Trial NCT04521400
Publication Darazam I, 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 (Islamic Republic of) Follow-up duration (days): 21 | |
| Inclusion criteria | Age ≥ 18 years; oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24; presence of at least one of following manifestations on admission: Cough, shortness of breath,nasal congestion/ discharge, myalgia/arthralgia, radiation contactless body temperature ≥ 37.8, diarrhea/vomiting and headache or fatigue; The patients’ symptoms must be in acute phase (≤ 14 days) |
| Exclusion criteria | Refusal to participate; receiving drugs with interactions with lopinavir/ritonavir or Interferon-β 1a; a fivefold rise in serum AST/ALT relative to upper limit of normal laboratory results; pregnant or lactating women; history of alcohol or drug addiction in the past 5 years; intubated less than one hour after admission to the hospital |
| Interventions | |
| Treatment
Interferon beta 1-a High dose 1 Subcutaneous injections of I FN-beta 1a 88 mcg (24 million IU) of on days 1, 3, 6 |
|
| Control
Interferon beta 1-a Low dose ( / ) | |
| Participants | |
| Randomized 168 participants (n1=83 / n2= 85) | |
| Characteristics of participants N=168 Mean age : 59.8 104 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| 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 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 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. |