Trial IRCT20151227025726N17
Publication Jamaati H, Eur J Pharmacol (2021) (published paper)

Funding: Public/non profit (Shahid Beheshti University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 28
Inclusion criteria
  • (1) Age > 18 years

  • (2) SARS-CoV-2 infection confirmed by a reverse transcription-polymerase chain reaction test

  • (3) Ratio of partial pressure of oxygen in arterial blood to fraction of inspired oxygen (PaO2/FiO2) between 100-300 mmHg
  • bilateral lung infiltration

  • (4) Provision of written informed consent by the patient
Exclusion criteria
  • (1) Chronic kidney diseases

  • (2) Chronic liver diseases

  • (3) Hyperglycemia

  • (4) Women pregnant or breastfeeding
Interventions
Treatment
Dexamethasone
20 mg/day IV infusion on days 1-5, 10 mg/day from days 6-10
Control
Standard care

Participants
Randomized
participants :
Dexamethasone=25
Standard care=25
Characteristics of participants
N= 50
Mean age : NR
36 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=50 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Need for invasive mechanical ventilation;
Death
In the report
Need for invasive mechanical ventilation and death rate
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 In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. There were no differences between the article and the registry in terms of population, procedures, interventions or outcomes, but the trial was retrospectively registered. Preliminary report of a small trial.