Prophylaxis and Treatment of COVID-19 - Adaptive Platform Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- Time-weighted average change in symptom score
研究概览
简要总结
An observation study evaluating physiologic responses and host biomarker expression patterns in early SARS-CoV-2 and acute respiratory infections (ARI) and among their close contacts.
详细描述
The aim of this observational study is to characterize the clinical, biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 infection in cases and their close contacts. The incorporation of novel technologies including self-specimen collection, symptom self-reporting, remote physiologic monitoring and virtual interaction with participants will enhance the capacity to conduct remote clinical trial activities. Inclusion of these remote and virtual elements into clinical trials augment the capacity to conduct much needed clinical research during times of resource strain such as a global pandemic. PROTECT-APT will be conducted as a multi-site study coordinated centrally by the Henry M Jackson Foundation for the Advancement of Military Medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Population A: Symptomatic SARS-CoV-2 or ILI Cases (hospitalized and non- hospitalized)
- •Age ≥ 18 years old
- •Presence of one or more of the following symptoms at enrollment:
- •Stuffy or runny nose
- •Hoarse voice
- •Sore throat
- •Difficulty breathing
- •Fatigue (Low energy or tiredness)
- •Muscle or body aches
- •Fever (documented temperature > 38°C [100.4°F]) or subjective fever
- •Chills or shivering
- •Feeling hot or feverish
- •Loss of smell
- •Loss of taste
- •Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment
- •Symptom onset ≤ 5 days prior to enrollment
- •Age ≥ 18 years old
- •Meets the World Health Organization ILI case definition: An acute respiratory illness with a measured temperature of ≥ 38° C and cough, with onset within the past 10 days
- •Population B: SARS-CoV-2 or ILI Contacts
- •Age ≥ 18 years old
- •Asymptomatic contact of an individual with laboratory confirmed SARS-CoV-2 infection or an individual meeting the ILI case definition defined as:
- •Indoor exposure to the symptomatic case or cases within 6 feet (2 meters) for ≥ 15 minutes over a 24-hour period without the use of personal protective equipment
- •For SARS-CoV-2 contacts: Negative screening SARS-CoV-2 molecular or antigen diagnostic test performed at screening or within ≤ 24 hours of enrollment
- •Exposure and enrollment within 6 days or less from when the symptomatic, confirmed SARS-CoV-2 or ILI case first had symptoms
排除标准
- •Population A: Adults seeking care or testing for SARS-CoV-2 or ILI
- •a. Laboratory confirmed SARS-CoV-2 infection 6 to 90 days prior to enrollment
- •Population B: Adult contacts of SARS-CoV-2 or ILI infected individuals
- •Symptoms attributed to COVID-19 or ILI as assessed by a medical provider
- •Positive molecular or antigen test for SARS-CoV-2 from any upper respiratory specimen within 90 days prior to enrollment
- •SARS-CoV-2 vaccination within 90 days prior to enrollment EXCEPT if severely immunocompromised or a known vaccine non-responder
- •Severely immunocompromised or a known vaccine non-responder defined as: solid organ or stem cell recipient, B cell leukemia, receiving B cell depletion therapy (e.g., rituximab), agammaglobulinemia, or negative serology ≥ 2 weeks after vaccination with two doses of a vaccine
- •Positive PCR test for acute respiratory infection including but not limited to influenza, RSV, adenovirus, parainfluenza virus, rhinovirus, metapneumovirus, Bordatella Pertussis, Chlamydia Pneumonia, coronavirus (other than SARS-CoV-2), mycoplasma within 7 days of enrollment
- •Hospital admission at the time of enrollment
- •Hospitalization will be defined as requiring medical care not available in an outpatient setting for greater than 24 hours.
- •Hospitalization for isolation or quarantine requirements or for social reasons will NOT constitute an exclusion criterion
- •For Both populations:
- •Absence of informed consent
- •Individuals who the study investigators believe are unable to comply with the requirements of the study
结局指标
主要结局
Time-weighted average change in symptom score
时间窗: 12 Weeks
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
Number of days with symptoms
时间窗: 12 Weeks
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
次要结局
- Time to clearance of SARS-CoV-2 in upper respiratory specimens of ILI and SARS-CoV-2 infected adults(12 Weeks)
- Rate of change from the SARS-CoV-2 maximal viral load in ILI and SARS-CoV-2 infected adults(28 Days)
- Time-weighted average change from baseline viral load in SARS-CoV-2 uninfected adult contacts who become infected(14 Days)
- Change in modified ordinal outcome scale(12 Weeks)
- Proportion of ILI and SARS-CoV-2 infected adults seeking non-scheduled care for ILI and SARS-CoV-2(12 Weeks)
- Proportion of lab confirmed infections (e.g., SARS-CoV-2, influenza, coronavirus except SARS-CoV-2, RSV, parainfluenza, adenovirus, rhinovirus, metapneumovirus, B. Pertussis, C. Pneumonia, mycoplasmas) in uninfected adult contacts(12 Weeks)
- Time-weighted average change in lung fields with B lines using point of care lung ultrasound(12 Weeks)
- Change in SARS-CoV-2 IgM, IgG, and neutralizing antibodies from baseline(12 Weeks)