Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Turkey
• Collaborators: Ankara City Hospital Bilkent; Ankara Training and Research Hospital; Ankara University; Ege University Hospital (Application and Research Center); Hacettepe University, Faculty of Medicine; Istanbul University; Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine; Istanbul University, Istanbul Faculty of Medicine; Kayseri City Hospital; Kocaeli Derince Education and Research Hospital; Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization; SB Istanbul Education and Research Hospital; Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey; Tepecik Training and Research Hospital; Umraniye Education and Research Hospital
• Treatments: Azithromycin; Favipiravir; Hydroxychloroquine

Criteria

Inclusion Criteria:

• 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:

1. Symptoms such as fever, muscle aches, joint pain, cough, sore throat, nasal congestion, however no respiratory distress, no tachypnea or no SpO2 < 93%,

2. Chest imaging (X-ray or CT chest) documented as normal

• Patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms):

1. 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,

2. 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 Criteria:

• 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