Évaluationefficacité et tolérance d'Une médication à Base de Cosphérunate et d'un phytomédicament Antiviral Par Voie Orale en Comparaison Avec un Traitement à Base d'Hydroxychloroquine Chez Des Adultes Malades Covid-19 Sans Complications
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Virological clearance of throat swabs or lower respiratory tract secretions
研究概览
简要总结
The phase II clinical trial, with three arms and at rate of 10 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non inferiority test aimed to compare the efficacy and safety in add on to Azithromycin, an antimalarial drug, a treatment combination of the antimalrial drug with an antiviral phytomedicine versus Hydroxychloroquine in COVID-19 patients without complications.
During the treatment, viral clearance, adverse effects related to treatment, and symptoms progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied.
详细描述
The patient who has signed the informed consent for participation in the study will be immediately taken care of by the investigating clinicians. The clinician will determine the history of the disease and identify any clinical signs shown by the patient. Clinical data will be recorded in the patient's medical file. At the end of the clinical examination, the investigating clinician will draw up the report of the biological examinations.
Laboratory examinations will be carried out according to the procedures and method by accredited laboratories in Guinea (National Institute of Public Health; Hemorrhagic Fevers Laboratory; CREMS - Kindia Laboratory; Institut Pasteur de Guinée) for the diagnosis of COVID19.
After inclusion, patients are assigned by randomization into separate treatment arms with 10 patients per arm. They remain in these treatment arms for the duration of the trial, analysis, and follow-up activities. A random sequence will be generated and implemented so as to randomize.
The treatments will be made available to investigative clinicians by the Institute for Research and Development of Medicinal and Food Plants of Guinea.
All subjects meeting the inclusion criteria will benefit from an individual file which will include data relating to general information, the complete clinical examination and the paraclinical examination. The data will be coded, entered and processed using statistical software. Data entry quality control will be performed on all files. The selected patients are distributed randomly into 3 parallel arms, each arm having a different treatment modality.
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
- •eligible patients are symptomatic adults with COVID-19 confirmed by a positive Polymerase Chain Reaction test without complications
排除标准
- •any patient herpersensitive to hydroxychloroquine or under antimalarial treatment in the 2 weeks preceding inclusion;
- •any patient with a complication who must be taken care of in an Emergency or Intensive Care Unit;
- •any patient with other acute or chronic ilnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral the oral treatment;
- •any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion;
- •pregant women;
- •severe neurological manifestations.
结局指标
主要结局
Virological clearance of throat swabs or lower respiratory tract secretions
时间窗: day 3 to day 14
Virological clearance from admission to discharge at days 3, 6 and 14
次要结局
- Worsened conditions(day 1 to day 14)
- Adverse effects(day 1 to day 14)
- COVID-19 symptoms(day 1 to day 14)