntiCancer. “We will first test methioninase in cultured lung cells infected with 2019-nCoV in vitro, and then test oral recombinant methioninase in patients infected with the virus. We will carry out these tests in China with the appropriate organizations and safety profiles. Oral recombinant methioninase should be an effective therapy for infections caused by the 2019-nCoV since coronaviruses have a special requirement for methionine,”

  • February 2, 2020 – California-based Gilead Sciences issued a statement announcing Washington State health officials used the unapproved antiviral drug Remdesivir to treat the 1st patient diagnosed with the novel coronavirus 2019-nCoV in the U.S.

January COVID-19 Disease Treatment News

  • January 31, 2020 — Gilead Sciences issued a statement from Merdad Parsey, M.D., Ph.D., Chief Medical Officer, Gilead Sciences: "Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir." Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.

  • January 27, 2020 - AbbVie’s fixed-dose HIV drug Kaletra—also known as Aluvia, is now recommended as a treatment for pneumonia caused by the new coronavirus known as 2019-nCoV, China’s National Health Commission says in its updated clinical guidance. Kaletra’s 2 antiretroviral components, lopinavir, and ritonavir are protease inhibitors designed to block HIV viral replication. One hypothesis holds that the drugs could do the same with 2019-nCoV, which is believed to have originated from the Chinese city of Wuhan. Although not approved to treat any coronavirus anywhere, it has shown efficacy in at least one case in the current outbreak in China.

  • Thailand doctors combined the anti-flu drug oseltamivir with lopinavir and ritonavir, antivirals used to treat HIV. The ministry was awaiting research results to prove the findings.

Note: This content was last reviewed by health care professionals, such as Dr. Robert Carlson.