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

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Collaborator: Bayer
• Treatments: Aspirin; Chloroquine; Chloroquine diphosphate; Colchicine; Interferon-beta; Interferons; Rivaroxaban

Criteria

Outpatient trial:

Inclusion criteria:

1. Symptomatic and laboratory-confirmed diagnosis of COVID-19.

2. Age ≥18 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.