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

NCT ID: NCT04613271

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-11-08

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.

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

Conditions

Infectious Disease; SARS-CoV Infection; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

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.

Group 2

Administration Group 2: Azithromycin 500 mg once a day for 5 days.

Group Type: ACTIVE_COMPARATOR

Favipiravir

Intervention Type: DRUG

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.

Azithromycin

Intervention Type: DRUG

Azithromycin 500 mg once a day for 5 days.

Interventions

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.

Intervention Type: DRUG

Azithromycin

Azithromycin 500 mg once a day for 5 days.

Intervention Type: DRUG

Other Intervention Names

Treatment Group; Group 2

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Ina-Respond

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. dr. Armedy Ronny Hasugiana, M. Biomed, MD

Role: PRINCIPAL_INVESTIGATOR

Center for R & D of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia

Locations

RSJ Soerodjo

Magelang, Central Java, Indonesia

RSUP Dr. Kariadi

Semarang, Central of Java, Indonesia

RSPI Sulianti Saroso

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

U1111-1263-1797

Identifier Type: OTHER

Identifier Source: secondary_id

FVR

Identifier Type: -

Identifier Source: org_study_id