CompletedNot Applicable

Prophylaxis and Treatment of COVID-19

United States, Thailand450 participantsStarted 2021-06-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. 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

Exclusion criteria

✕. Population A: Adults seeking care or testing for SARS-CoV-2 or ILI
✕. 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
✕. 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
✕. Absence of informed consent

What they're measuring

Time-weighted average change in symptom score

Timeframe: 12 Weeks

Number of days with symptoms

Timeframe: 12 Weeks

Trial details

NCT IDNCT04844541

SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-21

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