Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial
NCT ID: NCT04324463
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
6667 participants
INTERVENTIONAL
2020-04-21
2022-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Colchicine
oral medication
Interferon Beta [This arm is now closed to recruitment]
Inpatients Only:
0.25 mg by subcutaneous injection on days 1, 3, 5 \& 7
Interferon-Beta
subcutaneous injection
Aspirin (ASA)
Outpatients:
75 to 100 mg once daily for 28 days.
Inpatients:
75 to 100 mg once daily for 28 days
Aspirin
oral medication
Rivaroxaban
Inpatients Only:
2.5 mg twice daily for 28 days.
Rivaroxaban
oral medication
Usual Care (Control)
Outpatients and Inpatients: No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.
No interventions assigned to this group
Interventions
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Colchicine
oral medication
Interferon-Beta
subcutaneous injection
Aspirin
oral medication
Rivaroxaban
oral medication
Eligibility Criteria
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Inclusion Criteria
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.
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
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:
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.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Richard Whitlock, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Emilie Belley-Cote, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
John Eikelboom, MBBS MSc
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Locations
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Hospital Adventista de Manaus
Manaus, Amazonas, Brazil
Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes)
Vitória, Espírito Santo, Brazil
Prodal Saude S/A
Salvador, Estado de Bahia, Brazil
Ubermed Serviços em Saúde Eireli - Hospital São Domingos
Uberaba, Minas Gerais, Brazil
Hospital de Clínicas da Universidade Federal de Uberlândia
Uberlândia, Minas Gerais, Brazil
Hospital Universitario Julio Muller
Cuiabá, Mount, Brazil
Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil
Hospital Universitario Prof. Dr. Horacio Carlos Panepucci da Universidade Federal de Sao Carlos (HU-UFSCar)
São Carlos, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Santa Casa de Votuporanga
Votuporanga, São Paulo, 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
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
CIUSSS de L'est-de-l'ile de Montreal, Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Biomelab SAS
Barranquilla, Atlántico, Colombia
Clinica de la Costa LTDA
Barranquilla, Atlántico, Colombia
Instituto de Neumologico del Oriente
Bucaramanga, Santander Department, 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 Province, Ecuador
Giza Chest Hospital
Giza, Cairo Governorate, Egypt
Fayoum University Hospital
Al Fayyum, , Egypt
Abbasia Chest Hospital
Cairo, , Egypt
Abbasia Fever Hospital
Cairo, , Egypt
National Hepatology and Tropical Medicine Research Institute
Cairo, , 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
Dorāha, 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, National Capital Region, Philippines
Central City Clinical Hospital No. 24
Yekaterinburg, Sverdlovsk Oblast, Russia
State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg"
Yekaterinburg, Sverdlovsk Oblast, Russia
Tver State Medical University
Tver', Tver Oblast, Russia
Voronezh State Medical University named after N.N. Burdenko
Voronezh, Voronezh Oblast, Russia
Altai Regional Center for Medical Prevention
Barnaul, , Russia
City Clinical Hospital No. 15 named after O.M. Filatova
Moscow, , Russia
National Medical Research Center for Therapy and Preventive Medicine
Moscow, , Russia
City Clinical Hospital No. 3
Nizhny Novgorod, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
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
Countries
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References
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Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
Eikelboom JW, Jolly SS, Belley-Cote EP, Whitlock RP, Rangarajan S, Xu L, Heenan L, Bangdiwala SI, Luz Diaz M, Diaz R, Yusufali A, Kumar Sharma S, Tarhuni WM, Hassany M, Avezum A, Harper W, Wasserman S, Almas A, Drapkina O, Felix C, Lopes RD, Berwanger O, Lopez-Jaramillo P, Anand SS, Bosch J, Choudhri S, Farkouh ME, Loeb M, Yusuf S. Colchicine and the combination of rivaroxaban and aspirin in patients hospitalised with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial. Lancet Respir Med. 2022 Dec;10(12):1169-1177. doi: 10.1016/S2213-2600(22)00298-3. Epub 2022 Oct 10.
Eikelboom JW, Jolly SS, Belley-Cote EP, Whitlock RP, Rangarajan S, Xu L, Heenan L, Bangdiwala SI, Tarhuni WM, Hassany M, Kontsevaya A, Harper W, Sharma SK, Lopez-Jaramillo P, Dans AL, Palileo-Villanueva LM, Avezum A, Pais P, Xavier D, Felix C, Yusufali A, Lopes RD, Berwanger O, Ali Z, Wasserman S, Anand SS, Bosch J, Choudhri S, Farkouh ME, Loeb M, Yusuf S. Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial. Lancet Respir Med. 2022 Dec;10(12):1160-1168. doi: 10.1016/S2213-2600(22)00299-5. Epub 2022 Oct 10.
Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
Other Identifiers
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PHRI.ACT.COVID19
Identifier Type: -
Identifier Source: org_study_id
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