The race is on to find a COVID-19 vaccine or treatment. As a result, there are many clinical trials taking place around the world. At the same time, COVID-19 is also impacting ongoing clinical trials for other serious illnesses.
This news digest includes the latest on clinical trials, both advancements to speed up COVID-19 trials and impacts of the pandemic on ongoing clinical trials.
- Pfizer and BioNTech propose expansion of pivotal COVID-19 vaccine trial. The companies have submitted an amended protocol to expand the enrollment of their Phase III pivotal COVID-19 vaccine trial to up to 44,000 participants. Read more.
- UK’s MHRA allows restart of Oxford/AstraZeneca COVID-19 vaccine trials. The Medicines Health Regulatory Authority (MHRA) in the UK has said that the clinical trials of the Oxford/AstraZeneca COVID-19 vaccine candidate are safe to resume. The late-stage trials were paused after a participant in the UK study experienced an unexplained illness. Read the full article.
- Biopharma leaders unite to stand with science. Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. Read the pledge.
- Sanofi and GSK move COVID-19 vaccine into human trials. Sanofi and GSK are launching a large Phase I/II clinical trial at 11 sites across the US, initially enrolling 400 people. This candidate is the first outside of China to use a vaccine approach for which there is already a licensed vaccine. Read the full article.
- Sanofi says Kevzara drug fails as possible COVID-19 treatment. The international Phase III clinical trials of Kevzara didn't meet primary or secondary endpoints and as a result trials will be stopped. Read the full article.
- Phase III clinical testing of AstraZeneca COVID-19 vaccine candidate begins. A multi-site, Phase III clinical trial for AZD1222 has begun. The trial will enroll 30,000 adult volunteers at 80 sites in the US. Read more.
- Translate Bio, Sanofi COVID-19 vaccine proves promising in animal studies. Experimental COVID-19 vaccine induced immune responses in animal studies. The companies plan to start human trials in November. Read the full article.
- COVID-19 and readjusting clinical trials. The disruptions from the pandemic are numerous, but there are some reasons to be optimistic about changes with clinical trials, according to the Lancet. Read the full article.
- COVID-19 clinical trials must append more diversity, researchers assert. Researchers raise concerns about the lack of diversity in COVID-19 clinical trials. Read the full article.
- Disruptions to global oncology trials have fallen to a three-month low. Cancer trials disrupted by COVID-19 are resuming faster than other therapeutic areas. Read the full analysis.
- FDA Coronavirus Treatment Acceleration Program (CTAP) dashboard. This dashboard provides updates specifically on therapeutics (not vaccines or devices). View dashboard.
- Many early COVID-19 studies have low-quality design, risk low-value evidence, research finds. The researchers estimated that only about 29% of studies would produce data strong enough to potentially inform changes in clinical care. Read the full article.
- US biotech uses AI to pick antiviral for COVID-19 trial. US biotech AI Therapeutics begins a Phase II trial of its LAM-002A, an antiviral drug. The company develops drugs identified with a proprietary artificial intelligence (AI) algorithm. Read the full article.
- "Promising" data on Oxford/AZ coronavirus vaccines. Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus. Read the full article.
- Moderna COVID-19 vaccine candidate has positive results in all participants in Phase I trial. Moderna published interim analysis of the open-label Phase 1 study of mRNA-1273 in the New England Journal of Medicine. A Phase III trial is expected to start later in July. Read the report.
- NIH launches trials network for COVID-19 vaccines and therapies. The COVID-19 Prevention Trials Network (COVPN) is expected to operate more than 100 trial sites across the US and internationally. The first Phase III trial conducted is expected to be Moderna’s mRNA-1273 vaccine. Read the full article.
- UK universities launch new COVID-19 drug testing platform. The University of Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit launched a COVID-19 drug testing platform called AGILE. It will test multiple potential therapeutics. Read the full article.
- UK trial begins testing second-wave COVID-19 drug from US biotech Ridgeback. Ridgeback Biotherapeutics is starting enrollment for a Phase II trial for its oral antiviral drug EIDD-2801, which will be conducted using the AGILE testing platform. Read the full article.
- Running clinical trials for other drugs in the age of COVID-19. There is some evidence of recovery for clinical trials beyond COVID-19. Read the full article.
- Some COVID-19 trial sponsors never posted other study results in an EU database. Will they hide data again? Two-thirds of 118 COVID-19 clinical trials analyzed by the non-profit research advocacy group TranspariMED had no record of uploaded results to the European Union Drug Regulating Authorities Clinical Trials Database, though it is required under EU rules. Read the full article.
- MHRA instructs all UK hydroxychloroquine COVID-19 clinical trials to suspend recruitment. UK clinical trials using hydroxychloroquine to treat or prevent COVID-19 should stop recruiting further participants, Medicines and Healthcare products Regulatory Agency (MHRA). Read the full article.
- COVID-19 vaccine development pipeline gears up. There are 10 COVID-19 vaccines in clinical trials. They are working at a rate that could defy usual timetables, which on average is 10 years to develop a new vaccine. Read the full article.
- FDA’s MyStudies app provides platform for electronic informed consent. The U.S. Food and Drug Administration is making its FDA MyStudies app available to investigators for free to obtain informed consent from patients when face-to-face contact is not possible or practical due to COVID-19. Read the full article.
- How COVID-19 could improve clinical trial conduct. Sheuli Porkess Director, Research, Medical and Innovation from the Association of the British Pharmaceutical Industry talks about three areas for change with clinical trials. Read the full article.
- The COVID-19 pandemic and clinical trial disruptions. Nearly 70% of global clinical trials have been disrupted by enrollment suspensions, according to research. Read the full article.
- FDA updates COVID-19 clinical trials guidance to address serious adverse events. The FDA updated guidance for clinical trial conduct, including how and when serious adverse events should be reported. Read the full article.
- Institute for Advanced Clinical Trials for Children launches program to speed up COVID-19 pediatric trials. The Institute for Advanced Clinical Trials for Children (I-ACT for Children) launched the COVID-19 Emergency Access Program to speed up the development of pediatric COVID-19 trials. Read the full article.
- Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? Researchers will need to adjust their studies during the pandemic. Disruptions to movement and visit schedules and/or sickness or death caused by COVID-19 could impact the data of ongoing clinical trials. Read the full article.