Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
Sars-CoV2, COVID-19
About this trial
This is an interventional treatment trial for Sars-CoV2
Eligibility 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:
- 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 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
Sites / Locations
- Hacettepe University, School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Favipiravir (3200 mg + 1200 mg)
Favipiravir (3600 mg + 1600 mg)
Favipiravir combined with Hydroxychloroquine
Favipiravir combined with Azithromycin
Hydroxychloroquine
Hydroxychloroquine combined with Azithromycin
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: 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.
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.
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.
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 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).