Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04613271
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2020-10-25
Brief Title:
Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
Sponsor:
Ina-Respond
Organization:
Ina-Respond
Study Overview
Official Title:
Phase III Random-Open Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FVR
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1263-1797 | OTHER | WHO UTN Number | None |