Trial NCT04501783
Publication Ruzhentsova TA, Am J Transl Res, 2021 (published paper)
Dates: 2020-05-23 to 2020-06-30
Funding: Private (R-Pharm Group of Companies)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Russia Follow-up duration (days): 28 | |
| Inclusion criteria | Patients 18-60 years of age; Diagnosis of mild to moderate COVID-19 without respiratory failure; Symptom manifestation no more than 6 days before the randomization; SARS-CoV-2 confirmed by PCR of oro- or nasopharyngeal swabs; Received no previous antiviral therapy for COVID-19 |
| Exclusion criteria | Respiratory failure (SpO2≤93%); Need for mechanical ventilation at screening; Severe or extremely severe COVID-19; Severe lung damage on computed tomography (CT) scans (subtotal diffuse ground-glass induration of pulmonary tissue, the involvement of ≥75% of the lung parenchyma, hydrothorax); Unstable hemodynamics; Any of the following laboratory abnormalities at screening: AST or ALT level >2.5 × upper limit of normal (ULN), platelet count <50 × 109/L |
| Interventions | |
| Treatment
Favipiravir Initial dose: 1800 mg orally twice on day 1. Maintenance dose: 800 mg orally twice a day on days 2-10 |
|
| Control
Standard care Definition of Standard care: All patients received supportive care, including antipyretics, antibiotics, anticoagulants, and vasoconstrictor drugs. | |
| Participants | |
| Randomized 168 participants (n1=112 / n2= 56) | |
| Characteristics of participants N=168 Mean age : 41.8 79 males Severity : Mild: n=38 / Moderate: n=3/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Time to clinical improvement [Time Frame: through Day 28]; Time to viral clearance [Time Frame: through Day 28] | |
| In the report 1. Time to clinical improvement (a reduction of patient clinical status on at least 1 score according to WHO 8-Category Ordinal Scale compared to screening) and 2. Time to viral clearance (the absence of SARS-CoV-2 virus according to PCR in two consecutive swabs with an interval of at least 24 hours). | |
| Documents available |
Protocol Yes. In English Statistical plan Yes 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 published article, the pre-print article, the trial registry and the protocol were used in data extraction and assessment of risk of bias. There were no differences between the published/pre-print article, trial registry and protocol in terms of population, procedures, treatments or outcomes. The standard of care arm has been extracted as an active treatment comparison arm, since in this arm patients received either umifenovir and intranasal interferon alpha-2b or hydroxychloroquine, depending on the severity of the patient's condition. It is not reported how many patients in this arm received each of these treatments.
This study was updated on January 20th, 2022 with data from the newly published report. |