Enrollment in NCT04292899 has increased from 2,400 to 6,000 patients with severe COVID-19 infections. Just 2 weeks ago, Gilead had increased the trial size from 400 to 2,400. The trial is still projected to be completed in May 2020 with a primary endpoint of improvement on day 14 as measured on a seven-point scale that runs from death to not hospitalized. Data from the first 400 patients in the 2,400 patient trial was locked on 4/16/2020 and may be announced by the end of April.
The result from the Gilead sponsored trial in patients with mild-to-moderate COVID-19 (NCT04292730) is estimated to be available in May 2020. Results from the NIAID sponsored placebo-controlled trial (NCT04280705) are also expected to be available in May.
An unreviewed, unedited article described an animal trial sponsored by Gilead and NIH, where early treatment with remdesivir reduced pulmonary disease and viral titers in rhesus macaques.
Hydroxychloroquine and Chloroquine
Novartis will compare hydroxychloroquine and hydroxychloroquine plus azithromycin to placebo in 450 hospitalized patients with moderate-to-severe COVID-19 that are not on ventilators.
University of Massachusetts researchers are comparing favipiravir to standard of care in a 50 COVID-19 patient trial and Stanford researchers are evaluating the drug in a 120 patient trial of mixed severity COVID-19.
General COVID-19 Research News
NIH has formed the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership with HHS, FDA, CDC, EMA and AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Evotec, GlaxoSmithKline, J&J, KSQ Therapeutics, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Takeda and Vir. ACTIV will coordinate and prioritize trials to optimize vaccine and treatment development for COVID-19 through a steering committee of representatives of members. In mid-April, there were 657 COVID-19 trials with 304 of the trials being listed as active or recruiting. It is hoped that by coordinating trials, research centers will not be overwhelmed, and patient recruitment will be improved. The steering committee will also prioritize research on the most promising candidates.
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