Trial IRCT20200318046812N1
Publication Solaymani-Dodaran M, Int Immunopharmacol, 2021 (published paper)
Dates: 2020-04-02 to 2020-08-03
Funding: Public/non profit (Iran University of Medical Science ; Baqiyatallah University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Iran Follow-up duration (days): 50 | |
| Inclusion criteria | Diagnosis of SARS-CoV-2 based on either a positive real-time polymerase chain reaction (RT-PCR) test or typical ground glass appearance on chest CT scan ; in need of hospital admission due to a SpO2 reduction of 93% or less ; age between 16 and 100 years ; informed and written consent. |
| Exclusion criteria | History of receiving any antiviral drug such as Ribavirin, Oseltamivir, and Lopinavir/Ritonavir for current illness ; a history of chronic renal or liver failure, or gastrointestinal bleeding; being too ill with less than 48 h life expectancy ; pregnancy and lactation; known patient of HIV infection/AIDS; QT interval above 500 ms in Electrocardiogram. |
| Interventions | |
| Treatment
Favipiravir Initial dose: 1600 mg orally - Maintenance dose: 600 mg 3 times a day for 7-10 days |
|
| Control
Lopinavir-Ritonavir ( / ) | |
| Participants | |
| Randomized 424 participants (n1=216 / n2= 208) | |
| Characteristics of participants N=424 Mean age : 57.6 205 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=373 Critical: n=0 | |
| Primary outcome | |
| In the register Admission to intensive care unit | |
| In the report Number of admissions to the intensive care unit | |
| 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 article, the trial registry was used in data extraction and the assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were no major differences between the prospective registry and the published article in population, procedures and interventions, except for change of dosage of co-intervention hydroxychloroquine based on changing guidelines. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Some outcomes in the trial registry were not reported (maximum oxygen flow, return of blood cell count and CRP values to normal, Radiological Treatment Response). The study achieved its pre-stated target sample size. 4 centers (44 patients) were excluded from the study because of unsatisfactory monitoring and their details are not reported in the paper. |