Overview

The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19

Status:
Recruiting

Trial end date:
2020-10-30

Target enrollment:
0

Participant gender:
All

Summary

This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Indonesia University

Treatments:

Favipiravir
Oseltamivir

Criteria

Inclusion Criteria:

1. adult patients aged 18-75 years old

2. Patients with COVID-19 showing symptoms and confirmed with positive RT PCR test AND OR
COVID-19 IgM/IgG rapid test

3. No history of favipiravir or oseltamivir allergy

4. Consented to participate in the trial.

Exclusion Criteria:

1. Pregnant women

2. Breastfeeding mother

3. Patients with markedly elevated liver enzyme (ALT and/or AST) of more than three times
from baseline level

4. Reduced kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min OR
serum creatinine > 2 mg/dL

5. Patients with history of heart failure

6. Tuberculosis infection that was treated with pyrazinamide

7. Asthma that was treated with theophylline

8. Type 2 diabetes that was treated with repaglinid