A Randomized Clinical Trial Comparing 7 Days Treatment With Corticosteroids Versus Placebo for Early COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Hospital admission or death in the first 2 weeks after randomization
研究概览
简要总结
This trial is an interventional, randomized, placebo-controlled, adaptive clinical trial in outpatients with symptomatic microbiologically-confirmed SARS-CoV-2, in stable clinical condition, and increased levels of serum C-reactive protein. The hypothesis of this study is that early administration of prednisone for 7 days in patients with evidence of increased C-reactive protein will decrease the progression of COVID-19, prevent clinical deterioration, and hospital admission. Objectives: Primary Objective: To evaluate if early administration of corticosteroids in non-hospitalized participants with proven SARS-CoV-2 infection with compatible clinical symptoms and increased C-reactive protein can prevent hospital admission or early death
详细描述
The proposed trial is an interventional, randomized, placebo-controlled, adaptive clinical trial in outpatients with symptomatic microbiologically-confirmed SARS-CoV-2, in stable clinical condition, and increased levels of serum C-reactive protein.
Potential participants will be identified via Public Health after a diagnosis of SARS-CoV-2 infection is made either by positive nucleic acid testing or by antigen detection, from a nasal or pharyngeal swab. These study candidates will be asked for permission to be contacted. If this person agrees, a research collaborator will contact the potential participant by phone call. During this phone call, verbal informed consent to be included in the study will be requested.
After inclusion in the study, participants will be divided into two groups with the below follow-up outline:
-
Group 1 non-RCT: Asymptomatic participants (no symptoms of early COVID-19). These participants will be followed by phone call every 48 hours for 14 days. If asymptomatic participants develop clinical symptoms of early COVID-19 during follow-up (pre-symptomatic COVID-19), they will be transferred to Group 2. Otherwise, study for this group will end at the 14 days timepoint with the exception 20 participants who consent to partake in the pulmonary evaluation at 12 weeks (tertiary/exploratory objective, see sections 3.1 and 7.1).
-
Group 2 non-RCT: Participants with symptoms of early COVID-19 will undergo full follow-up every 48 hours for 4 visits (8 days) which will consist of:
-
Review of clinical symptoms by phone call.
-
Oxygen saturation.
-
C-reactive protein in blood.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Placebo-controlled
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.
- •Microbiologically-confirmed SARS-CoV-
- •Clinical symptoms compatible with COVID-19 for 14 days or less before randomization.
- •Oxygen saturation ≥ 95%.
- •Protein C-reactive in blood performed by point-of-care testing ≥ 20 mg/L.
- •Signed informed consent.
排除标准
- •Oxygen requirement at home due to chronic lung disease.
- •Patients with immunosuppression or immunosuppressive therapies defined as:
- •Cancer on active chemotherapy.
- •Stem cell transplant in the previous 6 months.
- •Neutrophil count < 1000 cells/mm
- •Chronic treatment with immunosuppressive therapy, except for low-dose (≤10 mg daily) prednisone or equivalent dose of other corticosteroids.
- •HIV-infected patients with CD4 < 200 x 106/L.
- •Diagnosis with primary immunodeficiencies.
- •Chronic liver damage Child-Pugh C.
- •Chronic underlying process with suspected life expectancy less than 12 weeks.
- •Uncontrolled diabetes mellitus at screening, defined as no blood glucose testing or any blood glucose level higher than 14 mmol/L (or 250 mg/dL) in the last 14 days.
- •Diagnosis of any form of psychosis without receiving appropriate treatment.
- •Pregnancy at time of randomization.
研究组 & 干预措施
Prednisone
Treatment adjusted by weight. Prednisone 25 mg capsules:
- ≤ 50kg = 2 capsules QD x 7 days (maximum dose = 50mg/day)
- 50 - 80kg = 3 capsules QD x 7 days (maximum dose = 75mg/day)
- > 80kg = 4 capsules QD x 7 days (maximum dose = 100mg/day)
干预措施: Prednisone (Drug)
Prednisone
Treatment adjusted by weight. Prednisone 25 mg capsules:
- ≤ 50kg = 2 capsules QD x 7 days (maximum dose = 50mg/day)
- 50 - 80kg = 3 capsules QD x 7 days (maximum dose = 75mg/day)
- > 80kg = 4 capsules QD x 7 days (maximum dose = 100mg/day)
干预措施: Point of Care testing device for C-reactive protein (Device)
Placebo
Capsules with the same appearance as Prednisone
干预措施: Point of Care testing device for C-reactive protein (Device)
结局指标
主要结局
Hospital admission or death in the first 2 weeks after randomization
时间窗: 14 days
Need to be admitted to hospital or death during the first 2 weeks after randomization
次要结局
- Hospitalization at 30 days(30 days)
- Serious adverse events at 30 days(30 days)
- Mortality at 30 days(30 days)
- Death at week 12(Week 12)
- Duration of symptoms(Week 12)