Efficacy and Safety of the Use of Hydroxychloroquine, Favipiravir or Hydroxychloroquine + Favipiravir in Early SARS-CoV-2 (COVID-19) Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,120
- 试验地点
- 6
- 主要终点
- Worsening of clinical findings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers who have understood all the procedures to be applied within the scope of the study protocol and gave their consent.
- •Patients between 18-60 years old.
- •Patients whose symptoms and complaints associated with COVID-19 started within 48 hours.
- •Mild cases whose treatment to be given as outpatient.
- •Although asymptomatic, patients with high CRP (> 20 mg/L) and/or lymphopenia (<1000/mm3)
- •Patients with symptoms such as fever, muscle/joint pain, cough, sore throat, nasal congestion, loss of smell.
- •Patients without serious underlying diseases (cardiovascular diseases, diabetes mellitus, hypertension, cancer, chronic lung diseases, immunosuppressive conditions)
- •Patients with normal chest x-ray and / or chest tomography (no sign of pneumonia)
- •Patients who accept oropharyngeal sample and venous blood collection at regular intervals within the scope of the protocol.
- •Patients who were not involved in any other interventional study.
排除标准
- •Patients who do not give their consent in writing after informing.
- •Being under the age of 18 and over the age of
- •Patients with a known history of allergy to one of the study drugs (hydroxychloroquine, favipiravir).
- •Volunteers who the researcher thinks may have problems with adherence to treatment.
- •Volunteers who will have trouble taking medication by mouth due to resistant nausea, vomiting or chronic diarrhea.
- •Patients with chronic liver disease and transaminase (ALT or AST) levels 5 times the higher than the normal level.
- •Patients with heart disease or arrhythmia history.
- •Patients with gout or hyperuricemia.
- •Patients with signs of pneumonia in their lungs.
- •Patients with chronic renal failure (glomerular filtration rate <30).
- •Pregnant or breastfeeding patients.
研究组 & 干预措施
Hydroxychloroquine + Favipiravir
Hydroxychloroquine 2x200 mg 5 days and favipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)
干预措施: Favipiravir + Hydroxychloroquine (Drug)
Favipiravir + Placebo (Hydroxychloroquine)
Favipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine ) 2x200 mg (5 days)
干预措施: Favipiravir (Drug)
Hydroxychloroquine + Placebo (Favipiravir)
Hydroxychloroquine 2x200 mg (for 5 days) + placebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)
干预措施: Hydroxychloroquine (Drug)
Placebo (Favipiravir) + Placebo (Hydroxychloroquine)
Placebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine) 2x200 mg (5 days)
干预措施: Placebo (Drug)
结局指标
主要结局
Worsening of clinical findings
时间窗: During the study
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.)
次要结局
- Determination of IgM, IgG antibodies(Thirtieth day after examination)
- The rate of discontinuation of treatments due to side effects(During the study)
- Complete resolution of symptoms and signs(Tenth day after examination)
- Determination of IgM, IgG levels for SARS-CoV-2(Tenth day after examination)
- Development of signs of pneumonia(During the study)
- Requirement of respiratory support with high flow oxygen(During the study)
- Requirement of mechanical ventilation(During the study)
- Requirement of respiratory support with oxygen mask(During the study)
- Death(During the study)
- Negative RT-PCR test for SARS-CoV-2(Thirtieth day after examination)
- Time to improvement of symptoms after the initiation of study drugs(During the study)