Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial
- Conditions
- Severe Acute Respiratory SyndromeCoronavirus
- Interventions
- Registration Number
- NCT04324463
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6667
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin (ASA) Aspirin Outpatients: 75 to 100 mg once daily for 28 days. Inpatients: 75 to 100 mg once daily for 28 days Rivaroxaban Rivaroxaban Inpatients Only: 2.5 mg twice daily for 28 days. Colchicine Colchicine Outpatients: 0.6 mg twice daily for 3 days, then 0.6 mg once daily for 25 days (total 28 days). Inpatients: 1.2 mg followed by 0.6 mg 2 hours later, then 0.6 mg twice daily for 28 days. (\*Depending on availability, 0.6 mg tablets can be substituted by 0.5 mg tablets for a regimen in outpatients of 0.5 mg twice daily for 3 days, then 0.5 mg once daily for 25 days \[total 28 days\]; and in inpatients of 1.0 mg followed by 0.5 mg 2 hours later, then 0.5 mg twice daily for 28 days). Interferon Beta [This arm is now closed to recruitment] Interferon-Beta Inpatients Only: 0.25 mg by subcutaneous injection on days 1, 3, 5 \& 7
- Primary Outcome Measures
Name Time Method Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of hospitalization, death or major thrombosis (MI, stroke, ALI, or PE) 45 days post randomization Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death 45 days post randomization Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death 45 days post randomization Inpatient trial - Aspirin and Rivaroxaban vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, death or major thrombosis (MI, stroke, ALI, or PE) 45 days post randomization
- Secondary Outcome Measures
Name Time Method Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT) 45 days post randomization Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death 45 days post randomization Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death 45 days post randomization Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT) 45 days post randomization
Trial Locations
- Locations (66)
Niagara Health System-St. Catharine's
🇨🇦St. Catharines, Ontario, Canada
Santa Casa de Votuporanga
🇧🇷Votuporanga, Sao Paulo, Brazil
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Hospital Universitario Prof. Dr. Horacio Carlos Panepucci da Universidade Federal de Sao Carlos (HU-UFSCar)
🇧🇷São Carlos, SP, Brazil
Ubermed Serviços em Saúde Eireli - Hospital São Domingos
🇧🇷Uberaba, MG, Brazil
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Toronto Western Hospital Family Health Team
🇨🇦Toronto, Ontario, Canada
Woodstock Hospital
🇨🇦Woodstock, Ontario, Canada
Instituto de Neumologico del Oriente
🇨🇴Bucaramanga, Santander, Colombia
Hospital General Pablo Arturo Suarez
🇪🇨Quito, Pichincha, Ecuador
Sahid Gangalal National Heart Center
🇳🇵Kathmandu, Bagmati, Nepal
Tver State Medical University
🇷🇺Tver, Tver Oblast, Russian Federation
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
Hospital Universitario Julio Muller
🇧🇷Cuiabá, Mount, Brazil
Hospital Alemão Oswaldo Cruz
🇧🇷São Paulo, SP, Brazil
Hospital de Clínicas da Universidade Federal de Uberlândia
🇧🇷Uberlândia, MG, Brazil
Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini
🇧🇷Bento Goncalves, Rio Grande Do Sul, Brazil
Halton Healthcare/Oakville Trafalgar Memorial Hospital
🇨🇦Oakville, Ontario, Canada
Windsor Regional Hospital
🇨🇦Windsor, Ontario, Canada
Clinica de la Costa LTDA
🇨🇴Barranquilla, Atlantico, Colombia
Oncoambato
🇪🇨Ambato, Tungurahua, Ecuador
National Hepatology and Tropical Medicine Research Institute
🇪🇬Cairo, Egypt
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
Rostov State Medical University
🇷🇺Rostov-on-Don, Russian Federation
TASK Eden
🇿🇦George, Western Cape, South Africa
SRM Medical College Hospital & Research Center
🇮🇳Chengalpattu, Tamil Nadu, India
Abbasia Fever Hospital
🇪🇬Cairo, Egypt
Koshi Zonal Hospital
🇳🇵Biratnagar, Province No. 1, Nepal
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada
Biomelab SAS
🇨🇴Barranquilla, Atlantico, Colombia
AIG Hospital
🇮🇳Hyderabad, Telangana, India
National Medical Research Center for Therapy and Preventive Medicine
🇷🇺Moscow, Russian Federation
Sanjeevan Hospital
🇮🇳Pune, Maharashtra, India
St. John's Medical College and Hospital
🇮🇳Bangalore, Karnataka, India
Central City Clinical Hospital No. 24
🇷🇺Yekaterinburg, Sverdlovsk Region, Russian Federation
Unicormed
🇪🇨Guayaquil, Guayas, Ecuador
Bharathi Hospital and Research Center
🇮🇳Pune, Maharashtra, India
Abbasia Chest Hospital
🇪🇬Cairo, Egypt
Province Hospital, Karnali Province
🇳🇵Surkhet, Karnali, Nepal
Mechi Zonal Hospital
🇳🇵Bhadrapur, Province No. 1, Nepal
Sidhu Hospital Pvt.Ltd
🇮🇳Doraha, Punjab, India
CIUSSS de L'est-de-l'ile de Montreal, Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Chitwan Medical College
🇳🇵Bharatpur-10, Bagmati, Nepal
Voronezh State Medical University named after N.N. Burdenko
🇷🇺Voronezh, Voronezh Region, Russian Federation
Thumbay Hospital Dubai
🇦🇪Dubai, United Arab Emirates
Hospital Enrique Garces
🇪🇨Quito, Pichincha, Ecuador
Giza Chest Hospital
🇪🇬Giza, Cairo, Egypt
Fayoum University Hospital
🇪🇬Fayoum, Egypt
Altai Regional Center for Medical Prevention
🇷🇺Barnaul, Russian Federation
Hatta Hospital
🇦🇪Hatta, Dubai, United Arab Emirates
Rashid Hospital, Dubai Health Authority
🇦🇪Dubai, United Arab Emirates
Hospital de Especialidades Eugenio Espejo
🇪🇨Quito, Pichincha, Ecuador
State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg"
🇷🇺Ekaterinburg, Sverdlovsk Region, Russian Federation
City Clinical Hospital No. 3
🇷🇺Nizhny Novgorod, Russian Federation
CardiAI Inc.
🇨🇦Calgary, Alberta, Canada
KIMS
🇮🇳Secunderabad, Telangana, India
Tabba Heart Institute
🇵🇰Karachi, Sindh, Pakistan
Philippine General Hospital
🇵🇭Manila, Metro Manila, Philippines
City Clinical Hospital No. 15 named after O.M. Filatova
🇷🇺Moscow, Russian Federation
Tiervlei Trial Centre
🇿🇦Cape Town, Western Cape, South Africa
University of Cape Town- Groote Schuur Hospital
🇿🇦Cape Town, Western Cape, South Africa