PACTR202010781639956招募中3 期
The impact of COVID-19 treatment on the type, strength and duration of antibody and cellular immune responses in SARS-CoV-2 patients in sub-Saharan Africa
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- DNDi
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •From the Master study :
- •1.Male or female patients,
- •2.Adults over or equal to 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis.
- •3.COVID-19 confirmed by molecular biology for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening.
- •4.Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) over or equal to 94%.
- •5.Corrected QT interval (QTc – Bazett and Fridericia) < 480 msec on ECG.
- •6.Signed written consent from the patient or his/her representative.
- •7.Accepting and having the ability to be reached by telephone throughout the study.
- •8.Having designated a contact person who can be contacted in case of emergency.
- •For the Immuno Ancillary study
- •1.Able and willing to provide consent for the immunological ancillary study
- •2.Able and willing to perform all study visits for a duration of 12 months after treatment start
排除标准
- •From the Master Study
- •1.Abnormal physical examination findings:
- •respiratory rate over or equal to 25 per minute;
- •blood pressure < 90/60 mmHg or > 160/100 mmHg;
- •body weight < 45 kg for patients over or equal to 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis;
- •recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L).
- •2.Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •3.Feeling unwell for more than 7 days prior to screening.
- •4.Severe cardiopathy or history of arrhythmia, renal or liver insufficiency.
- •5.History of congenital or acquired long QT-interval, family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction, family history of sudden cardiac death, sudden cardiac death, bradycardia < 50 bpm.
- •6.Past history of retinopathy, such as spots or dark strings floating in the field of vision (floaters), blurred or fluctuating vision, impaired colour vision, dark or empty areas in vision.
- •7.History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
- •8.End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months.
- •9.Pregnancy based on urine pregnancy test at screening or breast-feeding, unless recommended by the Data and Safety Monitoring Board after the first interim analysis.
- •10.Prior treatment with. lopinavir/ritonavir within 29 days prior to screening except if patients are receiving the same regimen as planned in this study. Patients randomised to lopinavir/ritonavir will stop their current treatment and switch to the IP lopinavir/ ritonavir. If randomised to other arms, patients will continue their current treatment with lopinavir/ritonavir.
- •11.Prior treatment with hydroxychloroquine within 29 days prior to screening or on-going at screening.
研究者
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