NCT04613271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2021

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

October 25, 2020

Last Update Submit

March 7, 2023

Conditions

Infectious DiseaseSARS-CoV InfectionCovid19

Keywords

FavipiravirCovid19SARS-Cov2

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Duration of hospitalization

    until 19 days

Study Arms (2)

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.

Drug: Favipiravir

Group 2

ACTIVE COMPARATOR

Administration Group 2: Azithromycin 500 mg once a day for 5 days.

Drug: FavipiravirDrug: Azithromycin

Interventions

FavipiravirDRUG

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.

Also known as: Treatment Group
Group 1Group 2
AzithromycinDRUG

Azithromycin 500 mg once a day for 5 days.

Also known as: Group 2
Group 2

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients 18 years - 59 years
  • 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
  • Patients with mild-moderate clinical manifestations were admitted to the hospital designated by the physician according to the operational definition of the study protocol
  • Have not received COVID-19 antiviral therapy
  • Consciously and voluntarily participate in research

You may not qualify if:

  • Pregnant and lactating women
  • Allergy history to Favipiravir and standard hospital drugs
  • Patients with uric acid examination values above normal male\> 7 mg / dL; women\> 5.7 mg / dL
  • Patients with a history of prolonged ECG / Arrhythmia / QT disorders
  • Cannot swallow drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

RSJ Soerodjo

Magelang, Central Java, 56115, Indonesia

Location

RSUP Dr. Kariadi

Semarang, Central of Java, 50244, Indonesia

Location

RSPI Sulianti Saroso

Jakarta, DKI Jakarta, 14340, Indonesia

Location

MeSH Terms

Conditions

Communicable DiseasesSevere Acute Respiratory SyndromeCOVID-19

Interventions

favipiravirAzithromycin

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

November 3, 2020

Study Start

October 15, 2020

Primary Completion

October 25, 2021

Study Completion

November 8, 2021

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

ID(3)