Status:
UNKNOWN
Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
Lead Sponsor:
Ministry of Health, Turkey
Collaborating Sponsors:
Hacettepe University
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Conditions:
Sars-CoV2
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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):
- 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.
Exclusion
- 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,
- 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
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
1008 Patients enrolled
Trial Details
Trial ID
NCT04411433
Start Date
May 8 2020
End Date
June 1 2021
Last Update
February 1 2021
Active Locations (1)
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1
Hacettepe University, School of Medicine
Ankara, Turkey (Türkiye)