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

University of Indonesia (UI)

Status and phase: Unknown; Phase 3

Conditions: Covid19

Treatments: Drug: Favipiravir; Drug: Oseltamivir 75mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04558463

20-04-0455

Details and patient eligibility

About

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)

Full description

This open-label trial 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 clinical improvements determined by laboratory measurements and radiology results. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Favipiravir

Experimental group

Description:

The favipiravir group received loading dose and maintenance dose of Favipiravir for 2 up to 7 days in addition to standard therapy

Treatment:

Drug: Favipiravir

Oseltamivir

Active Comparator group

Description:

The oseltamivir group was given oseltamivir for 7 days.

Treatment:

Drug: Oseltamivir 75mg