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

Covid19 Clinical Trial

— FVR  

Official title:

Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613271
• Other study ID #: FVR
• Secondary ID: U1111-1263-1797
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: March 2023
• Source: Ina-Respond
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 8, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• Infectious Disease
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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.
• Azithromycin
Azithromycin 500 mg once a day for 5 days.

Locations

Country	Name	City	State
Indonesia	RSPI Sulianti Saroso	Jakarta	DKI Jakarta
Indonesia	RSJ Soerodjo	Magelang	Central Java
Indonesia	RSUP Dr. Kariadi	Semarang	Central Of Java

Sponsors (2)

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

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative	Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3	until 3 days
Secondary	Duration of hospitalization	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.	until 19 days