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.
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.
Study Type
OBSERVATIONAL
Enrollment
450
Johns Hopkins University
Baltimore, Maryland, United States
Duke Global Health Institute
Durham, North Carolina, United States
Royal Thai Army Clinical Research Center (RTA CRC)/Royal Thai Army-Armed Forces Research Institute of Medical Sciences (RTA-AFRIMS)/Phramongkutklao Hospital
Bangkok, Thailand
Time-weighted average change in symptom score
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks
Number of days with symptoms
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks
Proportion of ILI and SARS-CoV-2 infected adults seeking non-scheduled care for ILI and SARS-CoV-2
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks
Time to clearance of SARS-CoV-2 in upper respiratory specimens of ILI and SARS-CoV-2 infected adults
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks
Rate of change from the SARS-CoV-2 maximal viral load in ILI and SARS-CoV-2 infected adults
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 28 Days
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
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks
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Time-weighted average change from baseline viral load in SARS-CoV-2 uninfected adult contacts who become infected
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 14 Days
Change in modified ordinal outcome scale
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks
Time-weighted average change in lung fields with B lines using point of care lung ultrasound
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks
Change in SARS-CoV-2 IgM, IgG, and neutralizing antibodies from baseline
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Time frame: 12 Weeks