Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial (ACTCOVID19)
Coronavirus, Severe Acute Respiratory Syndrome
About this trial
This is an interventional treatment trial for Coronavirus focused on measuring COVID-19, coronavirus, interferon, colchicine, aspirin, rivaroxaban, anti-inflammatory, antithrombotic, anti-viral
Eligibility Criteria
Outpatient trial:
Inclusion criteria:
- Symptomatic and laboratory-confirmed diagnosis of COVID-19.
- Age ≥ 30 years.
- High risk: either age ≥70 or one of the following: male; obesity (BMI ≥30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes.
- Within 7 days (ideally 72 hours) of diagnosis, or worsening clinically.
Exclusion criteria:
- General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation.
- Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitor, azole antifungal, or macrolide antibiotic (except azithromycin).
- 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:
- Symptomatic and laboratory-confirmed diagnosis of COVID-19.
- Age ≥18 years.
- Within 72 hours (ideally 24 hours) of admission, or worsening clinically.
Exclusion criteria:
- General: advanced kidney disease; advanced liver disease, pregnancy (known or potential) or lactation, already ventilated for >72 hours.
- Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin).
- 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.
Sites / Locations
- Hospital Adventista de Manaus
- Prodal Saude S/A
- Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes)
- Ubermed Serviços em Saúde Eireli - Hospital São Domingos
- Hospital de Clínicas da Universidade Federal de Uberlândia
- Hospital Universitario Julio Muller
- Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini
- Santa Casa de Votuporanga
- Hospital Universitario Prof. Dr. Horacio Carlos Panepucci da Universidade Federal de Sao Carlos (HU-UFSCar)
- Hospital Alemão Oswaldo Cruz
- CardiAI Inc.
- Hamilton Health Sciences
- London Health Sciences Centre
- Southlake Regional Health Centre
- Halton Healthcare/Oakville Trafalgar Memorial Hospital
- Niagara Health System-St. Catharine's
- Toronto Western Hospital Family Health Team
- Windsor Regional Hospital
- Woodstock Hospital
- CIUSSS de L'est-de-l'ile de Montreal, Hopital Maisonneuve-Rosemont
- Centre Hospitalier de l'Université de Montréal (CHUM)
- Biomelab SAS
- Clinica de la Costa LTDA
- Instituto de Neumologico del Oriente
- Unicormed
- Hospital de Especialidades Eugenio Espejo
- Hospital Enrique Garces
- Hospital General Pablo Arturo Suarez
- Oncoambato
- Giza Chest Hospital
- Abbasia Chest Hospital
- Abbasia Fever Hospital
- National Hepatology and Tropical Medicine Research Institute
- Fayoum University Hospital
- St. John's Medical College and Hospital
- Bharathi Hospital and Research Center
- Sanjeevan Hospital
- Sidhu Hospital Pvt.Ltd
- SRM Medical College Hospital & Research Center
- AIG Hospital
- KIMS
- Chitwan Medical College
- Sahid Gangalal National Heart Center
- Province Hospital, Karnali Province
- Mechi Zonal Hospital
- Koshi Zonal Hospital
- B.P. Koirala Institute of Health Sciences
- Aga Khan University Hospital
- Jinnah Postgraduate Medical Center
- Tabba Heart Institute
- Philippine General Hospital
- State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg"
- Central City Clinical Hospital No. 24
- Tver State Medical University
- Voronezh State Medical University named after N.N. Burdenko
- Altai Regional Center for Medical Prevention
- City Clinical Hospital No. 15 named after O.M. Filatova
- National Medical Research Center for Therapy and Preventive Medicine
- City Clinical Hospital No. 3
- Rostov State Medical University
- Tiervlei Trial Centre
- University of Cape Town- Groote Schuur Hospital
- TASK Eden
- Hatta Hospital
- Rashid Hospital, Dubai Health Authority
- Thumbay Hospital Dubai
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
No Intervention
Colchicine
Interferon Beta [This arm is now closed to recruitment]
Aspirin (ASA)
Rivaroxaban
Usual Care (Control)
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).
Inpatients Only: 0.25 mg by subcutaneous injection on days 1, 3, 5 & 7
Outpatients: 75 to 100 mg once daily for 28 days. Inpatients: 75 to 100 mg once daily for 28 days
Inpatients Only: 2.5 mg twice daily for 28 days.
Outpatients and Inpatients: No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.