Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment

• Status: Completed
• Trial end date: 2021-02-16
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial which aims to investigate the superiority of hydroxychloroquine, favipiravir or hydroxychloroquine + favipiravir treatment, initiated especially in the early period in the treatment of COVID-19, over the patients being followed up with placebo in adults aged 18~59 Years.

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

Details

• Lead Sponsor: Health Institutes of Turkey
• Treatments: Favipiravir; Hydroxychloroquine

Criteria

Inclusion Criteria:

1. Volunteers who have understood all the procedures to be applied within the scope of the study protocol and gave their consent.

2. Patients between 18-60 years old.

3. Patients whose symptoms and complaints associated with COVID-19 started within 48 hours.

4. Mild cases whose treatment to be given as outpatient.

1. Although asymptomatic, patients with high CRP (> 20 mg/L) and/or lymphopenia (<1000/mm3)

2. Patients with symptoms such as fever, muscle/joint pain, cough, sore throat, nasal congestion, loss of smell.

3. Patients without serious underlying diseases (cardiovascular diseases, diabetes mellitus, hypertension, cancer, chronic lung diseases, immunosuppressive conditions)

4. Patients with normal chest x-ray and / or chest tomography (no sign of pneumonia)

5. Patients who accept oropharyngeal sample and venous blood collection at regular intervals within the scope of the protocol.

6. Patients who were not involved in any other interventional study.

Exclusion Criteria:

1. Patients who do not give their consent in writing after informing.

2. Being under the age of 18 and over the age of 60.

3. Patients with a known history of allergy to one of the study drugs (hydroxychloroquine, favipiravir).

4. Volunteers who the researcher thinks may have problems with adherence to treatment.

5. Volunteers who will have trouble taking medication by mouth due to resistant nausea, vomiting or chronic diarrhea.

6. Patients with chronic liver disease and transaminase (ALT or AST) levels 5 times the higher than the normal level.

7. Patients with heart disease or arrhythmia history.

8. Patients with gout or hyperuricemia.

9. Patients with signs of pneumonia in their lungs.

10. Patients with chronic renal failure (glomerular filtration rate <30).

11. Pregnant or breastfeeding patients.