Infectious DiseasePhase 3FVRNCT04613271
Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
A Phase 3 study testing Favipiravir and Azithromycin in people with Infectious Disease and SARS-CoV Infection, run by Ina-Respond at 3 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Infectious Disease, SARS-CoV Infection, Covid19
- What is being tested?
- Favipiravir and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesIndonesia
- Study dates
- 15 Oct 2020to 8 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
RSPI Sulianti Saroso
Jakarta, DKI Jakarta, 14340
RSJ Soerodjo
Magelang, Central Java, 56115
RSUP Dr. Kariadi
Semarang, Central of Java, 50244
About this study
Official title: Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
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.
Read the 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
- Conditions
- Infectious Disease, SARS-CoV Infection, Covid19
- Being tested
- Favipiravir, Azithromycin
- Keywords
- Favipiravir, Covid19, SARS-Cov2
- Medical subject headings
- Communicable Diseases, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Also called Treatment Group
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.
AzithromycinDrug
Also called Group 2
Azithromycin 500 mg once a day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Favipiravir |
| Group 2 | Active comparator | Administration Group 2: Azithromycin 500 mg once a day for 5 days. Receives: Drug: Favipiravir; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: until 3 days
Secondary outcomes (1)
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.
Measured: until 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start15 Oct 2020
- Primary completion25 Oct 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ina-Respond
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613271
- Sponsor's protocol ID
- FVR
- Other IDs
- U1111-1263-1797
- Acronym
- FVR
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
- ClinicalTrials.gov ID
- NCT04613271
- Acronym / sponsor ID
- FVR / FVR
- Conditions
- Infectious Disease, SARS-CoV Infection, Covid19
- Keywords
- Favipiravir, Covid19, SARS-Cov2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ina-RespondUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: FavipiravirAssignment 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. |
| Group 2 | Active comparator | Drug: Favipiravir, Drug: AzithromycinAdministration Group 2: Azithromycin 500 mg once a day for 5 days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FavipiravirAlso: Treatment GroupAssignment 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 | Group 1, Group 2 |
| AzithromycinAlso: Group 2Azithromycin 500 mg once a day for 5 days. | Drug | Group 2 |
Primary outcome
Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative
Time frame: until 3 days
Clinical improvement measured by no sign \& symptom and RTPCR negative from baseline to Day 3
1 secondary outcome
Duration of hospitalization
Time frame: until 19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Favipiravir and Azithromycin in people with Infectious Disease and SARS-CoV Infection, run by Ina-Respond at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative (time frame: until 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.