Trial IRCT20200404046947N1
Publication Edalatifard M, Eur Respir J (2020) (published paper)
Dates: 2020-04-20 to 2020-06-20
Funding: Public/non profit (Deputy of Research, Tehran University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Multicenter / Iran
Follow-up duration (days): 60
Inclusion criteria
  • Aged 18 years or older
  • Confirmed COVID-19 (RT-PCR)
  • Abnormal computed tomography (CT) scan with blood oxygen saturation <90%, elevated C-reactive protein (CRP >10), and interleukin (IL)-6 (>6) at the early pulmonary phase of disease before connecting to the ventilator and intubation,agreed to give informed consent.
Exclusion criteria
  • Patients intolerant or allergic to any therapeutic agents used in this research
  • Pregnant or lactating women
  • blood oxygen saturation <75%, positive pro-calcitonin (PCT) and troponin test, Acute Respiratory Distress Syndrome (ARDS), uncontrolled hypertension (HTN), uncontrolled diabetes mellitus (DM), gastrointestinal problems or gastrointestinal bleeding (GIB) history, heart failure (HF), active malignancies and received any immune-suppressor agents.
Interventions
Treatment
IVMP Pulse
250 mg IV injection once a day for 3 days
Control
Standard care

Participants
Randomized
participants :
IVMP Pulse=34
Standard care=34
Characteristics of participants
N= 68
Mean age : NR
39 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=68 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Radiographic features Findings
In the report
time of clinical improvement and discharge from the hospital or death whichever came first
Documents
available

Protocol

NR

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 article, the study registry was used in data extraction and risk of bias assessment. The trial registration was updated between completion and submission of report manuscript for publication to change from double-blinded to single-blinded, increase the sample size from 40 to 68, and alter the timing of outcome measurement. The primary outcome and some other outcomes in the published report differ from those in the registration. There is no change from the trial registration in the intervention and control treatments. The primary outcome and some other outcomes in the published report differ from those in the registration.