Trial IRCT20100228003449N27
Publication Rahmani H, Int Immunopharmacol, 2020 (published paper)
Dates: 2020-04-20 to 2020-05-20
Funding: No specific funding (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 Definition of Standard care: The national protocol consisted lopinavir/ritonavir (400/100 mg BD) or atazanavir/ritonavir (300/100 mg daily) plus hydroxychloroquine (400 mg BD in first day and then 200 mg BD) for 7–10 days Other supportive cares such as fluid therapy, stress ulcer prophylaxis, deep vein thrombosis, treatment of electrolyte disorders and antibiotic therapy were considered according to the hospital protocols Duration : 7-10 days | |
| Participants | |
| Randomized 80 participants (n1=40 / n2= 40) | |
| Characteristics of participants N=80 Mean age : NR 39 males Severity : Mild: n=0 / Moderate: n=65/ Severe: n=1 Critical: n=0 | |
| 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 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 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. |