NIH reports results from an interim data analysis from a large randomized trial of remdesivir.
Some specifics:
* The trial is called the Adaptive COVID-19 Treatment Trial sponsored by the NIAID of the NIH and is the first clinical trial launched in USA for COVID-19 treatment.
* The trial is an international, multi-center study so has the potential to be more representative than studies at one site. It included 68 total sites -- 47 in the USA and 21 in Europe and Asia.
* The trial enrolls hospitalized patients, and the initial protocol called for 572 patients.
* The trial is a double-blinded placebo-controlled randomized trial of remdesivir vs. placebo. This is the strongest type of clinical trial that can be done, as the patient and doctor have no way of knowing whether the drug received by the patient is remdesivir or placebo.
* The primary endpoint is time to recovery, which they define to be release from hospital. One of the secondary endpoints is mortality rate.
Results:
* The trial is not completed, but the data and safety monitoring board DSMB met and seeing these results, decided it was essential to report these results.
* For the primary endpoint, the remdesivir patients had a 31% faster time to recovery which was highly statistically significant (p<0.001), with 11 days for redmesivir patients and 15 days for placebo.
* This effect size is similar to Theraflu's efficacy for treating influenza patients.
* The mortality rate for remdesivir was 8.0% and for placebo was 11.6%, which is also a reduction of 31% in mortality rate, but the p-value was only marginally statistically significant (p=0.059). Additional data will accrue on this endpoint so in the final analysis it has a chance of reaching statistical signfiicance.
This is really good news -- the best study to date of any COVID-19 treatment, and very clear positive results!
Some questions I have:
* What is the sample size for this interim report, and are more patients accruing?
* The entry criteria is hospitalized confirmed COVID-19 patients. I don't see anything about whether they enroll patients with moderate or severe symptoms or both, what co-morbidities they might have, or whether they allow patients who are in ICU to enroll. Given the heterogeneity of the disease and disease course, these subtype analyses are important to establish for what patients remdesivir works, and at what timepoint in the disease progression it is most effective.
This overcomes the unwarranted negativity towards this drug just because some clinical trials in China, that were not accruing because of disease control there, were stopped.
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