Randomized Trial to Evaluate the Safety and Efficacy of Outpatient Treatments to Reduce the Risk of Worsening in Individuals With COVID-19 With Risk Factors (COVERAGE France)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 412
- 试验地点
- 10
- 主要终点
- Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event
研究概览
简要总结
In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.
详细描述
COVERAGE France is Multicenter, randomized, controlled clinical trial with for each drug :
- A safety study pilot phase.
- An efficacy study phase. The data collected during the pilot phase, combined with new external data that emerged during the period, will be used to position treatments for the efficacy phase.
- Pilot phase will evaluate the tolerance of experimental treatments for drugs given for the first time ("first in home-based care") in ambulatory individuals with COVID-19 with aggravating risk factors.
- Efficacy Phase: To estimate the effectiveness of experimental ambulatory treatments, compared to vitamin supplementation, in reducing the risk of hospitalization, oxygen therapy indication or death in ambulatory individuals with COVID-19 with aggravating risk factors.
The trial is a national platform with the vocation to open as many centers as possible, subject to criteria set by the Scientific Advisory Board.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical picture suggestive of COVID-19 dated 7 days or less.
- •Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.
- •Absence of criteria for hospitalization or oxygen therapy according to current recommendations.
- •greater than or equal to 60 years of age without any risk factor
- •or between 50 and 59 years of age and the presence of at least one of the following risk factors :
- •Arterial hypertension under treatment (all stages)
- •Obesity (BMI ≥30 kg/m2)
- •Diabetes under treatment (all types)
- •Ischemic heart disease (all stages)
- •Heart failure (all stages)
- •Stroke History
- •Chronic Obstructive Pulmonary Disease (all stages)
- •Stage 3 chronic renal failure (30 ≤ Estimated GFR < 60 mL/min/1.73 m²)
- •Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.
- •Immunodeficiency
- •of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids > 15 mg/d of prednisone equivalent taken for at least 2 months);
- •HIV infection with CD4<200/mm
- •Valid, ambulatory person, fully able to understand the issues of the trial
- •Beneficiary of a Social Security scheme
- •Signed informed consent
排除标准
- •Asymptomatic person
- •Inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship)
- •Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.
研究组 & 干预措施
Vitamins
Patients in this arm will receive a vitamin supplement ("AZINC forme et vitalité®") during 10 days
干预措施: Vitamins (Dietary Supplement)
Telmisartan
Patients in this arm will receive Telmisartan (Micardis® 20 mg) during 10 days
干预措施: Telmisartan (Drug)
interferon β-1b
Patients in this arm will receive interferon β-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
干预措施: interferon β-1b (Drug)
Ciclesonide
Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days
干预措施: Ciclesonide (Drug)
结局指标
主要结局
Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event
时间窗: From inclusion (day0) to day 14
Efficacy phase: hospitalization
时间窗: From inclusion (day0) to day 14
Proportion of participants who had an indication for hospitalization
Efficacy phase: oxygen therapy
时间窗: From inclusion (day0) to day 14
Proportion of participants who had an indication for oxygen therapy
Efficacy phase: Death
时间窗: From inclusion (day0) to day 14
Proportion of participants with an occurrence of death
次要结局
- Proportion of hospitalizations, overall and by cause, in each group(From inclusion (day0) to day 28)
- Proportion of participants with negative SARS-CoV-2 RT-PCR(day 7)
- Haematological markers evolution(from inclusion (day 0) to day 7)
- Proportion of intensive care hospitalizations, overall and by cause, in each group(From inclusion (day0) to day 28)
- Death and causes of death(From inclusion (day0) to day 28)
- Inflammatory markers evolution(from inclusion (day 0) to day 7)
- Adverse events(from inclusion (day 0) to day 28)
- Adverse reactions(from inclusion (day 0) to day 28)
- Acceptability of the treatment(from inclusion (day 0) to day 10)
- Oxygen saturation worsening(from inclusion (day 0) to day 28)
- Antibiotic consumption(from inclusion (day 0) to day 28)
- protocol follow-up(from inclusion (day 0) to day 10)