Evaluation with favipiravir in patients with COVID-19.

Phase 2

• Conditions: Corona virus infection; B97.2

• Registration Number: RBR-85vh8fx
• Lead Sponsor: Fundação Oswaldo Cruz

Brief Summary

Data Analyses: Exploratory analyses that consider the impact on the primary outcome of the different scores at the inclusion, as well as other demographic characteristics should be performed. Similarly, the primary outcome (no progression to scores higher than 5 on the WHO progression scale), should be treated as binary outcomes, but analyses that consider the score at inclusion will be conducted. Secondary endpoints, time to viral clearance and time to resolution of clinical symptoms will be analysed in survival models. Cox regressions should include the evaluation of different conditions at the time of inclusion. Adverse events will be grouped according to MedDRa's SOC (System-Organ Class) (version 2020AB) and classified by intensity, severity, causality relationship with treatment and study arm. A sample size of 167 participants per arm will allow the detection of a 30% reduction on disease progression, considering the expected progression with worsening of medical conditions from mild-moderate to severe-terminal grade to be at least 50%, with 80% power and 5% alpha using two-tailed proportions tests in the comparison between study arms. Considering an interim analysis with only the upper bound comparison to stop the study for early efficacy, a small adjustment for 169 per group will be necessary. Considering losses during the participant recruitment process in the margin of 20%, 201 volunteers are expected to be included in each of the two study arms with a total sample size of 402 participants. > Interim Data Analysis: A Safety Data Monitoring Committee (SDMC) will conduct an interim analysis to detect early efficacy when 85 participants in each arm of the trial have finished follow-up. An alpha spending functions approach will be used for sequential comparison analyses. In addition, as data are collected, the WSSC will monitor disease progression in the control arm of the study and may recommend inclusion of patients with an increased likelihood of progression and/or recalculate the sample if progression proves to be significantly different from the initially projected 50% in the control group. As it does not involve comparison of groups, this procedure will not impact on the type 1 error. >> Primary outcome measure: Proportion of participants with mild to moderate disease 10 days after end of treatment and no progression to scores > 5 on the WHO Progression Scale; Secondary outcome measures: Virus clearance rate on days 5, 10, 15, 20, 30 measured by PCR; Time to viral clearance; Time to normalization of clinical symptoms (respiratory rate, fever, SpO2); Frequency of adverse events.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-29
• Study Completion: 2023-03-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Participants with a diagnosis of COVID-19 confirmed by PCR-RT or positive rapid antigen test; Participants aged 18 years or older; Participants with a score between 1 and 3 on the WHO Clinical Progression Scale; Participants with a score greater than or equal to 10 on the CALL Score; Consent from men to use barrier contraception during the study and one (1) week after the end of the use of study medication if the partner is of the opposite sex
• Informed consent form signed by the participant.
• Able to receive oral medication and attend protocol visits.

Exclusion Criteria

Non-hysterectomised women of childbearing age; Symptomatic patients for more than 72 hours;
Participants with severe liver failure equivalent to Child-Pugh grade C and advanced renal disease requiring haemodialysis or grade 3 or 4 according to the classification of the severity grade of adverse events of the Common Terminology Criteria for Adverse Events (CTCAE, version 5), or still, at the physician's discretion; Participants taking antiretroviral drugs or pyrazinamide, repaglinide, theophylline, famciclovir and sulindac; Disease progression greater than 5 (WHO Score) with need for intensive care; Participants who have received COVID-19 vaccine

Study & Design

• Study Type: Intervention
• Study Design: Not specified