Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

Study Overview
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Brief Summary
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The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.

Detailed Description
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Pre-screening is assessing patients who meet the inclusion and exclusion criteria. Screening was carried out to assess whether the subjects met the inclusion and exclusion criteria. Randomization was performed to determine the study drug allocation. The research subjects were inpatients at selected hospitals and at the time of recruitment, the time was called D1. The next day is called D2 and so on Follow-up will be carried out from the first day of recruitment, taking medication up to a maximum of 19 days for test drugs and 11 days for SoC drugs. Recording of clinical and laboratory manifestations will be carried out from recruitment until the patient returns from the hospital. All results will be recorded in a case report form, and if a case of clinical and laboratory manifestations is found to be severe, it will be written on the adverse case report form and reported immediately according to standard GCP procedures. Subjects may also drop out of the study due to discontinuation of follow-up or a protocol violation

Official Title
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Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

Conditions
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Covid19, SARS-CoV Infection, Infectious Disease

Intervention / Treatment
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* Drug: Favipiravir
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 18 years - 59 years Confirmation of Covid-19 based on the results of the Real Time PCR (RTPCR) examination for SARS-COV-2 less than 7 days before the first day of taking the drug Patients with mild-moderate clinical manifestations were admitted to the hospital designated by the physician according to the operational definition of the study protocol Have not received COVID-19 antiviral therapy Consciously and voluntarily participate in research Exclusion Criteria: Pregnant and lactating women Allergy history to Favipiravir and standard hospital drugs Patients with uric acid examination values above normal male> 7 mg / dL; women> 5.7 mg / dL Patients with a history of prolonged ECG / Arrhythmia / QT disorders Cannot swallow drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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: Group 1: Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days. Group 2: Azithromycin 500 mg once a day for 5 days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Assignment of Administration Group 1: Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days. | Drug: Favipiravir<br>* Assignment of Administration Group 1: Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days.<br>* Other names: Treatment Group;|
| Active Comparator: Group 2<br>Administration Group 2: Azithromycin 500 mg once a day for 5 days. | Drug: Favipiravir<br>* Assignment of Administration Group 1: Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days.<br>* Other names: Treatment Group;Drug: Azithromycin<br>* Azithromycin 500 mg once a day for 5 days.<br>* Other names: Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative | Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3 | until 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization | Duration of hospitalization is defined as the number of days in the hospital until Day 19, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group. | until 19 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Favipiravir, Covid19, SARS-Cov2