Trial NCT04360824
Publication Perepu U, J Thromb Haemost (2021) (published paper)
Dates: 2020-04-26 to 2021-01-06
Funding: Public/non profit (National Institutes of Health Clinical and Translational Science Award)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / USA
Follow-up duration (days): 30
Inclusion criteria
  • Adults 18 years of age or older
  • SARS-CoV-2 infection confirmed by nasopharyngeal swab polymerase chain reaction
  • requiring hospitalization
  • admitted to an ICU and/or had a modified ISTH Overt DIC score ≥ 3
Exclusion criteria
  • Indication for full therapeutic dose anticoagulation or they had active major bleeding
  • severe thrombocytopenia (platelet count <25,000/uL)
  • current pregnancy
  • a history of acute venous or arterial thrombosis within the prior 3 months
  • or acute or chronic renal insufficiency with an estimated creatinine clearance less than 30 mL/min calculated by the modified Cockcroft and Gault formula
Interventions
Treatment
Intermediate dose
1 mg/kg daily if BMI < 30; 0.5 mg/kg twice daily if BMI ≥ 30; subcutaneously.

Control
Standard dose
40 mg daily if BMI <30 kg/m2; 30 mg twice daily or 40 mg twice daily according to the local institutional standard of practice if BMI ≥ 30; subcutaneously.

Participants
Randomized
participants :
Intermediate dose=88
Standard dose=88
Characteristics of participants
N= 176
Mean age : NR
97 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Mortality [ Time Frame: 30 Days post intervention ]
In the report
All-cause mortality at 30 days
Documents
available

Protocol

Yes. In English

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Low
General comment In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available at time of extraction. There were some differences between inclusion criteria in the registry and the article: the registry required a modified ISTH Overt DIC score ≥ 3 whereas in the article the criteria included admitted to an ICU and/or a modified ISTH Overt DIC score ≥ 3. Several secondary outcomes in the registry were not reported (Packed Red Blood Cell Transfusions, Platelet Transfusions, Fresh Frozen Plasma Transfusions, Cryoprecipitate Transfusions, Prothrombin Complex Concentrate Transfusions) while other reported secondary outcomes (acute kidney injury, ischemic stroke and myocardial infarction) were not in the registry. Exploratory laboratory biomarker outcomes will be reported separately. The study achieved its target sample size. On 27th of July, 2021, this study was updated based on published article, supplemental material, and protocol.