ACT Trial - Anti-Coronavirus Therapies to prevent COVID-19 progression trial

COVID-19 is a global pandemic. Various treatments have the potential to prevent disease progression but so far few have been proven to be effective.

This program will evaluate anti-viral, anti-inflammatory, and anti-thrombotic therapy to determine whether they prevent clinical progression of COVID-19 in outpatients and inpatients

Study Design: Parallel group trial with factorial randomization

Duration: The primary outcome is at 45 days after randomization. All participants will be followed for 6 months from randomization in both trials.

Clinical Outcome and Mortality:
(1) Outpatients with mild disease: The primary outcome is the composite of hospitalization or death.
(2) Inpatients with moderate or severe disease: The primary outcome is need for mechanical ventilation or death.

Sample Size:
Global sample size: 4000 (to be recruited)
India: 2000

Study Update: In the process of site selection and regulatory submissions; recruitment yet to start.

                                                                                                                                                                                                 Updated as of 3rd Sep, 2020

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