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 ( / ) Definition of Standard care: Patients in both groups received oxygen support (CPAP with pressure of 5-10 cmH2O and FIO2 equal to 60 to achieve SPO2≥90% and the duration was different according to the monitoring of patients’ clinical status), fluid support, and lopinavir/ritonavir (200/50 mg, two tablets twice a day) according to the National Iranian Guidelines | |
Participants | |
Randomized 50 participants (n1=25 / n2= 25) | |
Characteristics of participants N=50 Mean age : NR 36 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=50 Critical: n=0 | |
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 stated 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 | 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. |