Clinical trial NCT04613271: Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
Official title: Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infectious Disease
SARS-CoV Infection
Covid19
Keywords: Favipiravir
Covid19
SARS-Cov2
Lead sponsor: Ina-Respond
Sponsor class: OTHER
Collaborators: name: Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia
First posted: 2020-11-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative
timeFrame: until 3 days
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: until 19 days
Other outcomes:
Locations:
city: Magelang
country: Indonesia
facility: RSJ Soerodjo
state: Central Java
city: Semarang
country: Indonesia
facility: RSUP Dr. Kariadi
state: Central Of Java
city: Jakarta
country: Indonesia
facility: RSPI Sulianti Saroso
state: DKI Jakarta
Study officials:
affiliation: Center for R & D of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia
name: Dr. dr. Armedy Ronny Hasugiana, M. Biomed, MD
role: PRINCIPAL_INVESTIGATOR
References: