Trial NCT04349241
Publication - Dabbous HM, Scientific Reports, 2021 (published paper)
Dates: 2020-04-18 to 2020-05-18
Funding: Private (Rameda Pharmaceutical Company)
Conflict of interest: No
| Methods | |
| *RCT Blinding: Unblinded | |
| Location :
Multicenter / Egypt Follow-up duration (days): 40 | |
| Inclusion criteria | Adults between 18 and 80 years with confirmed COVID-19 documented by a diagnostic laboratory test (e.g., nasopharyngeal swab) at the time of illness and having mild to moderate symptoms according to the national protocol classification of patients. |
| Exclusion criteria | Patients who had severe disease defined as
presence of dyspnea, respiratory rate ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of
arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48
hours or life-threatening disease defined as respiratory failure, septic shock, and/or multiple organ
dysfunction or failure;
Pregnant or lactating females or those participating in any investigational clinical study, other than observational, within the previous 30 days. |
| Interventions | |
| Treatment
Favipiravir 600mg PO twice daily for 9 days |
|
| Control
Standard care Definition of Standard care: Oseltamivir 75 mg 12 hourly for 10 days and hydroxychloroquine 400 mg 12 hourly on day-one followedby 200 mg 12 hourly daily on day-2 to 10 days conforming to the national standard of care therapy. | |
| Participants | |
| Randomized 100 participants (n1=50 / n2= 50) | |
| Characteristics of participants N=100 Mean age : 36.4 50 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register 1) Viral clearance [ Time Frame: 14 days ]; 2) Clinical improvement [ Time Frame: 14 days ] | |
| In the report Achievement of two successive negative SARS-CoV-2 PCR analysis tests 48 hours apart by nasopharyngeal swab, normalization of body temperature for 48 hours, improvement of radiological abnormalities at day 14 and discharge rate out of the hospital | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 pre-print article, the study registry was used in data extraction and assessment of risk of bias. National standard of care therapy consisted of oseltamivir 75 mg 12 hourly for 10 days and hydroxychloroquine 400 mg 12 hourly on day-one followedby 200 mg 12 hourly daily on day-2 to 10 days. The study achieved the proposed sample size. There were no differences between the trial registration and the study report in treatments. One primary outcome stated in the report (discharge out of hospital) was not specified in the trial registration. Also, 'Improvement of radiological abnormalities' was specified as a secondary outcome in the registry but a primary outcome in the report, while the secondary outcomes, 'normalization of C-reactive protein (CRP) and serum ferritin levels', were not specified in the registry. On 12th of April, 2021, this study was updated based on the published report. |