Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial

Coronavirus Clinical Trial

— ACTCOVID19  

Official title:

Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324463
• Other study ID #: PHRI.ACT.COVID19
• Status: Completed
• Phase: Phase 3
• Start date: April 21, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

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 information / eligibility

• Status: Completed
• Enrollment: 6667
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Colchicine
oral medication
• Interferon-Beta
subcutaneous injection
• Aspirin
oral medication
• Rivaroxaban
oral medication

Locations

Country	Name	City	State
Brazil	Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini	Bento Goncalves	Rio Grande Do Sul
Brazil	Hospital Universitario Julio Muller	Cuiabá	Mount
Brazil	Hospital Adventista de Manaus	Manaus	Amazonas
Brazil	Prodal Saude S/A	Salvador	BA
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	Ubermed Serviços em Saúde Eireli - Hospital São Domingos	Uberaba	MG
Brazil	Hospital de Clínicas da Universidade Federal de Uberlândia	Uberlândia	MG
Brazil	Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes)	Vitoria	ES
Brazil	Santa Casa de Votuporanga	Votuporanga	Sao Paulo
Canada	CardiAI Inc.	Calgary	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	London Health Sciences Centre	London	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	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
Colombia	Biomelab SAS	Barranquilla	Atlantico
Colombia	Clinica de la Costa LTDA	Barranquilla	Atlantico
Colombia	Instituto de Neumologico del Oriente	Bucaramanga	Santander
Ecuador	Oncoambato	Ambato	Tungurahua
Ecuador	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
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	Giza Chest Hospital	Giza	Cairo
India	St. John's Medical College and Hospital	Bangalore	Karnataka
India	SRM Medical College Hospital & Research Center	Chengalpattu	Tamil Nadu
India	Sidhu Hospital Pvt.Ltd	Doraha	Punjab
India	AIG Hospital	Hyderabad	Telangana
India	Bharathi Hospital and Research Center	Pune	Maharashtra
India	Sanjeevan Hospital	Pune	Maharashtra
India	KIMS	Secunderabad	Telangana
Nepal	Mechi Zonal Hospital	Bhadrapur	Province No. 1
Nepal	Chitwan Medical College	Bharatpur-10	Bagmati
Nepal	Koshi Zonal Hospital	Biratnagar	Province No. 1
Nepal	B.P. Koirala Institute of Health Sciences	Kathmandu	Province No.1
Nepal	Sahid Gangalal National Heart Center	Kathmandu	Bagmati
Nepal	Province Hospital, Karnali Province	Surkhet	Karnali
Pakistan	Aga Khan University Hospital	Karachi	Sindh
Pakistan	Jinnah Postgraduate Medical Center	Karachi	Sindh
Pakistan	Tabba Heart Institute	Karachi	Sindh
Philippines	Philippine General Hospital	Manila	Metro Manila
Russian Federation	Altai Regional Center for Medical Prevention	Barnaul
Russian Federation	State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg"	Ekaterinburg	Sverdlovsk Region
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	Tver State Medical University	Tver	Tver Oblast
Russian Federation	Voronezh State Medical University named after N.N. Burdenko	Voronezh	Voronezh Region
Russian Federation	Central City Clinical Hospital No. 24	Yekaterinburg	Sverdlovsk Region
South Africa	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
United Arab Emirates	Rashid Hospital, Dubai Health Authority	Dubai
United Arab Emirates	Thumbay Hospital Dubai	Dubai
United Arab Emirates	Hatta Hospital	Hatta	Dubai

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Bayer

Countries where clinical trial is conducted

Brazil,  Canada,  Colombia,  Ecuador,  Egypt,  India,  Nepal,  Pakistan,  Philippines,  Russian Federation,  South Africa,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death		45 days post randomization
Primary	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
Primary	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
Primary	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	Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)		45 days post randomization
Secondary	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
Secondary	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
Secondary	Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)		45 days post randomization