Projects

ACT Study - Anti-Coronavirus Therapies (ACT) to prevent progression of COVID-19: Randomized trials
Details

a) Background:

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.

b) Aim

This program will evaluate anti-inflammatory and anti-thrombotic therapy to determine whether they prevent clinical progression of mild COVID-19

c) Objectives:

  • Colchicine vs. Control prevents progression to moderate/severe disease requiring hospitalization or death (primary) or disease progression by 2 points on a 7-point scale (co-primary).
  •  ASA vs. control prevents progression to moderate/severe disease requiring hospitalization or death (primary), the composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death) (co-primary) or disease progression by 2 points on a 7-point scale (co-primary).

d) Methods

The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries. Patients in the community aged 30 years and older with symptomatic, laboratory confirmed COVID-19 who were within 7 days of diagnosis and at high risk of disease progression were randomly assigned (1:1) to receive colchicine 0·6 mg twice daily for 3 days and then 0·6 mg once daily for 25 days versus usual care, and in a second (1:1) randomisation to receive aspirin 100 mg once daily for 28 days versus usual care. Investigators and patients were not masked to treatment allocation. The primary outcome was assessed at 45 days in the intention-to-treat population; for the colchicine randomisation it was hospitalisation or death, and for the aspirin randomisation it was major thrombosis, hospitalisation, or death.

e) Sample size:

Global -3500 / India 300

f) Study update:

India has randomized 77 patients

g) Publication status (Name & year) & link: Published in Lancet; Oct 2022

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00299-5/fulltext

Updated as on: 22 Nov 2023