Table 3

Ongoing RCTs on role of anticoagulation in COVID-19

NameIdentifierLocationType of studyActive comparatorIntervention/ treatment armPrimary outcomePhase of trial
Anticoagulation in patients suffering from COVID-19 (the ANTI-CO Trial)NCT04445935Hamad Medical Corporation, Qatar, DohaTriple-blinded RCTStandard anticoagulation with LMWH/UFHIntravenous bivalirudin according to the institutional HIT protocol.P/F ratio (time frame: 3 days of intervention).4
Anticoagulation in critically ill patients with COVID-19 (the IMPACT Trial)NCT04406389Weill Cornell Medicine New York, USAOpen-labelled RCTIntermediate dose prophylaxis drug: enoxaparin, UFH, fondaparinuxTherapeutic dose anticoagulation drug: enoxaparin, UFH, fondaparinux, argatroban.30-Day mortality.4
Coagulopathy of COVID-19: a pragmatic RCT of therapeutic anticoagulation vs standard careNCT04362085St. Michael's Hospital, Toronto, CanadaTwo arm, parallel, pragmatic, multicentre, open-label RCTStandard Care LMWH, UFH fondaparinux at thromboprophylactic doses for acutely ill hospitalised medical patientsTherapeutic anticoagulation LMWH or UFH (high-dose nomogram) will be administered until discharged from hospital, 28 days or death.ICU admission, non-invasive positive pressure ventilation, invasive mechanical ventilation, all-cause death (yes/no) up to 28 days.3
FREEDOM COVID-19 anticoagulation strategyNCT04512079· Icahn School of Medicine at Mount Sinai New York, New York, USAProspective, multicentre, open label, randomised controlled comparative safety and effectiveness trial1. Prophylactic enoxaparin. 2. Full-dose enoxaparinApixaban (5 mg every 12 hours; 2.5 mg every 12 hours for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL).Time to first events Number of in-hospital rate of BARC 3 or 5 (time frame for both: 30 days).4
Intermediate or prophylactic-dose anticoagulation for venous or arterial TE in severe COVID-19NCT04367831Columbia University Medical Center New York, New York, USASingle-blind parallel RCTProphylactic dose anticoagulation with enoxaparin, UFH.Intermediate-dose anticoagulation with UFH infusion or enoxaparin intermediate dose.Total number of patients with clinically relevant venous or arterial thrombotic events in ICU (time frame: discharge from ICU or 30 days).4
Full anticoagulation vs prophylaxis in COVID-19: COALIZAO ACTION TrialNCT04394377Bahia, BrazilSingle-blinded parallel, multicentric RCTUsual standard of care with prophylactic dose of enoxaparinRivaroxaban 20 mg/day followed by enoxaparin/UFH when needed.Mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.4
Tenecteplase in patients with COVID-19NCT04505592Mount Sinai Hospital New York, USAPlacebo-controlled, double-blind, RCTPlacebo controlTenecteplaseNumber of participants free of respiratory failure
Number of occurrences of bleeding (time frame for both: 28 days).
2
Antithrombotics for adults hospitalised With COVID-19 (ACTIV-4)NCT04505774NYU Langone New York, New York, USAMulticentre, adaptive, randomised controlled platform trialProphylactic dose anticoagulation heparin standard of careTherapeutic dose anticoagulation increased dose of heparin above standard of care.21-Day organ support (respiratory or vasopressor) free days.4
Preventing COVID-19 complications with low-dose and high-dose anticoagulationNCT04345848SwitzerlandOpen-label RCTProphylactic doses of enoxaparin or UFH. If in intensive care augmented thromboprophylaxisTherapeutic doses of enoxaparin or intravenous UFH, from admission until the end of hospital stay or clinical recovery.Composite outcome of arterial or venous thrombosis, DIC and all-cause mortality (time frame: 30 days).4
Full-dose heparin vs prophylactic or intermediate dose heparin in high-risk patients with COVID-19NCT04401293New York, USAOpen-label multicentre randomised active control trialProphylactic/intermediate dose LMWH or UFH therapyFull-dose LMWH anticoagulation therapy.Composite outcome of arterial thromboembolic events, VTE events and all-cause mortality at day 30 ± 2 days.3
  • BARC, Bleeding Academic Research Consortium; ICU, intensive care unit; LMWH, low-molecular weight heparin; P/F ratio, PaO2/FiO2 ratio; RCT, randomised control trial; UFH, unfractionated heparin; VTE, venous thromboembolism.