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Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial (ACTCOVID19)

Primary Purpose

Coronavirus, Severe Acute Respiratory Syndrome

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Colchicine
Interferon-Beta
Aspirin
Rivaroxaban
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Colchicine

Interferon Beta [This arm is now closed to recruitment]

Aspirin (ASA)

Rivaroxaban

Usual Care (Control)

Arm Description

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.

Outcomes

Primary Outcome Measures

Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death
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)
Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death
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)

Secondary Outcome Measures

Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)
Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death
Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death
Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)

Full Information

First Posted
March 25, 2020
Last Updated
August 21, 2023
Sponsor
Population Health Research Institute
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04324463
Brief Title
Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial
Acronym
ACTCOVID19
Official Title
Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Severe Acute Respiratory Syndrome
Keywords
COVID-19, coronavirus, interferon, colchicine, aspirin, rivaroxaban, anti-inflammatory, antithrombotic, anti-viral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label, parallel group, factorial, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Experimental
Arm Description
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).
Arm Title
Interferon Beta [This arm is now closed to recruitment]
Arm Type
Experimental
Arm Description
Inpatients Only: 0.25 mg by subcutaneous injection on days 1, 3, 5 & 7
Arm Title
Aspirin (ASA)
Arm Type
Experimental
Arm Description
Outpatients: 75 to 100 mg once daily for 28 days. Inpatients: 75 to 100 mg once daily for 28 days
Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
Inpatients Only: 2.5 mg twice daily for 28 days.
Arm Title
Usual Care (Control)
Arm Type
No Intervention
Arm Description
Outpatients and Inpatients: No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
oral medication
Intervention Type
Drug
Intervention Name(s)
Interferon-Beta
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
oral medication
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
oral medication
Primary Outcome Measure Information:
Title
Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death
Time Frame
45 days post randomization
Title
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)
Time Frame
45 days post randomization
Title
Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death
Time Frame
45 days post randomization
Title
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)
Time Frame
45 days post randomization
Secondary Outcome Measure Information:
Title
Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)
Time Frame
45 days post randomization
Title
Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death
Time Frame
45 days post randomization
Title
Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death
Time Frame
45 days post randomization
Title
Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)
Time Frame
45 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Whitlock, MD PhD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilie Belley-Cote, MD PhD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Eikelboom, MBBS MSc
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Adventista de Manaus
City
Manaus
State/Province
Amazonas
Country
Brazil
Facility Name
Prodal Saude S/A
City
Salvador
State/Province
BA
Country
Brazil
Facility Name
Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes)
City
Vitoria
State/Province
ES
Country
Brazil
Facility Name
Ubermed Serviços em Saúde Eireli - Hospital São Domingos
City
Uberaba
State/Province
MG
Country
Brazil
Facility Name
Hospital de Clínicas da Universidade Federal de Uberlândia
City
Uberlândia
State/Province
MG
Country
Brazil
Facility Name
Hospital Universitario Julio Muller
City
Cuiabá
State/Province
Mount
Country
Brazil
Facility Name
Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini
City
Bento Goncalves
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Santa Casa de Votuporanga
City
Votuporanga
State/Province
Sao Paulo
Country
Brazil
Facility Name
Hospital Universitario Prof. Dr. Horacio Carlos Panepucci da Universidade Federal de Sao Carlos (HU-UFSCar)
City
São Carlos
State/Province
SP
Country
Brazil
Facility Name
Hospital Alemão Oswaldo Cruz
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
CardiAI Inc.
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Halton Healthcare/Oakville Trafalgar Memorial Hospital
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Niagara Health System-St. Catharine's
City
St. Catharines
State/Province
Ontario
Country
Canada
Facility Name
Toronto Western Hospital Family Health Team
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Windsor Regional Hospital
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Woodstock Hospital
City
Woodstock
State/Province
Ontario
Country
Canada
Facility Name
CIUSSS de L'est-de-l'ile de Montreal, Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Biomelab SAS
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Clinica de la Costa LTDA
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Instituto de Neumologico del Oriente
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Unicormed
City
Guayaquil
State/Province
Guayas
Country
Ecuador
Facility Name
Hospital de Especialidades Eugenio Espejo
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Hospital Enrique Garces
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Hospital General Pablo Arturo Suarez
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Oncoambato
City
Ambato
State/Province
Tungurahua
Country
Ecuador
Facility Name
Giza Chest Hospital
City
Giza
State/Province
Cairo
Country
Egypt
Facility Name
Abbasia Chest Hospital
City
Cairo
Country
Egypt
Facility Name
Abbasia Fever Hospital
City
Cairo
Country
Egypt
Facility Name
National Hepatology and Tropical Medicine Research Institute
City
Cairo
Country
Egypt
Facility Name
Fayoum University Hospital
City
Fayoum
Country
Egypt
Facility Name
St. John's Medical College and Hospital
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Bharathi Hospital and Research Center
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Sanjeevan Hospital
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Sidhu Hospital Pvt.Ltd
City
Doraha
State/Province
Punjab
Country
India
Facility Name
SRM Medical College Hospital & Research Center
City
Chengalpattu
State/Province
Tamil Nadu
Country
India
Facility Name
AIG Hospital
City
Hyderabad
State/Province
Telangana
Country
India
Facility Name
KIMS
City
Secunderabad
State/Province
Telangana
Country
India
Facility Name
Chitwan Medical College
City
Bharatpur-10
State/Province
Bagmati
Country
Nepal
Facility Name
Sahid Gangalal National Heart Center
City
Kathmandu
State/Province
Bagmati
Country
Nepal
Facility Name
Province Hospital, Karnali Province
City
Surkhet
State/Province
Karnali
Country
Nepal
Facility Name
Mechi Zonal Hospital
City
Bhadrapur
State/Province
Province No. 1
Country
Nepal
Facility Name
Koshi Zonal Hospital
City
Biratnagar
State/Province
Province No. 1
Country
Nepal
Facility Name
B.P. Koirala Institute of Health Sciences
City
Kathmandu
State/Province
Province No.1
Country
Nepal
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Jinnah Postgraduate Medical Center
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Tabba Heart Institute
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Philippine General Hospital
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg"
City
Ekaterinburg
State/Province
Sverdlovsk Region
Country
Russian Federation
Facility Name
Central City Clinical Hospital No. 24
City
Yekaterinburg
State/Province
Sverdlovsk Region
Country
Russian Federation
Facility Name
Tver State Medical University
City
Tver
State/Province
Tver Oblast
Country
Russian Federation
Facility Name
Voronezh State Medical University named after N.N. Burdenko
City
Voronezh
State/Province
Voronezh Region
Country
Russian Federation
Facility Name
Altai Regional Center for Medical Prevention
City
Barnaul
Country
Russian Federation
Facility Name
City Clinical Hospital No. 15 named after O.M. Filatova
City
Moscow
Country
Russian Federation
Facility Name
National Medical Research Center for Therapy and Preventive Medicine
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital No. 3
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Tiervlei Trial Centre
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
University of Cape Town- Groote Schuur Hospital
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
TASK Eden
City
George
State/Province
Western Cape
Country
South Africa
Facility Name
Hatta Hospital
City
Hatta
State/Province
Dubai
Country
United Arab Emirates
Facility Name
Rashid Hospital, Dubai Health Authority
City
Dubai
Country
United Arab Emirates
Facility Name
Thumbay Hospital Dubai
City
Dubai
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36228641
Citation
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.
Results Reference
derived
PubMed Identifier
36228639
Citation
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.
Results Reference
derived
PubMed Identifier
34658014
Citation
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.
Results Reference
derived

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

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