Acute Respiratory Infection, COVID-19
Conditions
Keywords
Point-of-Care Ultrasound, Physiological Monitoring, At Home Blood Collection, Patient-Centric Devices
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Population A: Symptomatic SARS-CoV-2 or ILI Cases (hospitalized and non- hospitalized) 1. Age ≥ 18 years old 2. Presence of one or more of the following symptoms at enrollment: * Stuffy or runny nose * Hoarse voice * Sore throat * Difficulty breathing * Cough * Fatigue (Low energy or tiredness) * Muscle or body aches * Headache * Fever (documented temperature \> 38°C \[100.4°F\]) or subjective fever * Chills or shivering * Feeling hot or feverish * Nausea * Vomiting * Diarrhea * Loss of smell * Loss of taste 3. Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment 4. Symptom onset ≤ 5 days prior to enrollment OR 1. Age ≥ 18 years old 2. 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 2. Population B: SARS-CoV-2 or ILI Contacts 1. Age ≥ 18 years old 2. 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 3. For SARS-CoV-2 contacts: Negative screening SARS-CoV-2 molecular or antigen diagnostic test performed at screening or within ≤ 24 hours of enrollment 4. Exposure and enrollment within 6 days or less from when the symptomatic, confirmed SARS-CoV-2 or ILI case first had symptoms
Exclusion criteria
1. 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 2. Population B: Adult contacts of SARS-CoV-2 or ILI infected individuals 1. Symptoms attributed to COVID-19 or ILI as assessed by a medical provider 2. Positive molecular or antigen test for SARS-CoV-2 from any upper respiratory specimen within 90 days prior to enrollment 3. 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 4. 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 5. 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: 1. Absence of informed consent 2. Individuals who the study investigators believe are unable to comply with the requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average change in symptom score | 12 Weeks | Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations |
| Number of days with symptoms | 12 Weeks | Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
| Time-weighted average change from baseline viral load in SARS-CoV-2 uninfected adult contacts who become infected | 14 Days | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
| Change in modified ordinal outcome scale | 12 Weeks | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
| Time-weighted average change in lung fields with B lines using point of care lung ultrasound | 12 Weeks | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
| Change in SARS-CoV-2 IgM, IgG, and neutralizing antibodies from baseline | 12 Weeks | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
| Proportion of ILI and SARS-CoV-2 infected adults seeking non-scheduled care for ILI and SARS-CoV-2 | 12 Weeks | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
| Time to clearance of SARS-CoV-2 in upper respiratory specimens of ILI and SARS-CoV-2 infected adults | 12 Weeks | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
| Rate of change from the SARS-CoV-2 maximal viral load in ILI and SARS-CoV-2 infected adults | 28 Days | Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physiologic markers that predict ILI or SARS-CoV-2 progression | 12 Weeks | Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions |
| Host gene expression levels that predict ILI or SARS-CoV-2 progression | 12 Weeks | Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions |
| Immunophenotypes that predict ILI or SARS-CoV-2 progression | 12 Weeks | Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions |
| Host protein biomarkers that predict ILI or SARS-CoV-2 progression | 12 Weeks | Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions |
Countries
Thailand, United States
Outcome results
None listed