Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial — ACTCOVID19  

Coronavirus Clinical Trial

Official title: Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial

Status Completed

Clinical Trial Summary

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

Clinical Trial Description

The ACT COVID-19 program consists of two parallel trials testing the effects of interventions in complementary populations in outpatients and inpatients. In the outpatient study, symptomatic patients in the community who are COVID-19 positive and at high risk of disease progression: colchicine compared with control (anti-inflammatory); and ASA compared with control (anti-thrombotic); using a 2 x 2 factorial design. The primary outcome for colchicine vs. control is the composite of hospitalization or death. The primary outcome for ASA vs. control is the composite of hospitalization, death, or major thrombosis [myocardial infarction(MI), stroke, acute limb ischemia(ALI), or pulmonary embolism (PE)]. For inpatients, in symptomatic patients who are COVID-19 positive and who are hospitalized: colchicine is compared with control (anti-inflammatory), and the combination of ASA and rivaroxaban is compared with control (anti-thrombotic); using a 2 x 2 factorial design. The primary outcome for colchicine vs. control is the composite of high flow oxygen, mechanical ventilation, or death. The primary outcome for the combination of ASA and rivaroxaban vs. control is the composite of high flow oxygen, mechanical ventilation, death, or major thrombosis (MI, stroke, ALI, or PI). *The Inpatient study previously also included a comparison of Interferon-β with control in a 2x2x2 design. The Interferon-β arm was closed to recruitment in November 2020. ;

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• Severe Acute Respiratory Syndrome

• NCT number: NCT04324463
• Study type: Interventional
• Source: Population Health Research Institute
• Status: Completed
• Phase: Phase 3
• Start date: April 21, 2020
• Completion date: December 30, 2022