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

Health Institutes of Turkey

Status and phase: Completed; Phase 3

Conditions: Covid19

Treatments: Drug: Placebo; Drug: Favipiravir; Drug: Hydroxychloroquine; Drug: Favipiravir + Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04981379

COVID-19-FAV-HQ

Details and patient eligibility

About

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.

Full description

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial in in adults aged 18~59 Years. The study was planned as a multicenter, randomized controlled, double-blind, parallel-arm drug study. The purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine, favipiravir, or hydroxychloroquine + favipiravir treatments that were initiated early in patients who were caught during filiation or who were decided to be outpatient due to mild disease findings during hospital admission, after the diagnosis of COVID-19 against patients with placebo. It is planned that the study will be conducted with two separate arms. Study arms are planned as 2:2:2:1 for 320:320:320:160 patients as follows. The dose of Favipiravir has been determined as the standard dose. Hydroxychloroquine will also be given without a loading dose.

Enrollment: 1,120 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,120 participants in 4 patient groups, including a placebo group

Hydroxychloroquine + Favipiravir

Active Comparator group

Description:

Hydroxychloroquine 2x200 mg 5 days and favipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)

Treatment:

Drug: Favipiravir + Hydroxychloroquine

Favipiravir + Placebo (Hydroxychloroquine)

Active Comparator group

Description:

Favipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine ) 2x200 mg (5 days)

Treatment:

Drug: Favipiravir

Hydroxychloroquine + Placebo (Favipiravir)

Active Comparator group

Description:

Hydroxychloroquine 2x200 mg (for 5 days) + placebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)

Treatment:

Drug: Hydroxychloroquine

Placebo (Favipiravir) + Placebo (Hydroxychloroquine)

Placebo Comparator group

Description:

Placebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine) 2x200 mg (5 days)

Treatment:

Drug: Placebo