ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
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.
Drug: Colchicine
oral medication
Drug: Interferon-Beta
subcutaneous injection
Drug: Aspirin
oral medication
Drug: Rivaroxaban
oral medication
Outpatient trial:
Inclusion criteria:
1. Symptomatic and laboratory-confirmed diagnosis of COVID-19.
2. Age ≥ 30 years.
3. High risk: either age ≥70 or one of the following: male; obesity (BMI ≥30); chronic
cardiovascular, respiratory or renal disease; active cancer; diabetes.
4. Within 7 days (ideally 72 hours) of diagnosis, or worsening clinically.
Exclusion criteria:
1. General: advanced kidney disease; advanced liver disease; pregnancy (known or
potential) or lactation.
2. Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil,
HIV protease inhibitor, azole antifungal, or macrolide antibiotic (except
azithromycin).
3. ASA: allergy; high risk of bleeding, current or planned use of other anti-thrombotic
drugs (e.g., P2Y12 inhibitors, direct oral anticoagulants, vitamin K antagonists,
heparins)
Inpatient trial:
Inclusion criteria:
1. Symptomatic and laboratory-confirmed diagnosis of COVID-19.
2. Age ≥18 years.
3. Within 72 hours (ideally 24 hours) of admission, or worsening clinically.
Exclusion criteria:
1. General: advanced kidney disease; advanced liver disease, pregnancy (known or
potential) or lactation, already ventilated for >72 hours.
2. Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil,
HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except
azithromycin).
3. ASA and rivaroxaban: allergy; high risk of bleeding; estimated GFR <15 ml/min; current
or planned use of P2Y12 inhibitors or therapeutic doses of anticoagulants* (e.g.,
direct oral anticoagulants, vitamin K antagonists, heparin, LMWH), current or planned
use of strong inhibitors of both CYP 3A4 and P-gp (e.g., lopinavir/ritonavir,
carbamazepine, ketoconazole). *Note that prophylactic doses of anticoagulants can be
used in patients who are randomized to control.
Hospital Adventista de Manaus
Manaus, Amazonas, Brazil
Prodal Saude S/A
Salvador, BA, Brazil
Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes)
Vitoria, ES, Brazil
Ubermed Serviços em Saúde Eireli - Hospital São Domingos
Uberaba, MG, Brazil
Hospital de Clínicas da Universidade Federal de Uberlândia
Uberlândia, MG, Brazil
Hospital Universitario Julio Muller
Cuiabá, Mount, Brazil
Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini
Bento Goncalves, Rio Grande Do Sul, Brazil
Santa Casa de Votuporanga
Votuporanga, Sao Paulo, Brazil
Hospital Universitario Prof. Dr. Horacio Carlos Panepucci da Universidade Federal de Sao Carlos (HU-UFSCar)
São Carlos, SP, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, SP, Brazil
CardiAI Inc.
Calgary, Alberta, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Halton Healthcare/Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada
Niagara Health System-St. Catharine's
St. Catharines, Ontario, Canada
Toronto Western Hospital Family Health Team
Toronto, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Woodstock Hospital
Woodstock, Ontario, Canada
CIUSSS de L'est-de-l'ile de Montreal, Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec, Canada
Biomelab SAS
Barranquilla, Atlantico, Colombia
Clinica de la Costa LTDA
Barranquilla, Atlantico, Colombia
Instituto de Neumologico del Oriente
Bucaramanga, Santander, Colombia
Unicormed
Guayaquil, Guayas, Ecuador
Hospital de Especialidades Eugenio Espejo
Quito, Pichincha, Ecuador
Hospital Enrique Garces
Quito, Pichincha, Ecuador
Hospital General Pablo Arturo Suarez
Quito, Pichincha, Ecuador
Oncoambato
Ambato, Tungurahua, Ecuador
Giza Chest Hospital
Giza, Cairo, Egypt
Abbasia Chest Hospital
Cairo, Egypt
Abbasia Fever Hospital
Cairo, Egypt
National Hepatology and Tropical Medicine Research Institute
Cairo, Egypt
Fayoum University Hospital
Fayoum, Egypt
St. John's Medical College and Hospital
Bangalore, Karnataka, India
Bharathi Hospital and Research Center
Pune, Maharashtra, India
Sanjeevan Hospital
Pune, Maharashtra, India
Sidhu Hospital Pvt.Ltd
Doraha, Punjab, India
SRM Medical College Hospital & Research Center
Chengalpattu, Tamil Nadu, India
AIG Hospital
Hyderabad, Telangana, India
KIMS
Secunderabad, Telangana, India
Chitwan Medical College
Bharatpur-10, Bagmati, Nepal
Sahid Gangalal National Heart Center
Kathmandu, Bagmati, Nepal
Province Hospital, Karnali Province
Surkhet, Karnali, Nepal
Mechi Zonal Hospital
Bhadrapur, Province No. 1, Nepal
Koshi Zonal Hospital
Biratnagar, Province No. 1, Nepal
B.P. Koirala Institute of Health Sciences
Kathmandu, Province No.1, Nepal
Aga Khan University Hospital
Karachi, Sindh, Pakistan
Jinnah Postgraduate Medical Center
Karachi, Sindh, Pakistan
Tabba Heart Institute
Karachi, Sindh, Pakistan
Philippine General Hospital
Manila, Metro Manila, Philippines
State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg"
Ekaterinburg, Sverdlovsk Region, Russian Federation
Central City Clinical Hospital No. 24
Yekaterinburg, Sverdlovsk Region, Russian Federation
Tver State Medical University
Tver, Tver Oblast, Russian Federation
Voronezh State Medical University named after N.N. Burdenko
Voronezh, Voronezh Region, Russian Federation
Altai Regional Center for Medical Prevention
Barnaul, Russian Federation
City Clinical Hospital No. 15 named after O.M. Filatova
Moscow, Russian Federation
National Medical Research Center for Therapy and Preventive Medicine
Moscow, Russian Federation
City Clinical Hospital No. 3
Nizhny Novgorod, Russian Federation
Rostov State Medical University
Rostov-on-Don, Russian Federation
Tiervlei Trial Centre
Cape Town, Western Cape, South Africa
University of Cape Town- Groote Schuur Hospital
Cape Town, Western Cape, South Africa
TASK Eden
George, Western Cape, South Africa
Hatta Hospital
Hatta, Dubai, United Arab Emirates
Rashid Hospital, Dubai Health Authority
Dubai, United Arab Emirates
Thumbay Hospital Dubai
Dubai, United Arab Emirates