Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ina-Respond
• Collaborator: Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia
• Treatments: Azithromycin; Favipiravir

Criteria

Inclusion Criteria:

1. Adult patients 18 years - 59 years

2. Confirmation of Covid-19 based on the results of the Real Time PCR (RTPCR) examination for SARS-COV-2 less than 7 days before the first day of taking the drug

3. Patients with mild-moderate clinical manifestations were admitted to the hospital designated by the physician according to the operational definition of the study protocol

4. Have not received COVID-19 antiviral therapy

5. Consciously and voluntarily participate in research

Exclusion Criteria:

1. Pregnant and lactating women

2. Allergy history to Favipiravir and standard hospital drugs

3. Patients with uric acid examination values above normal male> 7 mg / dL; women> 5.7 mg / dL

4. Patients with a history of prolonged ECG / Arrhythmia / QT disorders

5. Cannot swallow drug