Status:
COMPLETED
Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Bayer
Conditions:
Coronavirus
Severe Acute Respiratory Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
6667 Patients enrolled
Trial Details
Trial ID
NCT04324463
Start Date
April 21 2020
End Date
December 30 2022
Last Update
January 11 2024
Active Locations (66)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Adventista de Manaus
Manaus, Amazonas, Brazil
2
Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes)
Vitória, Espírito Santo, Brazil
3
Prodal Saude S/A
Salvador, Estado de Bahia, Brazil
4
Ubermed Serviços em Saúde Eireli - Hospital São Domingos
Uberaba, Minas Gerais, Brazil