Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia (FVR)
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| ClinicalTrials.gov Identifier: NCT04613271 |
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Recruitment Status :
Recruiting
First Posted : November 3, 2020
Last Update Posted : October 5, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infectious Disease SARS-CoV Infection Covid19 | Drug: Favipiravir Drug: Azithromycin | Phase 3 |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 210 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: |
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| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia |
| Actual Study Start Date : | October 15, 2020 |
| Estimated Primary Completion Date : | December 30, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
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
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. Other Name: Treatment Group |
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Active Comparator: Group 2
Administration Group 2: Azithromycin 500 mg once a day for 5 days.
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Drug: Favipiravir
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. Other Name: Treatment Group Drug: Azithromycin Azithromycin 500 mg once a day for 5 days.
Other Name: Group 2 |
- Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative [ Time Frame: until 3 days ]Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3
- Duration of hospitalization [ Time Frame: until 19 days ]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.
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| Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT04613271
| Contact: Dr. dr. Armedy Ronny Hasugiana, M. Biomed, MD | +62 21 42879189 | medyrh@gmail.com |
| Indonesia | |
| RSJ Soerodjo | Recruiting |
| Magelang, Central Java, Indonesia, 56115 | |
| Principal Investigator: Dr Harli Amir Mahmudji, SpPD KEMD | |
| RSUP Dr. Kariadi | Recruiting |
| Semarang, Central Of Java, Indonesia, 50244 | |
| Principal Investigator: dr.Sofyan Budi Raharjo, SpP FISR | |
| RSPI Sulianti Saroso | Recruiting |
| Jakarta, DKI Jakarta, Indonesia, 14340 | |
| Contact: dr. Adria Rusli, Sp.P | |
| Principal Investigator: dr. Adria Rusli, Sp.P | |
| Principal Investigator: | Dr. dr. Armedy Ronny Hasugiana, M. Biomed, MD | Center for R & D of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia |
| Responsible Party: | Ina-Respond |
| ClinicalTrials.gov Identifier: | NCT04613271 |
| Other Study ID Numbers: |
FVR U1111-1263-1797 ( Other Identifier: WHO UTN Number ) |
| First Posted: | November 3, 2020 Key Record Dates |
| Last Update Posted: | October 5, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Favipiravir Covid19 SARS-Cov2 |
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COVID-19 Communicable Diseases Infections Severe Acute Respiratory Syndrome Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Disease Attributes Pathologic Processes Azithromycin Favipiravir Anti-Bacterial Agents Anti-Infective Agents Antiviral Agents |