WHO seeking comment on proposed master protocol to study potential COVID-19 therapies
WHO has released a proposed master protocol for COVID-19 therapies and is developing a master protocol proposal for vaccines.
The deadline for responding to the call for public comments on the draft master protocol for therapeutics is March 4.
WHO has also published a broad outline of a Phase IIb/III COVID-19 vaccine master protocol.
The therapeutic master protocol will be an adaptive, randomized, double-blind, placebo-controlled clinical Phase II trial designed to evaluate safety and efficacy in hospitalized adult COVID-19 patients.
The draft design envisions up to 50 sites globally.
Multiple investigational therapies will each be compared to a placebo arm. If and when one agent is demonstrated to be superior to others in the trial, that agent will replace placebo as the control arm.
The proposed primary outcome is the condition of a patient on a 7-point ordinal scale at day 15. The scale will be defined based on blinded review of data from a pilot phase involving the first 100 subjects.
Initially, WHO is considering a two-arm study with about 400 patients randomized to receive either remdesivir or placebo.
If and when additional agents are added the study size will be adjusted.
Last week, NIH said it was beginning the first U.S. clinical trials for COVID-19 with an adaptive trial of remdesivir, an antiviral therapeutic, and a Phase I trial of Moderna’s vaccine candidate (see “U.S. Testing of Coronavirus Vaccine, Therapeutic”).