Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Sep 23, 2020 • 3:03 pm CDT

Convalescent Plasma Studies Launched by the U.S. NIH

Additional clinical trials funded by the US National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma treatments for patients hospitalized with COVID-19. These studies are needed as observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19.

However, prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19, stated the NIH’s press release published on September 22, 2020.

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Don Ward Hackett

Sep 23, 2020 • 2:08 pm CDT

Coronavirus Infection Rates Vary by US State

A majority of the USA remains susceptible to a SARS-CoV-2 coronavirus infection, the director of the Centers for Disease Control and Prevention (CDC), told lawmakers on September 23, 2020. The infection rate ranges up to 20% of the population in some US states, and less than 1% in others, the director said, according to CNBC.

Dr. Robert Redfield stated on Twitter 'the CDC recommends that you wear masks in public settings around people who don’t live in your household and when you can’t stay 6 feet away from others. Masks help stop the spread of COVID-19 to others,' says Dr. Redfield.

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Karen McClorey Hackett

Sep 23, 2020 • 8:53 am CDT

J&J Launches Large Phase 3 Coronavirus Vaccine Study

Johnson & Johnson announced on September 23, 2020, the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, Ad26.COV2-S, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. ENSEMBLE will enroll up to 60,000 volunteers across (3) continents and will study the safety and efficacy of a single vaccine dose of Ad26.COV2-S versus placebo in preventing COVID-19.

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Don Ward Hackett

Medical Review by

Danielle Reiter, RN

Sep 23, 2020 • 7:28 am CDT

Avigan Increased COVID-19 Recover Time

Japan-based Fujifilm Toyama Chemical Co. announced on September 23, 2020, its phase III trial evaluating Avigan was now complete, and it intends to apply for the antiviral medication to be approved for treating coronavirus patients after the trials showed the median recovery time was 11.9 days in those receiving Avigan, compared with 14.7 for patients given a placebo.

Avigan's generic name is favipiravir, was approved for use in Japan in 2014, but only for influenza outbreaks. Favipiravir, which can be taken orally as a pill, works by blocking the ability of a virus to replicate inside a cell.

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Don Ward Hackett

Medical Review by

Danielle Reiter, RN

Sep 23, 2020 • 5:44 am CDT

Most People Will Not Remain Asymptomatic While Infected

The findings of a new living systematic review published by PLOS on September 22, 2020, suggest that most people who become infected with the SARS-CoV-2 virus .... 'will not remain asymptomatic throughout the course of the infection.'

These researchers stated: 'the findings from systematic reviews, including this new one, do not support the claim that a large majority of SARS-CoV-2 infections are asymptomatic.'

These researchers estimated that, across all study settings, the proportion of SARS-CoV-2 infections that are asymptomatic throughout the course of infection is 20% (95% CI 17%–25%).

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Don Ward Hackett

Medical Review by

Robert Carlson, MD

Sep 23, 2020 • 4:49 am CDT

'World Patient Safety Day' Focuses on Worker Protections

The COVID-19 pandemic during 2020 presents a stark reminder of the importance of health worker safety and offers 'too many examples of health workers becoming infected and dying from COVID-19. The harsh consequences of inequalities have also been laid bare by the pandemic,' states a new commentary published by The Lancet.

As everyone marks the WHO's World Patient Safety Day 2020 on September 17,2 020, it is crucial to highlight that there can be no patient safety ...' without health worker safety. One cannot exist without the other.'

As in previous outbreaks of Ebola virus disease, MERS, and SARS-1, only when health workers are safe can they keep patients safe. Furthermore, 'Governments and healthcare organizations must act now to support and protect the health workforce ... so that we can provide safe care for our patients,' concluded this editorial.

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Don Ward Hackett

Sep 22, 2020 • 2:19 pm CDT

Canada Buys 72 Million Coronavirus Vaccine Doses

The Government of Canada agreed to purchase up to 72 million doses of an adjuvanted COVID-19 vaccine beginning in 2021 from Sanofi and GSK on September 22, 2020. Both companies have vaccine manufacturing sites in Canada that are contributing to overall global COVID-19 vaccine development.

These companies initiated a Phase 1/2 study on September 3, 2020, with a total of 440 subjects and anticipate results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of 2020. If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021.

In the aggregate, Canada has committed about $1 billion to buy at least 154 million doses of vaccines from (5) different companies.

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Don Ward Hackett

Sep 22, 2020 • 2:00 pm CDT

Digital Health Technologies Addressing COVID-19 Awarded by the NIH

The National Institutes of Health (NIH) announced on September 15, 2020, has awarded contracts to (7) companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic.

The proposed digital health tools will leverage multiple data sources, including wearable devices and COVID-19 diagnostic and serology test results. Each organization will share data and other assets in an NIH-supported central data hub in ways that protect individuals’ privacy.

These companies are listed on this NIH webpage.

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Don Ward Hackett

Sep 22, 2020 • 1:47 pm CDT

Brazil Approves Phase 2/3 COVID-19 Study with Orally-Administered Opaganib

The Brazilian Health Regulatory Agency has approved RedHill Biopharma's ongoing global Phase 2/3 study evaluating orally-administered opaganib in patients hospitalized with severe COVID-19 pneumonia. Announced on September 22, 2020,

Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance.

Opaganib completely inhibited SARS-CoV-2 viral replication in an in vitro human lung cell model, comparing favorably with remdesivir, the positive control in the study.

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Karen McClorey Hackett

Sep 22, 2020 • 6:39 am CDT

'No Approved Drugs or Vaccines' Says the FDA

A new video published by the U.S. FDA on September 21, 2020, entitled, Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments, explains to consumers that there are currently no FDA-approved drugs or vaccines to treat or prevent COVID-19.

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Karen McClorey Hackett

Sep 21, 2020 • 1:18 pm CDT

CDC Removes New Coronavirus Transmission Guidelines

During the afternoon of September 21, 2020, the U.S. CDC removed from the website the revised SARS-CoV-2 coronavirus transmission guidance it published on September 18, 2020. According to the WSJ, the CDC stated 'it had posted a draft version of proposed changes in error.'

'The CDC is currently updating its recommendations regarding the airborne transmission of the new virus that causes COVID-19. Once this process has been completed, the updated language will be posted.'

This is a developing story.

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Karen McClorey Hackett

Medical Review by

Danielle Reiter, RN

Sep 21, 2020 • 11:03 am CDT

China Coronavirus Vaccine Launches Phase 3 Study in Russia

Petrovax announced on September 21, 2020, it will be able to produce more than 4 million doses of CanSino Biologics's Ad5-nCoV vaccine per month in 2020 at its Moscow Region facilities. And, vaccine production can be increased to 10 million doses per month in 2021 due to the planned expansion of production capacity. As a Russian vaccine manufacturer, Petrovax will have exclusive rights to supply China-based CanSino's vaccine in Russia and the CIS countries.

Additionally, the first group of volunteers participating in an international Phase III clinical trial of the Ad5-nCoV vaccine were vaccinated at Moscow medical centers.

According to clinical regulations, study participants will be under direct supervision for the first 28-days after vaccination and will have to undergo (4) interim face-to-face examinations at treatment centers. According to expert forecasts, during this period, the Ad5-nCoV vaccinated subjects will develop an antibody and cellular immune response to COVID-19.

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Don Ward Hackett

Sep 21, 2020 • 7:30 am CDT

Coronavirus Detected in Sewage Ahead of Outbreaks

A new study published on September 18, 2020, measured SARS-CoV-2 RNA concentrations in primary sewage sludge in the New Haven, Connecticut, during the Spring of 2020. SARS-CoV-2 RNA was detected throughout the study.

"Our data show the utility of viral RNA monitoring in municipal wastewater for SARS-CoV-2 infection surveillance at a population-wide level. In communities facing a delay between specimen collection and the reporting of test results, immediate wastewater results can provide considerable advance notice of infection dynamics," stated these researchers.

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Don Ward Hackett

Sep 21, 2020 • 6:17 am CDT

Coronavirus Spreads Through Respiratory Droplets Says the U.S. CDC

On September 18, 2020, the U.S. CDC confirmed the new coronavirus is spread through respiratory droplets, or small particles, such as aerosols produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into an unsuspecting person's nose, mouth, airways, and lungs and cause infection.

The CDC says 'this is thought to be the main way the SARS-CoV-2 virus spreads between people.'

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Karen McClorey Hackett

Medical Review by

Robert Carlson, MD

Sep 21, 2020 • 5:22 am CDT

Abbott's COVID-19 Test Re-Authorized

The U.S. FDA reissued the Emergency Use Authorization for the Abbott ID Now COVID-19 test on September 17, 2020. This coronavirus diagnostic test is Indicate for specimens collected “from individuals who are suspected of COVID-19 by their healthcare provider within the first 7-days of the onset of symptoms.

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Don Ward Hackett