COVID-19NCT04474457
Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age
An observational study of COVID-19, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Favipiravir
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2020to 1 Jun 2021
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1000 patients aged 15 years or older and diagnosed with COVID-19 who meet inclusion/exclusion criteria of the study and have decision of treatment with favipiravir .
Who may be able to join
- Male and female patients, diagnosed with Covid-19 disease who are 15 years of age or older at the time of enrollment
- Patients who have understood all study procedures that will be applied under the study protocol
- Patients with confirmed diagnosis of COVID-19 by PCR and/or other accepted methods and have a treatment decision with favipiravir
- Patients who will accept oropharyngeal sample and venous blood sample collection periodically within the scope of the study protocol
Who cannot join
- Patients who are pregnant or females who are breast feeding
- Patients under the age of 15
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, School of Medicine
Ankara
About this study
Official title: An ObservationaI Study to Evaluate the Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age Who Are Receiving Favipiravir
This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.
Read the detailed description
The clinical picture of 2019-nCoV disease is in a broad spectrum, which includes asymptomatic infection, a mild upper respiratory tract infection, respiratory failure, and even severe viral pneumonia with death. Although the mortality rate is not yet clear, the reported case-fatality risk was 11-14% during the initial studies which included patients with severe disease. The overall case fatality rate was reported as approximately 2%. In addition, most cases have resulted in a pneumonia requiring supplemental oxygen therapy and ventilator support. The alarming levels of spread and severity of COVID-19 caused a global emergency and this outbreak has been characterized as a pandemic by the World Health Organization (WHO).
Studies have suggested that investigational product favipiravir can improve the recovery of patients with mild disease and reduce the treatment duration from less than 11 days.
The main purpose of this study is to obtain efficacy and safety data for favipiravir use in the Turkish patient cohort diagnosed with COVID-19 and decided to be treated with "Favipiravir" before enrollment to this observational study. This study is designed as an observational drug study which will evaluate the safety and efficacy of favipiravir in patients and diagnosed with COVID-19 and older than 15 years of age.
This study is designed as an observational drug study to evaluate the safety and efficacy of favipiravir in patients diagnosed with COVID-19 and older than 15 years of age with a favipiravir treatment decision. Patients who have already had a routine favipiravir treatment decision or favipiravir treatment started will be included in this study.
A total of 1000 female and male patients aged 15 years or older will be included in the study. The planned observation duration for each patient is 7 days.
This study will be conducted in 14 sites.
- Conditions
- COVID-19
- Being tested
- Favipiravir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".
| Study group | Role | What they receive |
|---|---|---|
| COVID-19/Favipiravir | Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir". Receives: Drug: Favipiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery (discharge)
The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.
Measured: 7 days
Decrease in viral load
The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.
Measured: 7 days
Secondary outcomes (13)
Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
Number/characteristics of Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment due to study drug from baseline until the end of study.
Measured: 7 days
Frequency of occurrence of lymphopenia from baseline
Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.
Measured: 7 days
Frequency of occurrence of thrombocytopenia from baseline
Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.
Measured: 7 days
Changes in alanine aminotransferase (ALT) levels from baseline
Clinical evaluation of ALT levels from baseline until the end of study.
Measured: 7 days
Changes in aspartate aminotransferase (AST) levels from baseline
Clinical evaluation of AST levels from baseline until the end of study.
Measured: 7 days
Changes in C-reactive protein (CRP) levels from baseline
Clinical evaluation of CRP levels from baseline until the end of study.
Measured: 7 days
Changes in level of D-dimer levels from baseline
Clinical evaluation of D-dimer levels from baseline until the end of study.
Measured: 7 days
Changes in prothrombin time (PT) values from baseline
Clinical evaluation of PT values for blood to coagulate from baseline until the end of study.
Measured: 7 days
Changes in partial thromboplastin time (PTT) values from baseline
Clinical evaluation of PTT values for blood to coagulate from baseline until the end of study.
Measured: 7 days
Changes in blood pressure from baseline
Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.
Measured: 7 days
Changes in respiratory rate from baseline
Clinical evaluation of respiratory rate levels from baseline until the end of study.
Measured: 7 days
Changes in pulse oximetry from baseline
Clinical evaluation of pulse oximetry levels from baseline until the end of study.
Measured: 7 days
Changes in fever from baseline
Clinical evaluation of changes in fever from baseline until the end of study.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start11 Jun 2020
- Primary completion31 Dec 2020
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Turkey
- Sponsor type
- Other government
- Collaborators
- Hacettepe University, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Umraniye Education and Research Hospital, Istanbul Training and Research Hospital, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey, Tepecik Training and Research Hospital, Istanbul University - Cerrahpasa, Ankara University, Ankara City Hospital Bilkent, Ankara Training and Research Hospital, Ege University Hospital (Application and Research Center), Derince Training and Research Hospital, Istanbul University, Kayseri City Hospital
- Responsible party
- Principal investigator, Prof. Ates KARA, MD, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474457
- Sponsor's protocol ID
- COVID-19-PMS-FAV
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ObservationaI Study to Evaluate the Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age Who Are Receiving Favipiravir
- ClinicalTrials.gov ID
- NCT04474457
- Acronym / sponsor ID
- COVID-19-PMS-FAV
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Ministry of Health, TurkeyOther government
- Collaborators
- Hacettepe University, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Umraniye Education and Research Hospital, Istanbul Training and Research Hospital, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey, Tepecik Training and Research Hospital, Istanbul University - Cerrahpasa, Ankara University, Ankara City Hospital Bilkent, Ankara Training and Research Hospital, Ege University Hospital (Application and Research Center), Derince Training and Research Hospital, Istanbul University, Kayseri City Hospital
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 16 Jul 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.
This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.
Detailed description
The clinical picture of 2019-nCoV disease is in a broad spectrum, which includes asymptomatic infection, a mild upper respiratory tract infection, respiratory failure, and even severe viral pneumonia with death. Although the mortality rate is not yet clear, the reported case-fatality risk was 11-14% during the initial studies which included patients with severe disease. The overall case fatality rate was reported as approximately 2%. In addition, most cases have resulted in a pneumonia requiring supplemental oxygen therapy and ventilator support. The alarming levels of spread and severity of COVID-19 caused a global emergency and this outbreak has been characterized as a pandemic by the World Health Organization (WHO).
Studies have suggested that investigational product favipiravir can improve the recovery of patients with mild disease and reduce the treatment duration from less than 11 days.
The main purpose of this study is to obtain efficacy and safety data for favipiravir use in the Turkish patient cohort diagnosed with COVID-19 and decided to be treated with "Favipiravir" before enrollment to this observational study. This study is designed as an observational drug study which will evaluate the safety and efficacy of favipiravir in patients and diagnosed with COVID-19 and older than 15 years of age.
This study is designed as an observational drug study to evaluate the safety and efficacy of favipiravir in patients diagnosed with COVID-19 and older than 15 years of age with a favipiravir treatment decision. Patients who have already had a routine favipiravir treatment decision or favipiravir treatment started will be included in this study.
A total of 1000 female and male patients aged 15 years or older will be included in the study. The planned observation duration for each patient is 7 days.
This study will be conducted in 14 sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19/Favipiravir | – | Drug: FavipiravirTurkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir". |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1000 patients aged 15 years or older and diagnosed with COVID-19 who meet inclusion/exclusion criteria of the study and have decision of treatment with favipiravir .
Key inclusion criteria (4 listed)
- Male and female patients, diagnosed with Covid-19 disease who are 15 years of age or older at the time of enrollment
- Patients who have understood all study procedures that will be applied under the study protocol
- Patients with confirmed diagnosis of COVID-19 by PCR and/or other accepted methods and have a treatment decision with favipiravir
- Patients who will accept oropharyngeal sample and venous blood sample collection periodically within the scope of the study protocol
Key exclusion criteria (2 listed)
- Patients who are pregnant or females who are breast feeding
- Patients under the age of 15
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 |
|---|---|---|
| FavipiravirTurkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir". | Drug | COVID-19/Favipiravir |
Primary outcome
Time to recovery (discharge)
Time frame: 7 days
The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.
Decrease in viral load
Time frame: 7 days
The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.
13 secondary outcomes
Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
Time frame: 7 days
Frequency of occurrence of lymphopenia from baseline
Time frame: 7 days
Frequency of occurrence of thrombocytopenia from baseline
Time frame: 7 days
Changes in alanine aminotransferase (ALT) levels from baseline
Time frame: 7 days
Changes in aspartate aminotransferase (AST) levels from baseline
Time frame: 7 days
Changes in C-reactive protein (CRP) levels from baseline
Time frame: 7 days
Changes in level of D-dimer levels from baseline
Time frame: 7 days
Changes in prothrombin time (PT) values from baseline
Time frame: 7 days
Changes in partial thromboplastin time (PTT) values from baseline
Time frame: 7 days
Changes in blood pressure from baseline
Time frame: 7 days
Changes in respiratory rate from baseline
Time frame: 7 days
Changes in pulse oximetry from baseline
Time frame: 7 days
Changes in fever from baseline
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
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?
Time to recovery (discharge) (time frame: 7 days). The study lists 2 primary outcomes in all. 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 1 Feb 2021.