Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT05065827 - Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
Recruiting NCT05359770 - Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19 N/A
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Not yet recruiting NCT06025812 - Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) N/A
Recruiting NCT05289115 - Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS N/A
Completed NCT04953078 - A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19 Phase 1
Completed NCT04779138 - Increasing Vaccine Uptake in Underresourced Public Housing Areas N/A
Not yet recruiting NCT05868239 - Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study N/A
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04572399 - UVA Light Device to Treat COVID-19 N/A
Recruiting NCT04610567 - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19) Phase 1/Phase 2
Recruiting NCT04772170 - Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Recruiting NCT04581954 - Inflammatory Signal Inhibitors for COVID-19 (MATIS) Phase 1/Phase 2
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Completed NCT05572840 - Wear Your Mask, Wash Your Hands, Don't Get COVID-19 N/A
Withdrawn NCT04838847 - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Phase 3
Terminated NCT04371978 - Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19 Phase 3