Trial *
Publication Rashidi F, Thromb Res (2021) (published paper)
Dates: 2020-09-01 to 2021-04-30
Funding: Not reported/unclear
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Iran
Follow-up duration (days): 30
Inclusion criteria
  • Adult patients
  • positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) assay within 5 days of the index hospitalization
  • without known diagnosis of thrombosis
  • admitted to the ICU with PaO2/FiO2 (P/F) ratios <100 and D-dimer levels >3000 ng/mL.
Exclusion criteria
  • Hemodynamic instability
  • Estimated life expectancy < 24 hours
  • Pregnancy or breastfeeding
  • Active bleeding and any contraindications for thrombolytic therapy and anticoagulation therapy
  • Allergic reaction to study medications
Interventions
Treatment
tPA
Initial dose: 25 mg infused over 2 hr, 25 mg for the next 22 h - followed by UFH until aPTT of 50–70/sec until hospital discharge

Therap AC
5000 IU of UFH subcutaneously three times a day until hospital discharge
Control
Prophylactic AC
Initial dose: 80 IU/kg UFH - maintenance dose: 18 mg/kg by continuous infusion until aPTT of 50–70/sec until hospital discharge

Participants
Randomized
participants :
tPA=5
Therap AC=5
Prophylactic AC=5
Characteristics of participants
N= 15
Mean age : NR
11 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=5 Critical: n=10
Number of vaccinated participants: NR
Primary outcome
In the register
NR
In the report
P/F ratio improvement during the first 48-h of enrollment
Documents
available

Protocol

NR

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
Some concerns
General comment Only the published article was used in data extraction and assessment of risk of bias. No registry, protocol or statistical analysis plan was available and so it is not clear whether the primary outcome reported reflected a pre-specified outcome or whether the study achieved a target sample size.