COVID-19 Update for 5/26/2020
In the 29-day, 1,059 patient, Phase III, Adaptive COVID-19 Treatment Trial (ACTT-1) trial (NCT04280705), where patients treated with remdesivir for up to ten days had a median time of recovery (hospital discharge or returning to normal activity level) of 11 days compared to 15 days with placebo in patients with severe COVID-19. There was a non-significant difference in the mortality rate of 8% with remdesivir compared to 11.6% with placebo.
Hydroxychloroquine and Chloroquine
A retrospective analysis of 96,032 patients from a multinational COVID-19 infection registry compared patients that received chloroquine alone, chloroquine with a macrolide, hydroxychloroquine alone, or hydroxychloroquine with a macrolide to patients who received none of these treatments. The analysis found no benefit for chloroquine or hydroxychloroquine with or without a macrolide and the data suggested an increase in morbidity due to a higher incidence of arrhythmias. Due to the results of this trial, the WHO has put a hold on the hydroxychloroquine arm of the trial for a safety review.
In an unreviewed, unedited report of a 195 patient trial, 39 patients that received a single transfusion of convalescent plasma required the same or less supplemental oxygen and non-intubated patients had a mortality benefit compared to a set of retrospectively selected matched controls in hospitalized patients with severe COVID-19.
BARDA has provided AstraZeneca a $1 billion grant to fund a 30,000 patient Phase III trial in the U.S. and the rights to 300 million doses of the AZD1222 vaccine that will start being delivered in October. Oxford began recruiting patients for a 10,260 patient, Phase II trial in May 2020
In a 28-day, 108 patient, Phase I, dose escalation, open-label trial, healthy Chinese patients developed antibodies after receiving a single immunization with CanSino’s Ad5-nCoV, but patients with high Ad5 antibody titers produced lower levels of COVID-19 antibodies. Most patients experienced a mild to moderate adverse event with the most common being injection site pain, fever, fatigue, headache and muscle pain. CanSino is developing the non-replicating adenovirus type-5 (Ad5) viral vector, (Ad5-nCoV) vaccine. Because the vaccine is Ad5 vectored and most adults have immunity to Ad5, the efficacy in older patients may not be as strong as in younger patients. Based on preliminary safety data from the first 14-days of the Phase I trial, CanoSino initiated a 500 patient, Phase II trial for Ad5-nCoV in May using the low and middle doses of the vaccine.
Novavax initiated a 130 patient, Phase I/II trial (NCT04368988) for NVX-CoV2373 in May 2020 with initial immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
MediciNova is evaluating ibudilast as a treatment for acute respiratory distress syndrome (ARDS) in patients with serious and critical COVID-19 infection.
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