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

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Favipiravir

Oseltamivir 75mg

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Favipiravir, oseltamivir, adjuvant, effectivity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Cipto Mangunkusumo National Referral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Favipiravir

Oseltamivir

Arm Description

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

The oseltamivir group was given oseltamivir for 7 days.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Adverse event

Mild to moderate adverse event serious adverse event such as sever allergy and increased transaminase enzyme >3x normal limit

Hospital length of stay (LOS)

Days of hospitalization from the first dose of intervention

Case Fatality Rate (CFR)

CFR is calculated from mortality rate during hospital admission

Full Information

NCT ID

NCT04558463

First Posted

September 3, 2020

Last Updated

September 21, 2020

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT04558463

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 16, 2020 (Actual)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

COVID-19, Favipiravir, oseltamivir, adjuvant, effectivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Favipiravir

Arm Type

Experimental

Arm Description

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

Arm Title

Oseltamivir

Arm Type

Active Comparator

Arm Description

The oseltamivir group was given oseltamivir for 7 days.

Intervention Type

Drug

Intervention Name(s)

Favipiravir

Other Intervention Name(s)

Avigan® (favipiravir)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oseltamivir 75mg

Other Intervention Name(s)

Oseltamivir

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical radiologic changes

Description

Time Frame

14 days

Title

Percentage of RT-PCR test convertion

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Adverse event

Description

Mild to moderate adverse event serious adverse event such as sever allergy and increased transaminase enzyme >3x normal limit

Time Frame

14 days

Title

Hospital length of stay (LOS)

Description

Days of hospitalization from the first dose of intervention

Time Frame

14 days

Title

Case Fatality Rate (CFR)

Description

CFR is calculated from mortality rate during hospital admission

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dante S Harbuwono, MD, PhD

Phone

+62213907703

dante.saksono@ui.ac.id

First Name & Middle Initial & Last Name or Official Title & Degree

Cleopas M Rumende, MD, PhD

Phone

+62 21 3149704

rumende_martin@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dante S Harbuwono, MD, PhD

Organizational Affiliation

Head of Division Endocrinology, Department of Internal Medicine, FMUI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cipto Mangunkusumo National Referral Hospital

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dante S Harbuwono, MD, PhD

Phone

+62213907703

dante.saksono@ui.ac.id

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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