Covid-19 Living Data

Trial RBR-949z6v
Publication Lemos ACB, Thromb Res (2020) (published paper)
Dates: 2020-04-01 to 2020-07-30
Funding: No specific funding (None)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Brazil Follow-up duration (days): 28
Inclusion criteria	Age over 18 years-old SARS-CoV-2 infection confirmed by RT-PCR presence of acute respiratory distress syndrome according to the Berlin definition severe clinical presentation with respiratory failure requiring mechanical ventilation D-dimer levels greater than 1000 μg/L prothrombin time/international normalized ratio (INR) < 1.5 activated partial thromboplastin time (aPTT)/ratio < 1.5 platelet count greater than 100,000/mm3.
Exclusion criteria	Age greater than 85 years creatinine clearance < 10 mL/min severe circulatory shock with a dose of norepinephrine higher than 1.0 μg/kg/min chronic renal failure in renal replacement therapy Child B and C chronic liver disease advanced diseases, such as active cancer, heart failure chronic obstructive pulmonary disease using home oxygen advanced dementia significant disability from stroke or severe head injury cardiorespiratory arrest pregnant women major surgery or severe trauma in the last 3 weeks stroke in the last 3 months active bleeding blood dyscrasia such as hemophilia Von Willebrand factor deficiency participation in another clinical investigation indication for therapeutic anticoagulation due to pulmonary embolism acute coronary syndrome.
Interventions
	Treatment Therap EX 1 mg/kg subcutaneously twice a day (maximum 140 mg twice a day) for 4-14 days
	Control Prophylactic AC heparin: 5000 IU subcutaneously 3 times a day (if weight < 120 kg) and 7500 IU 3 times a day (if weight > 120 kg) OR enoxaparin: 40 mg once daily (if weight < 120 kg) and 40 mg twice daily (if weight > 120 Kg) according to the doctor's judgment.
Participants
	Randomized participants : Therap EX=10 Prophylactic AC=10
	Characteristics of participants N= 20 Mean age : NR 16 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=20 Number of vaccinated participants: NR
Primary outcome
	In the register Evaluation of gas exchange between D0 / D4 /D7 /D14 evaluated through the PO2 / FIO2 ratio; days without mechanical ventilation (within 28 days of follow-up, how many days were out of mechanical ventilation, if the patient dies before 28 days of foll
	In the report Variation in gas exchange over time evaluated through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization
Documents available	Protocol Yes. In language other than English Statistical plan NR Data-sharing willing stated in the publication:
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	Some concerns
General comment	In addition to the published study report, the protocol (available in Portuguese) and trial registry were used in data extraction and assessment of risk of bias. The study differed from its original protocol in that there are only two arms in the reported trial whereas three were intended, but the authors are transparent about this, stating the reason for the abandonment of the third arm. The reported study achieved the sample size proposed in the protocol. Whereas the protocol stated that Enoxaparin may be extended up to 7-10 days at the discretion of the medical team, the published article reports maintaining treatment for up to 14 days. There were no substantive differences in outcomes between the registry or protocol and the published study report.