ACT STUDY | CardiAI™

ACT Study

Anti-Coronavirus Therapies to prevent COVID-19 progression trial. This study will evaluate anti-inflammatory and anti-thrombotic therapy to determine whether they prevent clinical progression of COVID-19 in outpatients and inpatients.

Outpatient

Randomization (factorial randomization)

  • Anti-inflammatory: Colchicine vs. control (usual care)
  • Antithrombotic: Acetylsalicylic acid (ASA) vs. control (usual care)

Inclusion

  1. Symptomatic and laboratory-confirmed diagnosis of COVID-19.
  2. Age ≥18 years.
  3. High risk: either age ≥70 or at least 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

  1. General: advanced kidney disease (eGFR  <15 mL/min/1.73m2)*; 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,  systemic azole antifungal, or macrolide   antibiotic (except azithromycin).
  3. ASA: allergy or planned use; high risk of  bleeding, current or planned use of other  anti-thrombotic drugs (e.g., P2Y12  inhibitors, direct oral anticoagulants,   vitamin K antagonists, heparins).

(*Patients >70 years, with known chronic kidney disease, or with a history of diabetes for more than 10 years must have creatinine [eGFR] result available from within 3 months prior to randomization)

Inpatient

RANDOMIZATION (factorial randomizations)

  • Anti-inflammatory: colchicine vs. control (Usual care)
  • Antithrombotic: combination of ASA and rivaroxaban vs. control (Usual care)

Inclusion

  1. Symptomatic and laboratory diagnosis of  COVID-19
  2. Age ≥18 years of age.
  3. Within 72 hours (ideally 24 hours) of   hospital admission, or worsening clinically.

Exclusion

  1. General: advanced kidney disease (eGFR  <15 mL/min/1.73m2), 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 inhibitor,  systemic azole antifungal, or macrolide  antibiotic (except azithromycin).
  3. ASA and rivaroxaban: allergy or planned  use of rivaroxaban; high risk of bleeding;  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 anticoagulant can
be used in patients who are not randomized to the
combination of ASA and rivaroxaban.

(*Patients must have creatinine [eGFR] result available from within 72 hours before randomization).