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.
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
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
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
RSJ Soerodjo
Magelang, Central Java, Indonesia
RSUP Dr. Kariadi
Semarang, Central Of Java, Indonesia
RSPI Sulianti Saroso
Jakarta, DKI Jakarta, Indonesia
Dr. dr. Armedy Ronny Hasugiana, M. Biomed, MD, Principal Investigator
Center for R & D of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia