Trial NCT04521400
Publication Darazam IA, Int Immunopharmacol (2021) (published paper)
Dates: 2020-08-20 to 2020-09-04
Funding: Public/non profit (Shahid Beheshti University of Medical Sciences, Tehran, Iran)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Iran Follow-up duration (days): 21 | |
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Treatment
Interferon beta-1a High 1 Subcutaneous injections of I FN-beta 1a 88 mcg (24 million IU) of on days 1, 3, 6 |
|
Control
Interferon beta-1a 1 Subcutaneous injections of I FN-beta 1a 44 mcg (12 million IU) of on days 1, 3, 6 | |
Participants | |
Randomized participants : Interferon beta-1a=85 Interferon beta-1a High=83 | |
Characteristics of participants N= 168 Mean age : NR 104 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Time to clinical improvement [ Time Frame: From date of randomization until 14 days later ] Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first. | |
In the report Primary outcome measure was TTCI [Time to clinical improvement]defined as the time from enrollment to discharge or decline of two steps on the seven-step ordinal scale. | |
Documents available |
Protocol Yes. In English 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 pre-print article, study protocol, published protocol summary and prospective trial registry were used in data extraction and assessment of risk of bias. There were some differences in outcomes and endpoints between the published article, the study protocol, published protocol summary and prospective trial registry, although overall the study was reported as planned. The study achieved its pre-stated sample size. Inconsistent reporting on blinding: The trial is registered as 'open-label and the registry and protocol report the study as unblinded, however the published article reports that patients and outcome assessors are blinded to treatment arms. On the 26th of July, 2021, this study was updated based on the publication. |