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)
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)
Drug: Favipiravir
The favipiravir group received loading dose of 1600 mg twice a day (3200 mg/day) on the first day and continued with 600 mg twice a day (1200 mg/day) for the next 2nd - 7th day in addition to the standard therapy.
Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug
Other Name: Avigan® (favipiravir)
Drug: Oseltamivir 75mg
The oseltamivir group was given twice a day of 75 mg of oseltamivir (150 mg/day) for 7 days in addition to standard therapy
Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug
Other Name: Oseltamivir
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
Cipto Mangunkusumo National Referral Hospital
Jakarta, DKI Jakarta, Indonesia
Investigator: Dante S Harbuwono, MD, PhD
Contact: +62213907703
dante.saksono@ui.ac.id
Dante S Harbuwono, MD, PhD
+62213907703
dante.saksono@ui.ac.id
Cleopas M Rumende, MD, PhD
+62 21 3149704
rumende_martin@yahoo.com
Dante S Harbuwono, MD, PhD, Principal Investigator
Head of Division Endocrinology, Department of Internal Medicine, FMUI