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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-1797 | Other Identifier | WHO UTN Number |
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| Name | Class |
|---|---|
| National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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. |
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| Group 2 | Active Comparator | Administration Group 2: Azithromycin 500 mg once a day for 5 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir | Drug | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSJ Soerodjo | Magelang | Central Java | 56115 | Indonesia | ||
| RSUP Dr. Kariadi |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Azithromycin | Drug | Azithromycin 500 mg once a day for 5 days. |
|
|
| Semarang |
| Central of Java |
| 50244 |
| Indonesia |
| RSPI Sulianti Saroso | Jakarta | DKI Jakarta | 14340 | Indonesia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| Organic Chemicals |