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

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

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)

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Drug: Favipiravir; Drug: Oseltamivir 75mg

Detailed 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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dante S Harbuwono, MD, PhD; Phone Number: +62213907703; Email: dante.saksono@ui.ac.id
• Study Contact Backup: Name: Cleopas M Rumende, MD, PhD; Phone Number: +62 21 3149704; Email: rumende_martin@yahoo.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo National Referral Hospital
      • Contact: Dante S Harbuwono, MD, PhD; Phone Number: +62213907703; Email: dante.saksono@ui.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Favipiravir; The favipiravir group received loading dose and maintenance dose of Favipiravir for 2 up to 7 days in addition to standard therapy	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 Names: Avigan® (favipiravir)
Active Comparator: Oseltamivir; The oseltamivir group was given oseltamivir for 7 days.	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 Names: Oseltamivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Mild to moderate adverse event serious adverse event such as sever allergy and increased transaminase enzyme >3x normal limit	14 days
Hospital length of stay (LOS)	Days of hospitalization from the first dose of intervention	14 days
Case Fatality Rate (CFR)	CFR is calculated from mortality rate during hospital admission	14 days

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Dante S Harbuwono, MD, PhD, Head of Division Endocrinology, Department of Internal Medicine, FMUI

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; adjuvant; Favipiravir; oseltamivir; effectivity
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Favipiravir; Oseltamivir
• Other Study ID Numbers: 20-04-0455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No