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CoronavirusPhase 3ACTCOVID19NCT04324463

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

A Phase 3 study testing Colchicine, Interferon-Beta and Aspirin in people with Coronavirus and Severe Acute Respiratory Syndrome, run by Population Health Research Institute at 66 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Colchicine, Interferon-Beta and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,667 participants
Where
66 sitesin 12 countries
Study dates
21 Apr 2020to 30 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Symptomatic and laboratory-confirmed diagnosis of COVID-19.
  • Age ≥18 years.
  • Within 72 hours (ideally 24 hours) of admission, or worsening clinically.

Who cannot join

  • 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:
  • 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.

Trial locations and contacts

66 sites in 12 countries.

66 sites in 12 countries

Canada11 sites

  • CardiAI Inc.

    Calgary, Alberta

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L2X2

  • London Health Sciences Centre

    London, Ontario

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec

  • CIUSSS de L'est-de-l'ile de Montreal, Hopital Maisonneuve-Rosemont

    Montreal, Quebec

  • Southlake Regional Health Centre

    Newmarket, Ontario

  • Halton Healthcare/Oakville Trafalgar Memorial Hospital

    Oakville, Ontario

  • Niagara Health System-St. Catharine's

    St. Catharines, Ontario

  • Toronto Western Hospital Family Health Team

    Toronto, Ontario

  • Windsor Regional Hospital

    Windsor, Ontario

  • Woodstock Hospital

    Woodstock, Ontario

Other trials in Canada

Brazil10 sites

  • Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini

    Bento Gonçalves, Rio Grande do Sul

  • Hospital Universitario Julio Muller

    Cuiabá, Mount

  • Hospital Adventista de Manaus

    Manaus, Amazonas

  • Prodal Saude S/A

    Salvador, Estado de Bahia

  • Hospital Universitario Prof. Dr. Horacio Carlos Panepucci da Universidade Federal de Sao Carlos (HU-UFSCar)

    São Carlos, São Paulo

  • Hospital Alemão Oswaldo Cruz

    São Paulo, São Paulo

  • Ubermed Serviços em Saúde Eireli - Hospital São Domingos

    Uberaba, Minas Gerais

  • Hospital de Clínicas da Universidade Federal de Uberlândia

    Uberlândia, Minas Gerais

  • Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes)

    Vitória, Espírito Santo

  • Santa Casa de Votuporanga

    Votuporanga, São Paulo

Other trials in Brazil

Russia9 sites

  • Altai Regional Center for Medical Prevention

    Barnaul

  • City Clinical Hospital No. 15 named after O.M. Filatova

    Moscow

  • National Medical Research Center for Therapy and Preventive Medicine

    Moscow

  • City Clinical Hospital No. 3

    Nizhny Novgorod

  • Rostov State Medical University

    Rostov-on-Don

  • Tver State Medical University

    Tver', Tver Oblast

  • Voronezh State Medical University named after N.N. Burdenko

    Voronezh, Voronezh Oblast

  • Central City Clinical Hospital No. 24

    Yekaterinburg, Sverdlovsk Oblast

  • State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg"

    Yekaterinburg, Sverdlovsk Oblast

Other trials in Russia

India7 sites

  • St. John's Medical College and Hospital

    Bangalore, Karnataka

  • SRM Medical College Hospital & Research Center

    Chengalpattu, Tamil Nadu

  • Sidhu Hospital Pvt.Ltd

    Dorāha, Punjab

  • AIG Hospital

    Hyderabad, Telangana

  • Bharathi Hospital and Research Center

    Pune, Maharashtra

  • Sanjeevan Hospital

    Pune, Maharashtra

  • KIMS

    Secunderabad, Telangana

Other trials in India

Nepal6 sites

  • Mechi Zonal Hospital

    Bhadrapur, Province No. 1

  • Chitwan Medical College

    Bharatpur-10, Bagmati

  • Koshi Zonal Hospital

    Biratnagar, Province No. 1

  • Sahid Gangalal National Heart Center

    Kathmandu, Bagmati

  • B.P. Koirala Institute of Health Sciences

    Kathmandu, Province No.1

  • Province Hospital, Karnali Province

    Surkhet, Karnali

Other trials in Nepal

Ecuador5 sites

  • Oncoambato

    Ambato, Tungurahua Province

  • Unicormed

    Guayaquil, Guayas

  • Hospital de Especialidades Eugenio Espejo

    Quito, Pichincha

  • Hospital Enrique Garces

    Quito, Pichincha

  • Hospital General Pablo Arturo Suarez

    Quito, Pichincha

Other trials in Ecuador

Egypt5 sites

  • Fayoum University Hospital

    Al Fayyum

  • Abbasia Chest Hospital

    Cairo

  • Abbasia Fever Hospital

    Cairo

  • National Hepatology and Tropical Medicine Research Institute

    Cairo

  • Giza Chest Hospital

    Giza, Cairo Governorate

Other trials in Egypt

Colombia3 sites

  • Biomelab SAS

    Barranquilla, Atlántico

  • Clinica de la Costa LTDA

    Barranquilla, Atlántico

  • Instituto de Neumologico del Oriente

    Bucaramanga, Santander Department

Other trials in Colombia

Pakistan3 sites

  • Aga Khan University Hospital

    Karachi, Sindh

  • Jinnah Postgraduate Medical Center

    Karachi, Sindh

  • Tabba Heart Institute

    Karachi, Sindh

Other trials in Pakistan

South Africa3 sites

  • Tiervlei Trial Centre

    Cape Town, Western Cape

  • University of Cape Town- Groote Schuur Hospital

    Cape Town, Western Cape

  • TASK Eden

    George, Western Cape

Other trials in South Africa

United Arab Emirates3 sites

  • Rashid Hospital, Dubai Health Authority

    Dubai

  • Thumbay Hospital Dubai

    Dubai

  • Hatta Hospital

    Hatta, Dubai

Other trials in United Arab Emirates

Philippines1 site

  • Philippine General Hospital

    Manila, National Capital Region

Other trials in Philippines

About this study

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

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

Read the 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.

Being tested
Colchicine, Interferon-Beta, Aspirin, Rivaroxaban
Keywords
COVID-19, coronavirus, interferon, colchicine, aspirin, rivaroxaban, anti-inflammatory, antithrombotic, anti-viral
Medical subject headings
Coronavirus Infections, Severe Acute Respiratory Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    oral medication

  • Interferon-BetaDrug

    subcutaneous injection

  • AspirinDrug

    oral medication

  • RivaroxabanDrug

    oral medication

Study groups in NCT04324463
Study groupRoleWhat they receive
ColchicineExperimentalOutpatients: 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).
Receives: Drug: Colchicine
Interferon Beta [This arm is now closed to recruitment]ExperimentalInpatients Only: 0.25 mg by subcutaneous injection on days 1, 3, 5 \& 7
Receives: Drug: Interferon-Beta
Aspirin (ASA)ExperimentalOutpatients: 75 to 100 mg once daily for 28 days. Inpatients: 75 to 100 mg once daily for 28 days
Receives: Drug: Aspirin
RivaroxabanExperimentalInpatients Only: 2.5 mg twice daily for 28 days.
Receives: Drug: Rivaroxaban
Usual Care (Control)No interventionOutpatients and Inpatients: No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death

    Measured: 45 days post randomization

  2. 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)

    Measured: 45 days post randomization

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

    Measured: 45 days post randomization

  4. 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)

    Measured: 45 days post randomization

Secondary outcomes (4)

  1. Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)

    Measured: 45 days post randomization

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

    Measured: 45 days post randomization

  3. Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death

    Measured: 45 days post randomization

  4. Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)

    Measured: 45 days post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start21 Apr 2020
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, parallel group, factorial, randomized controlled trial
Masking
None (open label)
Enrolment
6,667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04324463
Sponsor's protocol ID
PHRI.ACT.COVID19
Acronym
ACTCOVID19
Status last verified
Jan 2024
First submitted
25 Mar 2020
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37489818

  • 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.

    PubMed 36228641

  • 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.

    PubMed 36228639

  • 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.

    PubMed 34658014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine, Interferon-Beta and Aspirin in people with Coronavirus and Severe Acute Respiratory Syndrome, run by Population Health Research Institute at 66 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Canada, Brazil, Russia, India, Nepal and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death (time frame: 45 days post randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04324463, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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