Prophylaxis and Treatment of COVID-19
Completed
Conditions studied: COVID-19, Acute Respiratory Infection
In brief
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.
Key facts
- Study ID
- NCT04844541
- Run by
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- People needed
- 450
- Starts
- 2021-06-11
- Expected to finish
- 2024-02-21
- Last updated by the study team
- 2025-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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