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

Covid19 Clinical Trial

Official title:

The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19: An Open Label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558463
• Other study ID #: 20-04-0455
• Status: Recruiting
• Phase: Phase 3
• Start date: April 16, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: September 2020
• Source: Indonesia University
• Contact: Dante S Harbuwono, MD, PhD
• Phone: +62213907703
• Email: dante.saksono[@]ui.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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
• 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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Referral Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical radiologic changes	Changes of lung infiltrate in chest xray AND/OR GGO in chest CT scan after 14 days of follow up period This outcome measured will displayed as improvement/no changes/deterioration of radiologic examination results	14 days
Primary	Percentage of RT-PCR test convertion	Convertion of RT-PCR swab result from positive to negative at the end of 14 days study follow up This outcome measured will displayed as convertion OR no conversion	14 days
Secondary	Adverse event	Mild to moderate adverse event serious adverse event such as sever allergy and increased transaminase enzyme >3x normal limit	14 days
Secondary	Hospital length of stay (LOS)	Days of hospitalization from the first dose of intervention	14 days
Secondary	Case Fatality Rate (CFR)	CFR is calculated from mortality rate during hospital admission	14 days