TABLE 2.
Clinical studies evaluating mitigation strategies of venous thromboembolism in inpatients with COVID‐19 listed on the clinicaltrials.gov website on December 16, 2021
| ClinicalTrials.gov identifier | Title of study | Question/outcome(s) of interest | Comparator arms | Status (12/16/2021) |
|---|---|---|---|---|
| Outpatient setting (prehospital) | ||||
| NCT04508023 | A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID‐19) Infection (PREVENT‐HD) | Evaluate the safety and efficacy of prophylactic dose of rivaroxaban to reduce thrombotic events, hospitalization, and death in outpatients with symptomatic SARS‐CoV‐2 infection | Prophylactic rivaroxaban (10 mg daily) vs placebo | Recruiting |
| NCT04400799 | Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID‐19 | Age ≥50 y; primary outcome of hospitalization and all‐cause death | Enoxaparin 40 mg daily vs no treatment | Recruiting |
| Moderate‐severe hospitalized patients | ||||
| NCT04416048 | Effect of Anticoagulation Therapy on Clinical Outcomes in COVID‐19 (COVID‐PREVENT) | Rivaroxaban for the prevention of thrombotic events and all‐cause mortality in patients with moderate to severe COVID‐19 | Rivaroxaban 20 mg daily × 7 days or hospital discharge followed by rivaroxaban 10 mg daily for 28 days vs standard of care thromboprophylaxis | Recruiting |
| NCT04505774 | Accelerating COVID‐19 Therapeutic Interventions and Vaccines 4 ACUTE (ACTIV‐4A) | 21‐day organ support–free days. Secondary outcomes include thrombotic events and all‐cause mortality | Therapeutic‐dose anticoagulation vs prophylactic‐dose anticoagulation, vs therapeutic anticoagulation +P2Y12 inhibitor vs prophylactic anticoagulation +P2Y12 inhibitor | Recruiting |
| NCT04373707 | Effectiveness of Weight‐Adjusted Prophylactic Low Molecular Weight Heparin Doses Compared With Lower Fixed Prophylactic Doses to Prevent Venous Thromboembolism in COVID‐2019 (The Multicenter Randomized Controlled Open‐label Trial COVI‐DOSE) | Risk of DVT or PE or VTE‐related death | Standard prophylactic dose LMWH vs weight‐adjusted prophylactic dose LMWH | Recruiting |
| NCT04730856 | Standard vs High Prophylactic Doses or Anticoagulation in Patients With High Risk of Thrombosis Admitted With COVID‐19 Pneumonia (PROTHROMCOVID) | Risk of thrombotic events, use of mechanical ventilation, length of hospitalization, length of ICU stay, overall survival | Tinzaparin 4500 UI/day vs tinzaparin 100 UI/kg/day vs. tinzaparin 175 UI/kg/day | Recruiting |
| NCT04646655 | Enoxaparin at Prophylactic or Therapeutic Doses With Monitoring of Outcomes in Subjects Infected With COVID‐19: a Pilot Study on 300 Cases Enrolled at ASST‐FBF‐Sacco | Mortality rate, respiratory failure, major bleeding; secondary outcome measures include DVT | Enoxaparin prophylactic dose vs enoxaparin therapeutic dose | Recruiting |
| NCT04409834 | A Multicenter, Randomized‐Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically Ill COVID‐19 Patients | Prevention of thrombotic events | Full‐dose anticoagulation+antiplatelet vs full‐dose anticoagulation without antiplatelet vs prophylactic anticoagulation +antiplatelet vs prophylactic anticoagulation without antiplatelet | Recruiting |
| NCT04483960 | Australasian COVID‐19 Trial (ASCOT) ADAptive Platform Trial (ASCOT ADAPT) | All‐cause mortality or new intensive respiratory support or vasopressor/ionotropic support | Standard‐dose thromoboprophylaxis vs intermediate dose thromboprophylaxis vs therapeutic anticoagulation | Recruiting |
| NCT04345848 | Preventing COVID‐19‐associated Thrombosis, Coagulopathy and Mortality With Low‐ and High‐dose Anticoagulation: a Multicentric Randomized, Open‐label Clinical Trial | Thrombosis, DIC, and all‐cause mortality | Therapeutic LMWH or UFH vs Prophylactic LWMH or UFH | Terminated (low recruitment) |
| NCT04344756 | Cohort Multiple Randomized Controlled Trials Open‐label of Immune Modulatory Drugs and Other Treatments in COVID‐19 Patients CORIMUNO‐COAG Trial | Survival without ventilation and ventilator‐free survival. Secondary outcomes include thrombotic complications | Therapeutic anticoagulation with tinzaparin or UFH vs prophylactic anticoagulation | Not yet recruiting |
| NCT04367831 | Intermediate or Prophylactic‐Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID‐19: A Cluster Based Randomized Selection Trial (IMPROVE‐COVID) | Clinically relevant thrombotic events | Prophylactic enoxaparin or heparin vs intermediate dose enoxaparin or heparin | Recruitment completed |
| NCT04377997 | A Randomized, Open‐Label Trial of Therapeutic Anticoagulation in COVID‐19 Patients With an Elevated D‐Dimer | Death, cardiac arrest, thrombotic event or hemodynamic shock | Therapeutic anticoagulation vs prophylactic anticoagulation | Not yet recruiting |
| NCT04512079 | FREEDOM COVID Anticoagulation Strategy Randomized Trial | All‐cause mortality, intubation, systemic VTE or ischemic stroke | Prophylactic enoxaparin vs full‐dose enoxaparin vs apixaban 5 mg every 12 h | Recruiting |
| NCT04366960 | Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID‐19 Patients (X‐Covid 19) | Incidence of VTE | Enoxaparin 40 mg twice daily vs enoxaparin 40 mg daily | Recruitment completed |
| NCT04406389 | Anticoagulation in Critically Ill Patients With COVID‐19 (The IMPACT Trial) | 30‐day mortality | Therapeutic‐dose anticoagulation vs intermediate‐dose prophylaxis | Recruiting |
| NCT04408235 | High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID‐19 Pneumonia and Coagulopathy (COVID‐19 HD) | Clinical worsening defined by death, acute MI, symptomatic arterial or venous thromboembolism, need for advanced respiratory support. | Low‐Dose LMWH group (4000 IU daily) vs. High‐Dose LMWH (70 IU/kg every 12 h) | Not yet recruiting |
| NCT04360824 | COVID‐19‐associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID‐19 | All‐cause mortality | Prophylactic‐dose enoxaparin vs intermediate‐dose enoxaparin | Recruiting |
| NCT04351724 | Austrian CoronaVirus Adaptive Clinical Trial (COVID‐19) (ACOVACT) Substudy A | Sustained improvement (>48 h) of one point on the World Health Organization Scale | Rivaroxaban 5 mg twice daily vs local standard thromboprophylaxis | Recruiting |
| NCT04829552 | Prophylactic vs Therapeutic Dose Anticoagulation in COVID‐19 Infection at the Time of Admission to Critical Care Units | All‐cause mortality | LMWH 40 mg daily or UFH 5000 IU two or three times daily vs LMWH 1 mg/kg twice or 1.5 mg/kg/d or continuous infusion of UFH | Recruitment complete |
| NCT04508439 | Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID‐19 Infection | Ventilatory support time, length of hospital stay, mortality rate | Prophylactic vs therapeutic enoxaparin | Recruiting |
| NCT04542408 | Hamburg Edoxaban for Anticoagulation in COVID‐19 Study (HERO‐19) | All‐cause mortality and/ or VTE and/or arterial thromboembolism | Prophylactic vs therapeutic enoxaparin | Recruiting |
| NCT04600141 | Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID‐19 Infection (HEPMAB) | Clinical improvement within 30 days, defined by hospital discharge or clinical status | Prophylactic vs therapeutic anticoagulation (UFH or LMWH in each group) | Recruiting |
| NCT04604327 | Comparison of Two Different Doses of Bemiparin in COVID‐19 (BEMICOP) | Death, ICU admission, mechanical ventilator support, progression to ARDS, arterial or venous thrombosis | Prophylactic bemiparin vs therapeutic bemiparin | Recruiting |
| NCT04420299 | Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID‐19 | Death, ICU admission, mechanical ventilator support, progression to ARDS, arterial or venous thrombosis | Prophylactic bemiparin vs therapeutic bemiparin | Recruiting |
| Postdischarge thromboprophylaxis | ||||
| NCT04662684 | Medically Ill Hospitalized Patients for COVID‐19 Thrombosis Extended Prophylaxis With Rivaroxaban Therapy: The MICHELLE Trial | VTE and VTE‐related death | Rivaroxaban 10 mg daily vs no intervention | Abstract available |
| NCT04650087 | COVID‐19 Post‐hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID‐19 Following Hospital Discharge | Thrombotic events and all‐cause mortality | Apixaban 2.5 mg twice daily vs placebo | Recruiting |
| NCT04508439 | Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID‐19 Infection | Thrombotic complications | Rivaroxaban 10 mg PO daily vs only clinical follow‐up | Recruiting |
| NCT04542408 | Hamburg Edoxaban for Anticoagulation in COVID‐19 Study (HERO‐19) | All‐cause mortality and/ or VTE and/or arterial thromboembolism | Edoxaban 60 mg daily vs placebo | Recruiting |
Abbreviations: ARDS, acute respiratory distress syndrome; DIC, disseminated intravascular coagulation; DVT, deep vein thrombosis; ICU, intensive care unit; LMWH, low‐molecular‐weight heparin; MI, myocardial infarction; PE, pulmonary embolism; SARS‐CoV‐2, severe acute respiratory syndrome coronavirus 2; UFH, unfractionated heparin; VTE, venous thromboembolism.