Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- SARS-CoV-2 viral load level
研究概览
简要总结
COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019. A rapid spread of the disease has occurred at a global scale, associated with a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt and the first case in Senegal was declared on March 2nd, 2020.
In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and safety, among adults, of different therapeutic regimens considered optimal according to current knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological, virologic and immunological characteristics of the infection. The protocol of the cohort is based and adapted from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol (CCP).
The Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe COVID-19 cases.
详细描述
COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019. A rapid spread of the disease has occurred at a global scale, associated with a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt and the first case in Senegal was declared on March 2nd, 2020.
In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and tolerance, among adults, of different therapeutic options considered optimal according to current knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological, virologic and immunological characteristics of the infection. The protocol of the cohort is based and adapted from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol (CCP).
The Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe COVID-19 cases. Its efficacy and safety will be evaluated against the standard of care used in Senegal.
The primary objective is to :
Evaluate and compare viral clearance between the different therapeutic interventions.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed cases of SARS-CoV-2 infection hospitalized in reference services identified by the Ministry of Health and Social Action of Senegal
- •Adults (≥18 years)
- •Full understanding and consent to participate to the trial
- •No contraindications to taking the tested treatments
- •Clinical status from 3 to 5 on the seven-category ordinal scale
- •Pneumonia highlighted by infiltration of the lungs by chest CT scan or chest radiography
- •Absence of contraindications to radiographic examinations (X-ray and/or CT scan) for diagnosis and/or follow-up
- •Inclusion in the 72 hours following the radiological pneumonia confirmation
- •Non-inclusion Criteria:
- •Pregnant or breastfeeding woman
- •Patient at high risk of death within 3 days of inclusion, in the clinician's opinion
- •Corrected QT interval (QTc) >500ms
- •Heart electrical dysfunction: atrioventricular block Mobitz type II second-degree, high-grade or complete without a functioning pacemaker
- •Uncontrolled and clinically significant heart diseases, such as arrhythmia, angina or decompensated congestive heart failure
- •Kidney failure (Cl < 30 mL/min)
- •Patients with liver cirrhosis whose Child-Puch score is B or C
- •Patients who have liver disease abnormalities with ALT or AST > 5 times ULN
- •Patients who have a known HIV status
- •Patients who have other clinically-important diseases in decompensation which may interfere with the evaluation or completion of the tested treatment's procedure, in the clinician's opinion
- •Patients with a clinical or psychological condition which, in the clinician's opinion, does not allow adequate evaluation of the tested treatment
- •Known allergy to the studied treatment regimen
- •Other contraindications with the studied treatment regimen
- •Known drug-drug interaction with a treatment usually taken by the participant contraindicating one of the studied treatment regimen
排除标准
- 未提供
研究组 & 干预措施
Standard of Care + Nafamostat mesilate
- The Standard of Care is the treatment which is the most adapted to the patient in the clinician's opinion. It could include the combination of Hydroxychloroquine and Azithromycin in the absence of contraindication.
- Nafamostat mesilate
干预措施: Nafamostat Mesilate (Drug)
结局指标
主要结局
SARS-CoV-2 viral load level
时间窗: Day 7
Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample
次要结局
- Length of hospitalization(through hospitalization, an average of 2 weeks)
- Vital status(Day 15)
- Clinical status on the seven-category ordinal scale(through hospitalization, an average of 2 weeks)
- Proportion of patients with serious adverse events reported during the clinical trial.(through study completion, an average of 7 months)
- Length of hospitalization in a resuscitation unit(through hospitalization, an average of 2 weeks)
- Maximum quick SOFA (qSOFA) score during hospitalisation(through hospitalization, an average of 2 weeks)
- Duration of oxygen therapy(through hospitalization, an average of 2 weeks)