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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Infectious Disease; SARS-CoV Infection
• Intervention / Treatment: Drug: Favipiravir; Drug: Azithromycin

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dr. dr. Armedy Ronny Hasugiana, M. Biomed, MD; Phone Number: +62 21 42879189; Email: medyrh@gmail.com

Study Locations

• Indonesia
  • Central Java
    • Magelang, Central Java, Indonesia, 56115
      • Recruiting
      • RSJ Soerodjo
      • Principal Investigator: Dr Harli Amir Mahmudji, SpPD KEMD
  • Central Of Java
    • Semarang, Central Of Java, Indonesia, 50244
      • Recruiting
      • RSUP Dr. Kariadi
      • Principal Investigator: dr.Sofyan Budi Raharjo, SpP FISR
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 14340
      • Recruiting
      • RSPI Sulianti Saroso
      • Contact: dr. Adria Rusli, Sp.P
      • Principal Investigator: dr. Adria Rusli, Sp.P

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ina-Respond
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 25, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Covid19; Favipiravir; SARS-Cov2
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Infections; Communicable Diseases; Anti-Infective Agents; Antiviral Agents; Anti-Bacterial Agents; Favipiravir; Azithromycin
• Other Study ID Numbers: FVR; U1111-1263-1797 (Other Identifier: WHO UTN Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No