Covid-19 Living Data

Trial 0112U001413 (Ukraine)
Publication Oliynyk O, Life (2021) (published paper)
Dates: 2020-07-01 to 2021-03-01
Funding: Public/non profit (Ministry of Science and Higher Education in Poland)
Conflict of interest: No

Methods
	RCT
	Location : Single center / Ukraine Follow-up duration (days): 28
Inclusion criteria	Confirmed SARS-CoV-2 infection (confirmed with a positive reverse transcription polymerase chain reaction (RT PCR) test) Presence of bilateral interstitial pneumonia on a computed tomography (CT) scan Respiratory failure with arterial partial pressure of oxygen (PaO2) < 60 mm Hg with room air D-dimer level > 3 mg/L Platelet count < 120 × 109/L Informed consent of the patient or their legal representative to participate in the study
Exclusion criteria	Respiratory failure requiring intubation prior to enrolment Hypersensitivity to enoxaparin sodium or unfractionated heparin History of heparin-induced type-II thrombocytopenia caused by the use of unfractionated heparin or low-molecular-weight heparin Clinically significant active bleeding Creatinine clearance (Cockcroft-Gault formula) < 30 mL/min Unstable arterial hypertension (systolic pressure > 180 mmHg or diastolic pressure > 110 mmHg) Pulmonary embolism (PE) confirmed by a CT pulmonary angiography Pregnancy or breastfeeding Participation in other clinical studies
Interventions
	Treatment Therap LMWH 100 IU/kg/day subcutaneously twice a day until D-dimer normalized Therap UFH Initial dose: 80 U/kg/h intravenously; Maintenance dose: 18 U/kg/h intravenously until the D-dimer values normalized
	Control Prophylactic AC 50 IU/kg/day subcutaneously once a day until D-dimer normalized
Participants
	Randomized participants : Prophylactic AC=42 Therap LMWH=42 Therap UFH=42
	Characteristics of participants N= 126 Mean age : NR 76 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=126 Number of vaccinated participants: NR
Primary outcome
	In the register NR
	In the report NR
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
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	Only the published article was used in data extraction and risk of bias assessment. The protocol, statistical analysis plan and study registry were not available. There is no information on whether the study achieved the target sample size or if the interventions, control treatments or outcomes were determined a-priori. Of note, 4 patients in the UFH (control) group were withdrawn from the study due to adverse events and provided with LMWH (treatment), but there was no information on which LMWH treatment arm they were moved to or which group they were analyzed in.