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

Study Overview
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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)

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)

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

Conditions
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Covid19

Intervention / Treatment
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* Drug: Favipiravir
* Drug: Oseltamivir 75mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be divided into two groups: favipiravir and oseltamivir as adjuvant therapy in addition to standard therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Favipiravir<br>The favipiravir group received loading dose and maintenance dose of Favipiravir for 2 up to 7 days in addition to standard therapy | Drug: Favipiravir<br>* 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<br>* Other names: Avigan® (favipiravir);|
| Active Comparator: Oseltamivir<br>The oseltamivir group was given oseltamivir for 7 days. | Drug: Oseltamivir 75mg<br>* 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<br>* Other names: Oseltamivir;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Favipiravir, oseltamivir, adjuvant, effectivity