Trial IRCT20100228003449N28
Publication Davoudi-Monfared E, Antimicrob Agents Ch, 2020 (published paper)
Dates: 2020-02-29 to 2020-04-03
Funding: Private (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 Definition of Standard care: The standard of care (the hospital protocol) consisted of hydroxychloroquine (400 mg BD in first day and then 200 mg BD) plus lopinavir/ritonavir (400/100 mg BD) or atazanavir/ritonavir (300/100 mg daily) for 7-10 days. Also primary care, respiratory support, fluid, electrolytes, analgesic, antipyretic, corticosteroid and antibiotic were recommended in the hospital protocol if indicated. Duration : 7-10 days | |
| Participants | |
| Randomized 92 participants (n1=46 / n2= 46) | |
| Characteristics of participants N=92 Mean age : 58.8 43 males Severity : Mild: n=0 / Moderate: n=57/ Severe: n=4 Critical: n=20 | |
| 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 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 |
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. |