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

Phase 3

Completed

• Conditions: Severe Acute Respiratory Syndrome; Coronavirus
• Interventions: Drug: Aspirin; Drug: Rivaroxaban; Drug: Colchicine; Drug: Interferon-Beta

• Registration Number: NCT04324463
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Study Start: 2020-04-21
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6667

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin (ASA)	Aspirin	Outpatients: 75 to 100 mg once daily for 28 days. Inpatients: 75 to 100 mg once daily for 28 days
Rivaroxaban	Rivaroxaban	Inpatients Only: 2.5 mg twice daily for 28 days.
Colchicine	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).
Interferon Beta [This arm is now closed to recruitment]	Interferon-Beta	Inpatients Only: 0.25 mg by subcutaneous injection on days 1, 3, 5 \& 7

Primary Outcome Measures

Name	Time	Method
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
Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death	45 days post randomization
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
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 Outcome Measures

Name	Time	Method
Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)	45 days post randomization
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
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
Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)	45 days post randomization

Trial Locations

Locations (66)

Hospital Adventista de Manaus; 🇧🇷 Manaus, Amazonas, Brazil

Prodal Saude S/A; 🇧🇷 Salvador, BA, Brazil

Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes); 🇧🇷 Vitoria, ES, Brazil

Ubermed Serviços em Saúde Eireli - Hospital São Domingos; 🇧🇷 Uberaba, MG, Brazil

Hospital de Clínicas da Universidade Federal de Uberlândia; 🇧🇷 Uberlândia, MG, Brazil

Hospital Universitario Julio Muller; 🇧🇷 Cuiabá, Mount, Brazil

Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini; 🇧🇷 Bento Goncalves, Rio Grande Do Sul, Brazil

Santa Casa de Votuporanga; 🇧🇷 Votuporanga, Sao Paulo, 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

Scroll for more (56 remaining)