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letter
. 2020 Jul 6;4(5):731–736. doi: 10.1002/rth2.12372

TABLE 1.

Antithrombotic trials in COVID‐19 listed in ClinicalTrials.gov (https://clinicaltrials.gov/)

Trial Design Primary end point
Stage 1/2

COVID‐19–Associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID‐19

ClinicalTrials.gov Identifier: NCT04360824

Country: United States

Prospective, randomized, open‐label, single‐center interventional study comparing the safety and efficacy of 2 LMWH dosing protocols in patients meeting the modified ISTH Overt DIC criteria score ≥ 3. Patients will be randomized to standard prophylactic dose LMWH (standard‐of‐care arm) or intermediate‐dose LMWH (intervention arm). Mortality at 30 d after intervention and risk of all‐cause mortality

Randomized Trial of Anticoagulation Strategies in COVID‐19

ClinicalTrials.gov Identifier: NCT04359277

Country: United States

Open‐label randomized trial of higher‐dose anticoagulation with enoxaparin or unfractionated intravenous heparin compared with lower‐dose prophylactic anticoagulation All‐cause mortality at 1 y and incidence of cardiac arrest, symptomatic deep vein thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, or hemodynamic shock in 21 d

Intermediate or Prophylactic‐Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID‐19 (IMPROVE)

ClinicalTrials.gov Identifier: NCT04367831

Country: United States

Intermediate‐dose anticoagulation with enoxaparin or UFH versus prophylactic dose anticoagulation

Composite of being alive and without clinically relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 d (if ICU duration lasted 30 d or longer).

Preventing COVID‐19 Complications With Low‐ and High‐Dose Anticoagulation (COVID‐HEP)

ClinicalTrials.gov Identifier: NCT04345848

Country: Switzerland

Therapeutic anticoagulation with enoxaparin or intravenous UFH compared with prophylactic enoxaparin or UFH, from admission until the end of hospital stay or clinical recovery. If hospitalized in theICU, an augmented thromboprophylaxis regimen as standard of care.

Composite outcome of arterial or venous thrombosis, DIC, and all‐cause mortality

Coagulopathy of COVID‐19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care (RAPID COVID COAG)

ClinicalTrials.gov Identifier: NCT04362085

Country: United States

2‐arm, parallel, multicenter, open‐label randomized controlled trial in hospitalized patients with COVID‐19 and an elevated D‐dimer (≥2 times the upper limit of normal).

Therapeutic anticoagulation with LMWH or UFH until discharged from hospital, 28 d, or death versus standard care (LMWH, UFH, or fondaparinux at thromboprophylactic doses)

Composite outcome of ICU admission, noninvasive positive pressure ventilation, invasive mechanical ventilation, or death at 28 d

Trial Evaluating Efficacy and Safety of Anticoagulation in Patients With COVID‐19 Infection, Nested in the Corimmuno‐19 Cohort (CORIMMUNO‐COAG)

ClinicalTrials.gov Identifier: NCT04344756

Country: France

Phase 2 randomized open‐label multicenter clinical trial, where patients will be randomly allocated to anticoagulation versus standard of care

Survival without ventilation and ventilator‐free survival

Efficacy of Nafamostat in Covid‐19 Patients (RACONA Study)

ClinicalTrials.gov Identifier: NCT04352400

Country: Italy

Adult hospitalized patients with COVID‐19 in randomized, prospective, double‐blind trial to test the clinical efficacy of nafamostat mesylate in addition to best standard of care. Time to clinical improvement on a 7‐category ordinal scale or live discharge from the hospital, whichever came first.
STAGE 3

STARS ("STudy of Alteplase for Respiratory Failure in SARS‐Cov2 (COVID‐19)": A Phase IIa Clinical Trial

ClinicalTrials.gov Identifier: NCT04357730

Country: United States

Phase IIa, open‐label, modified stepped‐wedge design, testing systemic administration of fibrinolytic therapy with alteplase (t‐PA) versus standard of care for patients with COVID‐19 resulting in severe respiratory failure.

PaO2/FiO2 improvement from pre‐ to post‐intervention at 48 h after randomization

Nebulised rt‐PA for ARDS Due to COVID‐19 (PACA)

ClinicalTrials.gov Identifier: NCT04356833

Country: United Kingdom

Recombinant tissue‐plasminogen Activator (rt‐PA) given every 6 h for 66 h, in addition to standard of care for COVID‐19 acute respiratory distress syndrome versus standard of care

Treatment efficacy measured as percentage change in PaO2/FiO2 ratio from baseline and to day 5 and day 7.

Safety measured by bleeds and other (non–bleed‐related) adverse events and fibrinogen levels.

CORIMUNO19‐ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID‐19 Infection, Nested in the CORIMUNO‐19 Cohort

ClinicalTrials.gov Identifier: NCT04346797

Country: France

Cohort, randomized controlled trial design

Randomization between eculizumab plus standard of care versus standard of care

.

Outcomes compared with outcomes of standard‐of‐care–treated patients as well as with outcomes of patients treated with other immune modulators.

Enhanced Platelet Inhibition in Critically Ill Patients With COVID‐19 (PIC‐19)

ClinicalTrials.gov Identifier: NCT04368377

Country: Italy

Compassionate‐use, proof‐of‐concept, phase IIb, prospective, interventional, pilot study of intravenous tirofiban with intravenous acetylsalicylic acid, oral clopidogrel, and subcutaneous fondaparinux 2.5 mg, in patients affected by severe respiratory failure in COVID‐19–associated pneumonia who underwent treatment with continuous positive airway pressure.

Change in ratio between partial pressure of oxygen in arterial blood and inspired oxygen fraction and change in alveolar‐arterial gradient of oxygen at baseline and after study treatment.