Coronavirus Breaking News

Enlivex Therapeutics Ltd. reported positive interim results of an investigator-initiated Phase II clinical trial evaluating Allocetra in treating severe and critical COVID-19 patients. Allocetra™ is an immunotherapy that is being developed to rebalance a life-threatening unbalanced immune system, using the immune system’s own natural regulation mechanisms.

Prof. Vernon van Heerden, Head of the Critical Care Medicine Unit at Hadassah Hospital in Israel, and the lead investigator of both the prior Phase Ib and the current Phase II COVID-19 clinical trial stated in a press release, "Thirteen COVID-19 patients have been treated to date with Allocetra. The Phase II patients that have been discharged from the hospital are currently healthy."

"We believe that these compelling preliminary results have demonstrated safety and an indication of the efficacy of Allocetra in these complicated patients, highlighting the potential of Enlivex's product candidate to benefit severe and critical COVID-19 patients as well as others suffering from cytokine storms and organ dysfunctions across various clinical indications."

Moderna Inc. launched the TeenCove vaccine study on December 2, 2020. This phase 2/3 clinical trial of about 3,000 adolescents will evaluate the safety, reactogenicity, and effectiveness of the experimental mRNA-1273 vaccine candidate in participants 12 to <18 years old to prevent COVID-19, which is caused by an infection from the SARS-CoV-2 virus.

The mRNA-1273 vaccine will be administered in 2-doses, 28 days apart to this adolescent population.

The NCT04649151 study's estimated completion date is June 30, 2022.

The Centers for Disease Control and Prevention (CDC) announced it has revised quarantine guidelines for people who may have been exposed to the SARS-CoV-2 coronavirus. The CDC stated on December 2, 2020, that potential virus exposure warrants a quarantine of 10 or seven days, depending on one's test results and symptoms.

If individuals do not develop symptoms, they should quarantine for 10 days. If they test negative, that period can be reduced to just 7-days.

Dr. John Brooks, with the CDC's COVID-19 response team, said this revision was based "on extensive modeling, not just by CDC, but by other agencies and partners."

Roche Diagnostics announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization from the U.S. FDA. The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell.

'Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time,' stated Roche's press release issued on December 2, 2020.

Thomas Schinecker, CEO of Roche Diagnostics said: “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response”.

After completing a clinical trial evaluating its super pulsed laser therapy technology to improve respiratory function in critically ill COVID-19 patients, medical device manufacturer Multi Radiance Medical (MRM) announced it is preparing to apply for emergency use authorization with the US Food and Drug Administration.

The triple-blind, placebo-controlled clinical trial results show that MRM super pulsed laser therapy decreased invasive intubation time/need by 18% overall, and decreased mechanical ventilation time/need overall by 23%.

“Increased thickness of the diaphragm has been associated with improved inspiratory function and increased vital capacity over time,” stated Dr. Ernesto Leal-Junior, MRM Lead Researcher, in a press release. “This is the first clinical evidence that super pulsed laser therapy can significantly improve symptoms of the critically ill.”

The sovereign wealth fund of the Russian Federation and the ChemRar group of companies announce an increase in production of the first Russian drug against the new coronavirus infection, Avifavir. The medication production level in Russia is now 200,000 packs per month.

Avifavir (favipiravir) is the first drug in the world with the active ingredient favipiravir, registered for the treatment of new coronavirus infection, stated an RDIF press release issued on November 30, 2020.

Previously on November 20th, the Ministry of Healthcare of the Russian Federation confirmed the 'permanent registration of Avifavir, which enables the drug can be used both in outpatient and inpatient settings, it is advisable to prescribe it from the first days of the disease.'

Based on National Center for Health Statistics (NCHS) Mortality Surveillance data available on November 25, 2020, 11.3% of the deaths occurring during the week ending November 21, 2020 (week #47), were due to pneumonia, influenza, and COVID-19 (PIC).

Among the 2,000 PIC deaths reported by NCHS for week #47, over 1,100 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, and just 5 listed influenza, indicating that the current increase in PIC mortality is due primarily to COVID-19, and not influenza.