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

Health Institutes of Turkey1,120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,120

Conditions

Covid19

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval + Placebo \[Favipiravir (1600 mg)\], as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval.

FavipiravirDRUG

Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Placebo \[Hydroxychloroquine (200 mg)\], as two tablets per day for 5-day interval.

Favipiravir + HydroxychloroquineDRUG

Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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.

Locations (6)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Başakşehir Çam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Istanbul University Istanbul Medicine Faculty

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Worsening of clinical findings

Worsening of clinical findings such as respiratory distress or persistence of fever, which require hospital admission to begin another treatment (for example, remdesivir, dexamethasone, anti-cytokines, etc.)

Time frame: During the study

Secondary Outcomes

Complete resolution of symptoms and signs

Time frame: Fifth day after examination

Complete resolution of symptoms and signs

Time frame: Tenth day after examination

Negative RT-PCR test for SARS-CoV-2

Negative RT-PCR test for SARS-CoV-2 virus

Time frame: Tenth day after examination

Determination of IgM, IgG levels for SARS-CoV-2

Determination of IgM, IgG levels for SARS-CoV-2 virus

Time frame: Tenth day after examination

Negative RT-PCR test for SARS-CoV-2

Negative RT-PCR test for SARS-CoV-2 on the 30th day visit

Time frame: Thirtieth day after examination

Determination of IgM, IgG antibodies

Determination of IgM, IgG antibodies against SARS-CoV-2

Time frame: Thirtieth day after examination

Development of signs of pneumonia

Data from ClinicalTrials.gov

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