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

• ClinicalTrials.gov Identifier: NCT04613271
• Recruitment Status: Suspended
• First Posted: November 3, 2020
• Last Update Posted: January 27, 2021
• Sponsor: Ina-Respond
• 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

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
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

Study Design

• 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

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 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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

• 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
• Last Update Posted: January 27, 2021
• Last Verified: January 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

Keywords provided by Ina-Respond:

Favipiravir; Covid19; SARS-Cov2

Additional relevant MeSH terms:

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