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

Sponsor
Ina-Respond (Other)
Overall Status
Recruiting
CT.gov ID
NCT04613271
Collaborator
Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia (Other)
210
Enrollment
3
Locations
2
Arms
14.5
Anticipated Duration (Months)
70
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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 Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
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 :
Oct 15, 2020
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Treatment Group

    		•
    Active Comparator: Group 2

    Administration Group 2: 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 Names:
  • Treatment Group

    • Drug: Azithromycin
    Azithromycin 500 mg once a day for 5 days.
    Other Names:
  • Group 2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative [until 3 days]

      Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3

    Secondary Outcome Measures

    1. Duration of hospitalization [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Adult patients 18 years - 59 years

    2. 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

    3. Patients with mild-moderate clinical manifestations were admitted to the hospital designated by the physician according to the operational definition of the study protocol

    4. Have not received COVID-19 antiviral therapy

    5. Consciously and voluntarily participate in research

    Exclusion Criteria:

    1. Pregnant and lactating women

    2. Allergy history to Favipiravir and standard hospital drugs

    3. Patients with uric acid examination values above normal male> 7 mg / dL; women> 5.7 mg / dL

    4. Patients with a history of prolonged ECG / Arrhythmia / QT disorders

    5. Cannot swallow drug

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RSJ Soerodjo Magelang Central Java Indonesia 56115
    2 RSUP Dr. Kariadi Semarang Central Of Java Indonesia 50244
    3 RSPI Sulianti Saroso Jakarta DKI Jakarta Indonesia 14340

    Sponsors and Collaborators

    • Ina-Respond
    • Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ina-Respond
    ClinicalTrials.gov Identifier:
    NCT04613271
    Other Study ID Numbers:
    • FVR
    • U1111-1263-1797
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ina-Respond
    Favipiravir
    Covid19
    SARS-Cov2
    Additional relevant MeSH terms:
    COVID-19
    Communicable Diseases
    Infections
    Severe Acute Respiratory Syndrome
    Azithromycin
    Favipiravir

    Study Results

    No Results Posted as of Oct 5, 2021