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| Column | Value |
|---|---|
| Trial registration number | NCT04981379 |
|
Full text link
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
2021-07-29 |
|
Recruitment status
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: volunteers who have understood all the procedures to be applied within the scope of the study protocol and gave their consent. patients between 18-60 years old. patients whose symptoms and complaints associated with covid-19 started within 48 hours. mild cases whose treatment to be given as outpatient. although asymptomatic, patients with high crp (> 20 mg/l) and/or lymphopenia (<1000/mm3) patients with symptoms such as fever, muscle/joint pain, cough, sore throat, nasal congestion, loss of smell. patients without serious underlying diseases (cardiovascular diseases, diabetes mellitus, hypertension, cancer, chronic lung diseases, immunosuppressive conditions) patients with normal chest x-ray and / or chest tomography (no sign of pneumonia) patients who accept oropharyngeal sample and venous blood collection at regular intervals within the scope of the protocol. patients who were not involved in any other interventional study. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
patients who do not give their consent in writing after informing. being under the age of 18 and over the age of 60. patients with a known history of allergy to one of the study drugs (hydroxychloroquine, favipiravir). volunteers who the researcher thinks may have problems with adherence to treatment. volunteers who will have trouble taking medication by mouth due to resistant nausea, vomiting or chronic diarrhea. patients with chronic liver disease and transaminase (alt or ast) levels 5 times the higher than the normal level. patients with heart disease or arrhythmia history. patients with gout or hyperuricemia. patients with signs of pneumonia in their lungs. patients with chronic renal failure (glomerular filtration rate <30). pregnant or breastfeeding patients. |
|
Number of arms
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Health Institutes of Turkey |
|
Inclusion age min
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
59 |
|
Countries
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Turkey |
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Type of patients
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
1120 |
|
primary outcome
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Worsening of clinical findings |
|
Notes
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1556, "treatment_name": "Favipiravir+hydroxychloroquine", "treatment_type": "Antivirals+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |