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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
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 500 mg once a day for 5 days.
RSJ Soerodjo
Magelang, Central Java, Indonesia
RSUP Dr. Kariadi
Semarang, Central of Java, Indonesia
RSPI Sulianti Saroso
Jakarta, DKI Jakarta, Indonesia
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
Time frame: until 3 days
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.
Time frame: until 19 days
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