Trial IRCT20100228003449N27
Publication Rahmani H, Int Immunopharmacol (2020) (published paper)
Dates: 2020-04-20 to 2020-05-20
Funding: Public/non profit (The authors did not receive any fund for this work)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 28
Inclusion criteria
  • Adult patients (≥18 years old) with positive PCR and clinical symptoms/signs of pneumonia (including dyspnea, cough and fever), peripheral oxygen saturation (SPO2) ≤ 93% in ambient air or arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) < 300 or SPO2/FiO2 < 315 and lung involvement in chest imaging were included
Exclusion criteria
  • Patients with serious allergic reactions to IFN, history of suicide thoughts and attempts, alanine amino transferase (ALT) > 5× the upper limit of the normal range, uncontrolled underlying diseases such as neuropsychiatric disorders, thyroid disorders, cardiovascular diseases and also pregnant and lactating women were not included. During the study period, patients who received less than 4 doses of IFN β-1b were excluded.
Interventions
Treatment
Interferon beta-1b
250 mcg subcutaneously every other day for 14 days
Control
Standard care

Participants
Randomized
participants :
Interferon beta-1b=40
Standard care=40
Characteristics of participants
N= 80
Mean age : NR
39 males
Severity : Mild: n=0 / Moderate: n=65 / Severe: n=1 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Response to the treatment (according the clinical, paraclinical and laboratory findings); Complications of the treatment (Interview and patient's record)
In the report
Time to clinical improvement
Documents
available

Protocol

NR

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 report, the study registry was used in data extraction. The study almost achieved the target sample size reported in the registry (30 patients in each arm). There is no change from the trial registration in the intervention and control treatments. No protocol or pre-specified statistical analysis plan were available.