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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2020-10-30

Brief Summary

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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)

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Detailed Description

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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)

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Favipiravir

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

Group Type EXPERIMENTAL

Favipiravir

Intervention Type 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

Oseltamivir

The oseltamivir group was given oseltamivir for 7 days.

Group Type ACTIVE_COMPARATOR

Oseltamivir 75mg

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Avigan® (favipiravir) Oseltamivir

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR