Sars-CoV2Phase 3NCT04411433
Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
A Phase 3 study testing Favipiravir (3200 mg + 1200 mg), Favipiravir (3600 mg + 1600 mg) and Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine in people with Sars-CoV2 and COVID-19, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Favipiravir (3200 mg + 1200 mg), Favipiravir (3600 mg + 1600 mg) and Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2020to 1 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18 to 70 years,
- Patients with symptoms and complaints consistent with possible or confirmed COVID- 19 observed within the last 5 days,
- Patients with uncomplicated possible or confirmed COVID-19:
- Symptoms such as fever, muscle aches, joint pain, cough, sore throat, nasal congestion, however no respiratory distress, no tachypnea or no SpO2 < 93%,
- Chest imaging (X-ray or CT chest) documented as normal
- Patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms):
Show all 10Show fewer
- Symptoms such as fever, muscle aches, joint pain, cough, sore throat, nasal congestion, as well as respiratory rate <30/min and SpO2 above 93% on room air,
- Chest imaging (X-ray or CT chest)-documented mild pneumonia symptoms
- Patients who were decided to isolate and treat because of COVID-19 in the hospital,
- Patients who have not been involved in any other interventional studies.
Who cannot join
- Patients considered as inappropriate for this study for any reason like noncompliance by the researcher,
- Patients with persisting refractory nausea, vomiting, chronic diarrhoea or chronic gastrointestinal disorders, inability to swallow the study drug which may affect adequate absorption,
- Patients with chronic liver disease: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the upper limit of normal (ULN),
- Patients with gout or hyperuricemia (above the ULN),
- Patients with severe pneumonia symptoms,
- Patients with known allergy to Favipiravir or for substances used in the study,
Show all 14Show fewer
- Patients did not receive specific antiviral drugs such as lopinavir/ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission.
- Patients with known chronic renal impairment/failure [creatinine clearance (CcCl) <30 mL/min],
- Pregnant and lactating women
- Patients undergoing cardiac ablation therapy
- Patients using antiarrhythmic drugs
- Patients actively receiving chemotherapy
- Acute immunosuppressed patients
- Patients undergoing psychosis therapy
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 Open-Label, Multicenter, Parallel-Group, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.
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).
The investigational product Favipiravir is an antiviral drug against RNA viruses and has been stated as effective for the treatment of COVID-19, first emerged from China, in various clinical studies. In February 2020, Favipiravir was used for the clinical treatment of COVID-19, has been shown to be more effective than the lopinavir / ritonavir combination in 80 people. In recent researches, the drug favipiravir is suggested that it may induce recovery in a short time in patients with COVID-19-mild type and decrease the treatment duration from 11 days to 4 days.
The investigational product hydroxychloroquine sulfate is a 4- aminoquinoline derivative and widely used for the treatment of many rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus in addition to its antimalarial effects. In vitro studies reported that hydroxychloroquine sulfate may be effective against many viruses, including SARS-CoV-2 in many in vitro experiments. Additionally, preliminary results of limited number of studies have been revealed that hydroxychloroquine sulfate reduces virus load and induces improvement in patients with COVID-19. This agent has been also suggested to be used in COVID-19 prophylaxis.
Until now, there is no official report on whether hydroxychloroquine combined with favipiravir show clinical activity against the new coronavirus, COVID-19, in Turkey. The main purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of Turkey population with COVID-19.
This study designed as an open-label, multicenter, parallel-group, randomized, phase III clinical drug trial.
A total of 1000 subjects aged between 18 to 70 years with symptoms and complaints consistent with possible or confirmed COVID-19 observed within the last 5 days and meet all eligibility criteria will participate in the study.
This study will be conducted in 14 sites.
- Being tested
- Favipiravir (3200 mg + 1200 mg), Favipiravir (3600 mg + 1600 mg), Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine, Favipiravir (3200 mg + 1200 mg) combined with Azithromycin, Hydroxychloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Favipiravir (3200 mg + 1200 mg)Drug
Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total).
The treatment duration may be extended up to 14 days with the evaluation of principle investigator.
Favipiravir (3600 mg + 1600 mg)Drug
Drug: Favipiravir (3600 mg + 1600 mg) Dosage and method of administration: in a regimen of 2x1800 mg (oral) loading dose on day-1 followed by 1600 mg maintenance dose (2x800 mg, 2 times daily) on day-2 to day-5 (5 days in total).
The treatment duration may be extended up to 14 days with the evaluation of principle investigator.
Favipiravir (3200 mg + 1200 mg) combined with HydroxychloroquineDrug
Hydroxychloroquine Dosage and method of administration: in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total).
Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator.
Favipiravir (3200 mg + 1200 mg) combined with AzithromycinDrug
Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total).
Favipiravir Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator.
Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (200 mg oral 2 times daily) on day-2 to day-5 (5 days in total).
Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (200 mg oral 2 times daily) throughout 5 days (5 days in total).
Hydroxychloroquine combined with AzithromycinDrug
Drug: Hydroxychloroquine combined with Azithromycin Hydroxychloroquine Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total).
Hydroxychloroquine Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (2x200 mg oral, 2 times daily) throughout 5 days (5 days in total).
Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total).
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir (3200 mg + 1200 mg) | Experimental | Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total).
The treatment duration may be extended up to 14 days with the evaluation of principle investigator. Receives: Drug: Favipiravir (3200 mg + 1200 mg) |
| Favipiravir (3600 mg + 1600 mg) | Experimental | Dosage and method of administration: in a regimen of 2x1800 mg (oral) loading dose on day-1 followed by 1600 mg maintenance dose (2x800 mg, 2 times daily) on day-2 to day-5 (5 days in total).
The treatment duration may be extended up to 14 days with the evaluation of principle investigator. Receives: Drug: Favipiravir (3600 mg + 1600 mg) |
| Favipiravir combined with Hydroxychloroquine | Experimental | Hydroxychloroquine Dosage and method of administration: in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total).
Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. Receives: Drug: Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine |
| Favipiravir combined with Azithromycin | Experimental | Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total).
Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. Receives: Drug: Favipiravir (3200 mg + 1200 mg) combined with Azithromycin |
| Hydroxychloroquine | Active comparator | Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (200 mg oral 2 times daily) on day-2 to day-5 (5 days in total).
Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (200 mg oral 2 times daily) throughout 5 days (5 days in total). Receives: Drug: Hydroxychloroquine |
| Hydroxychloroquine combined with Azithromycin | Active comparator | Hydroxychloroquine Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total).
Hydroxychloroquine Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (2x200 mg oral, 2 times daily) throughout 5 days (5 days in total).
Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total). Receives: Drug: Hydroxychloroquine combined with Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery (discharge)
The evaluation of recovery (discharge) period until 14th day after administration.
Measured: 14 days
Decrease in viral load
The evaluation of decrease in viral load until 14th day after administration.
Measured: 14 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: 14 days
Frequency of occurrence of lymphopenia from baseline
Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.
Measured: 14 days
Frequency of occurrence of thrombocytopenia from baseline
Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.
Measured: 14 days
Changes in alanine aminotransferase (ALT) levels from baseline
Clinical evaluation of ALT levels from baseline until the end of study.
Measured: 14 days
Changes in aspartate aminotransferase (AST) levels from baseline
Clinical evaluation of AST levels from baseline until the end of study.
Measured: 14 days
Changes in C-reactive protein (CRP) levels from baseline
Clinical evaluation of CRP levels from baseline until the end of study.
Measured: 14 days
Changes in level of D-dimer levels from baseline
Clinical evaluation of D-dimer levels from baseline until the end of study.
Measured: 14 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: 14 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: 14 days
Changes in blood pressure from baseline
Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.
Measured: 14 days
Changes in respiratory rate from baseline
Clinical evaluation of respiratory rate levels from baseline until the end of study.
Measured: 14 days
Changes in pulse oxymetry from baseline
Clinical evaluation of pulse oxymetry levels from baseline until the end of study.
Measured: 14 days
Changes in fever from baseline
Clinical evaluation of changes in fever from baseline until the end of study.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start8 May 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 Sars-CoV2Studies 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
- This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.
- Masking
- None (open label)
- Enrolment
- 1,008 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, SB Istanbul Education 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), Kocaeli Derince Education 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
- NCT04411433
- Sponsor's protocol ID
- COVID-19-FAV
- Status last verified
- Jan 2021
- First submitted
- 23 May 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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 Open-Label, Multicenter, Parallel-Group, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04411433
- Acronym / sponsor ID
- COVID-19-FAV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,008 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, SB Istanbul Education 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), Kocaeli Derince Education and Research Hospital, Istanbul University, Kayseri City Hospital
- Study start
- 8 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 2 Jun 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 is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.
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).
The investigational product Favipiravir is an antiviral drug against RNA viruses and has been stated as effective for the treatment of COVID-19, first emerged from China, in various clinical studies. In February 2020, Favipiravir was used for the clinical treatment of COVID-19, has been shown to be more effective than the lopinavir / ritonavir combination in 80 people. In recent researches, the drug favipiravir is suggested that it may induce recovery in a short time in patients with COVID-19-mild type and decrease the treatment duration from 11 days to 4 days.
The investigational product hydroxychloroquine sulfate is a 4- aminoquinoline derivative and widely used for the treatment of many rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus in addition to its antimalarial effects. In vitro studies reported that hydroxychloroquine sulfate may be effective against many viruses, including SARS-CoV-2 in many in vitro experiments. Additionally, preliminary results of limited number of studies have been revealed that hydroxychloroquine sulfate reduces virus load and induces improvement in patients with COVID-19. This agent has been also suggested to be used in COVID-19 prophylaxis.
Until now, there is no official report on whether hydroxychloroquine combined with favipiravir show clinical activity against the new coronavirus, COVID-19, in Turkey. The main purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of Turkey population with COVID-19.
This study designed as an open-label, multicenter, parallel-group, randomized, phase III clinical drug trial.
A total of 1000 subjects aged between 18 to 70 years with symptoms and complaints consistent with possible or confirmed COVID-19 observed within the last 5 days and meet all eligibility criteria will participate in the study.
This study will be conducted in 14 sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.
| Arm | Type | Receives |
|---|---|---|
| Favipiravir (3200 mg + 1200 mg) | Experimental | Drug: Favipiravir (3200 mg + 1200 mg)Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. |
| Favipiravir (3600 mg + 1600 mg) | Experimental | Drug: Favipiravir (3600 mg + 1600 mg)Dosage and method of administration: in a regimen of 2x1800 mg (oral) loading dose on day-1 followed by 1600 mg maintenance dose (2x800 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. |
| Favipiravir combined with Hydroxychloroquine | Experimental | Drug: Favipiravir (3200 mg + 1200 mg) combined with HydroxychloroquineHydroxychloroquine Dosage and method of administration: in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total). Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. |
| Favipiravir combined with Azithromycin | Experimental | Drug: Favipiravir (3200 mg + 1200 mg) combined with AzithromycinAzithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total). Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. |
| Hydroxychloroquine | Active comparator | Drug: HydroxychloroquineDosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (200 mg oral 2 times daily) on day-2 to day-5 (5 days in total). Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (200 mg oral 2 times daily) throughout 5 days (5 days in total). |
| Hydroxychloroquine combined with Azithromycin | Active comparator | Drug: Hydroxychloroquine combined with AzithromycinHydroxychloroquine Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total). Hydroxychloroquine Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (2x200 mg oral, 2 times daily) throughout 5 days (5 days in total). Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects aged between 18 to 70 years,
- Patients with symptoms and complaints consistent with possible or confirmed COVID- 19 observed within the last 5 days,
- Patients with uncomplicated possible or confirmed COVID-19:
- Patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms):
- Patients who were decided to isolate and treat because of COVID-19 in the hospital,
Key exclusion criteria (14 listed)
- Patients considered as inappropriate for this study for any reason like noncompliance by the researcher,
- Patients with persisting refractory nausea, vomiting, chronic diarrhoea or chronic gastrointestinal disorders, inability to swallow the study drug which may affect adequate absorption,
- Patients with chronic liver disease: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the upper limit of normal (ULN),
- Patients with gout or hyperuricemia (above the ULN),
- Patients with severe pneumonia symptoms,
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 |
|---|---|---|
| Favipiravir (3200 mg + 1200 mg)Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. | Drug | Favipiravir (3200 mg + 1200 mg) |
| Favipiravir (3600 mg + 1600 mg)Drug: Favipiravir (3600 mg + 1600 mg) Dosage and method of administration: in a regimen of 2x1800 mg (oral) loading dose on day-1 followed by 1600 mg maintenance dose (2x800 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. | Drug | Favipiravir (3600 mg + 1600 mg) |
| Favipiravir (3200 mg + 1200 mg) combined with HydroxychloroquineHydroxychloroquine Dosage and method of administration: in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total). Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. | Drug | Favipiravir combined with Hydroxychloroquine |
| Favipiravir (3200 mg + 1200 mg) combined with AzithromycinAzithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total). Favipiravir Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator. | Drug | Favipiravir combined with Azithromycin |
| HydroxychloroquineDosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (200 mg oral 2 times daily) on day-2 to day-5 (5 days in total). Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (200 mg oral 2 times daily) throughout 5 days (5 days in total). | Drug | Hydroxychloroquine |
| Hydroxychloroquine combined with AzithromycinDrug: Hydroxychloroquine combined with Azithromycin Hydroxychloroquine Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total). Hydroxychloroquine Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (2x200 mg oral, 2 times daily) throughout 5 days (5 days in total). Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total). | Drug | Hydroxychloroquine combined with Azithromycin |
Primary outcome
Time to recovery (discharge)
Time frame: 14 days
The evaluation of recovery (discharge) period until 14th day after administration.
Decrease in viral load
Time frame: 14 days
The evaluation of decrease in viral load until 14th day after administration.
13 secondary outcomes
Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
Time frame: 14 days
Frequency of occurrence of lymphopenia from baseline
Time frame: 14 days
Frequency of occurrence of thrombocytopenia from baseline
Time frame: 14 days
Changes in alanine aminotransferase (ALT) levels from baseline
Time frame: 14 days
Changes in aspartate aminotransferase (AST) levels from baseline
Time frame: 14 days
Changes in C-reactive protein (CRP) levels from baseline
Time frame: 14 days
Changes in level of D-dimer levels from baseline
Time frame: 14 days
Changes in prothrombin time (PT) values from baseline
Time frame: 14 days
Changes in partial thromboplastin time (PTT) values from baseline
Time frame: 14 days
Changes in blood pressure from baseline
Time frame: 14 days
Changes in respiratory rate from baseline
Time frame: 14 days
Changes in pulse oxymetry from baseline
Time frame: 14 days
Changes in fever from baseline
Time frame: 14 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 Sars-CoV2
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
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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?
A Phase 3 study testing Favipiravir (3200 mg + 1200 mg), Favipiravir (3600 mg + 1600 mg) and Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine in people with Sars-CoV2 and 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 10 inclusion and 14 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.
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?
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: 14 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.