Clinical Trial Info

Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PROVENT)

Authored by
Staff
Last Reviewed
October 14, 2021

This Phase 3 study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to a placebo to prevent COVID-19.

The actual enrollment of this trial is 5,197 participants. Arm 1, approximately 3,433, will receive a single dose of 300 mg of AZD7442, while arm 2, about 1,717 will receive a saline placebo.

Results

AstraZeneca presented at IDWeek an abstract of this PROVENT study. The company shared that  AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo.

There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442.

In the placebo arm, the company reported three cases of severe COVID-19, including two deaths.

A key selling point for AstraZeneca’s LAAB is that more than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.