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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613271
Recruitment Status : Suspended (Study halted prematurely but potentially will resume, the protocol will be amended)
First Posted : November 3, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia
Information provided by (Responsible Party):
Ina-Respond

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
Infectious Disease SARS-CoV Infection Covid19 Drug: Favipiravir Drug: Azithromycin 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : June 30, 2021
Estimated Study Completion Date : June 30, 2021


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 Name: 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 Name: Treatment Group

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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Indonesia
RSJ Soerodjo
Magelang, Central Java, Indonesia, 56115
RSUP Dr. Kariadi
Semarang, Central Of Java, Indonesia, 50244
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
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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
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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: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Communicable Diseases
Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents