Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 12
- 主要终点
- Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask.
研究概览
简要总结
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease.
During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection.
The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome.
The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
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
- •Age ≥ 18 years old,
- •Hospitalization for COVID-19 infection confirmed by RT-PCR or other virological method,
- •Peripheral saturation by pulse oximeter SpO2 ≤ 94% in ambient air measured twice at 5-15 min intervals, or PaO2 / FiO2 <300 mmHg,
- •Abnormalities on the chest x-ray or CT scan suggestive of viral pneumonia,
- •Signed informed consent by the patient.
排除标准
- •Covid-19 infection with first symptoms lasting for more than 9 days according to the patient's interview; D1 of symptoms is defined by the first day with fever, cough, shortness of breath, and / or chills related to Covid-19 infection;
- •Patients with primary or secondary immune deficiency, including: HIV, chronic hematological disease, solid organ transplant, ongoing immunosuppressive therapy,
- •Long-term corticosteroid therapy defined by a prescription of more than 10 mg/d (prednisone equivalent),
- •Suspected or confirmed infection with bacteria, fungal agents or viruses (in addition to Covid-19),
- •Known contraindication to systemic corticosteroids,
- •Systolic blood pressure <80 mmHg,
- •SpO2 <90% under 5 L / min of oxygen using medium concentration mask, or higher oxygen requirements,
- •Patient on long-term oxygen therapy,
- •Ongoing mechanical ventilation,
- •Ongoing septic shock ongoing,
- •Ongoing multi-organ failure ongoing,
- •Participating in other COVID-19 therapeutic clinical trial
- •Pregnant or breast-feeding woman (oral diagnosis),
- •No affiliation or beneficiary of health insurance,
研究组 & 干预措施
Prednisone group
Prednisone during 10 days after randomization
干预措施: Prednisone (Drug)
Control group
干预措施: Control group (Other)
结局指标
主要结局
Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask.
时间窗: 7 days
SpO2 \<90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.
次要结局
- disease severity assessed on a 7-level ordinal scale(7 days)
- number of patients with a supplemental oxygen use(7 days)
- radiological signs on chest imaging(7 days)
- number of patients transferred to intensive care unit(21 days)
- number of patients requiring invasive ventilation(21 days)
- Duration of oxygen therapy(21 days)
- number of adverse events induced by corticosteroid treatment(21 days)
- number of patients with infections other than SARS-CoV-2(21 days)
- number of deaths(21 days)