Trial IRCT20100228003449N28
Publication Davoudi-Monfared E, Antimicrob Agents Ch (2020) (published paper)
Dates: 2020-02-29 to 2020-04-03
Funding: drug donation only (No funding; CinnaGen Co. (drug donation))
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 28
Inclusion criteria
  • Patients with the severe disease according the previous definition with following criteria were included:
    (1) hypoxemia (need for non invasive or invasive respiratory support to provide capillary oxygen saturation above 90%)
    (2) Hypotension (systolic blood pressure less than 90 mmHg or vasopressor requirement)
    (3) renal failure secondary to COVID-19 (according to KDIGO definition)
    (4) neurologic disorder secondary to COVID-19 (decrease of 2 or more scores in Glasgow Coma Scale)
    (5) thrombocytopenia secondary to COVID-19 (platelet count less than 150000 /mm3)
    (6) severe gastrointestinal symptoms secondary to COVID-19 (vomiting/diarrhea that caused at least mild dehydration).
Exclusion criteria
  • Patients with each of the following characteristics were excluded: allergy to IFNs, receiving IFNs for any other reasons, previous suicide attempts, alanine amino transferase (ALT)> 5× the upper limit of the normal range and pregnant women.
Interventions
Treatment
Interferon beta-1a
44 mcg/mL subcutaneous injection, 3 times a week for 2 consecutive weeks
Control
Standard care

Participants
Randomized
participants :
Standard care=46
Interferon beta-1a=46
Characteristics of participants
N= 92
Mean age : NR
43 males
Severity : Mild: n=0 / Moderate: n=57 / Severe: n=4 Critical: n=20
Number of vaccinated participants: NR
Primary outcome
In the register
Response to the treatment and Complications of the treatment
In the report
Time to reach clinical response
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
High
General comment In addition to all available versions of the published report, the study registry and the pre-print article were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the registry. The primary outcome indicated in registry does not reflect the primary outcome reported in the paper. There is a discrepancy between the number of events in 28-day mortality reported in Table 5 and the number of deaths on day 28 reported in Table 4.
The extraction and risk of bias assessment for this study was updated with the published report on 17/07/2020.