Status:
COMPLETED
Prophylaxis and Treatment of COVID-19
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
Conditions:
COVID-19
Acute Respiratory Infection
Eligibility:
All Genders
18+ years
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- OR
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04844541
Start Date
June 11 2021
End Date
February 21 2024
Last Update
April 24 2025
Active Locations (3)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
2
Duke Global Health Institute
Durham, North Carolina, United States, 27710
3
Royal Thai Army Clinical Research Center (RTA CRC)/Royal Thai Army-Armed Forces Research Institute of Medical Sciences (RTA-AFRIMS)/Phramongkutklao Hospital
Bangkok, Thailand, 10400