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

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ClinicalTrials.gov Identifier: NCT04558463
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Dante Saksono Harbuwono, Sp.PD, PhD, Indonesia University

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)

Condition or disease Intervention/treatment Phase
Covid19 Drug: Favipiravir Drug: Oseltamivir 75mg Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be divided into two groups: favipiravir and oseltamivir as adjuvant therapy in addition to standard therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19: An Open Label Trial
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oseltamivir

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 Name: 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 Name: Oseltamivir




Primary Outcome Measures :
  1. Clinical radiologic changes [ Time Frame: 14 days ]
    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

  2. Percentage of RT-PCR test convertion [ Time Frame: 14 days ]
    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


Secondary Outcome Measures :
  1. Adverse event [ Time Frame: 14 days ]
    Mild to moderate adverse event serious adverse event such as sever allergy and increased transaminase enzyme >3x normal limit

  2. Hospital length of stay (LOS) [ Time Frame: 14 days ]
    Days of hospitalization from the first dose of intervention

  3. Case Fatality Rate (CFR) [ Time Frame: 14 days ]
    CFR is calculated from mortality rate during hospital admission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558463


Contacts
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Contact: Dante S Harbuwono, MD, PhD +62213907703 dante.saksono@ui.ac.id
Contact: Cleopas M Rumende, MD, PhD +62 21 3149704 rumende_martin@yahoo.com

Locations
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Indonesia
Cipto Mangunkusumo National Referral Hospital Recruiting
Jakarta, DKI Jakarta, Indonesia, 10430
Contact: Dante S Harbuwono, MD, PhD    +62213907703    dante.saksono@ui.ac.id   
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Dante S Harbuwono, MD, PhD Head of Division Endocrinology, Department of Internal Medicine, FMUI
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Responsible Party: dr. Dante Saksono Harbuwono, Sp.PD, PhD, Principal Investigator, Head of Endocrinology Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine Universitas Indonesia, Indonesia University
ClinicalTrials.gov Identifier: NCT04558463    
Other Study ID Numbers: 20-04-0455
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr. Dante Saksono Harbuwono, Sp.PD, PhD, Indonesia University:
COVID-19
Favipiravir
oseltamivir
adjuvant
effectivity
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Oseltamivir
Favipiravir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action