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

NCT04558463 | Unknown Phase 3 DMC

• 1 other identifier: 20-04-0455
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Covid19

Keywords

COVID-19; Favipiravir; oseltamivir; adjuvant; effectivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Adverse event

  14 days

• Hospital length of stay (LOS)

  14 days

• Case Fatality Rate (CFR)

  14 days

Study Arms (2)

Favipiravir

EXPERIMENTAL

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

Drug: Favipiravir

Oseltamivir

ACTIVE COMPARATOR

The oseltamivir group was given oseltamivir for 7 days.

Drug: Oseltamivir 75mg

Interventions

Favipiravir DRUG

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

Also known as: Avigan® (favipiravir)

Favipiravir

Oseltamivir 75mg DRUG

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

Also known as: Oseltamivir

Oseltamivir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients aged 18-75 years old
• Patients with COVID-19 showing symptoms and confirmed with positive RT PCR test AND OR COVID-19 IgM/IgG rapid test
• No history of favipiravir or oseltamivir allergy
• Consented to participate in the trial.

You may not qualify if:

• Pregnant women
• Breastfeeding mother
• Patients with markedly elevated liver enzyme (ALT and/or AST) of more than three times from baseline level
• Reduced kidney function with estimated glomerular filtration rate (eGFR) \<30 mL/min OR serum creatinine \> 2 mg/dL
• Patients with history of heart failure
• Tuberculosis infection that was treated with pyrazinamide
• Asthma that was treated with theophylline
• Type 2 diabetes that was treated with repaglinid

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo National Referral Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir; Oseltamivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Dante S Harbuwono, MD, PhD

  Head of Division Endocrinology, Department of Internal Medicine, FMUI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dante S Harbuwono, MD, PhD

CONTACT

+62213907703; dante.saksono@ui.ac.id

Cleopas M Rumende, MD, PhD

CONTACT

+62 21 3149704; rumende_martin@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Endocrinology Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine Universitas Indonesia

Model Details: Subjects will be divided into two groups: favipiravir and oseltamivir as adjuvant therapy in addition to standard therapy

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 22, 2020
• Study Start: April 16, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)