Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

FVR

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.

2020-10-15

2021-10-25

2021-11-08

Completed

Early phase I

130

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Group 1: Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days.\n* Group 2: Azithromycin 500 mg once a day for 5 days.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 130, 'type': 'ACTUAL'}}

2023-03-08