Prophylaxis and Treatment of COVID-19

NCT04844541 | Completed

• 1 other identifier: PC02
• Study Type: observational
• Target: 450
• Locations: 2 countries
• Sites: 3

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.

Conditions

COVID-19; Acute Respiratory Infection

Keywords

Point-of-Care Ultrasound; Physiological Monitoring; At Home Blood Collection; Patient-Centric Devices

Outcome Measures

Primary Outcomes (2)

• Time-weighted average change in symptom score

  Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations

  12 Weeks

• Number of days with symptoms

  Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations

  12 Weeks

Secondary Outcomes (8)

• Proportion of ILI and SARS-CoV-2 infected adults seeking non-scheduled care for ILI and SARS-CoV-2

  12 Weeks

• Time to clearance of SARS-CoV-2 in upper respiratory specimens of ILI and SARS-CoV-2 infected adults

  12 Weeks

• Rate of change from the SARS-CoV-2 maximal viral load in ILI and SARS-CoV-2 infected adults

  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

  12 Weeks

• Time-weighted average change from baseline viral load in SARS-CoV-2 uninfected adult contacts who become infected

  14 Days

Other Outcomes (4)

• Host gene expression levels that predict ILI or SARS-CoV-2 progression

  12 Weeks

• Host protein biomarkers that predict ILI or SARS-CoV-2 progression

  12 Weeks

• Immunophenotypes that predict ILI or SARS-CoV-2 progression

  12 Weeks

Study Arms (2)

Sub-population A Infected Cases

Symptomatic SARS-CoV-2 infected adults or adults meeting the ILI case definition (hospitalized and non-hospitalized)

Sub-population B Contacts

Asymptomatic adult contacts of positive cases, defined as indoor exposure to the symptomatic case or cases within 6 feet (2 meters) for greater than or equal to 15 minutes over a 24-hour period without the use of personal protective equipment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population A. Infected Cases: Symptomatic SARS-CoV-2 infected adults or Adults meeting the ILI case definition Population B. Contacts: Asymptomatic adult contacts of positive cases, defined as indoor exposure to they symptomatic case or cases within 6 feet (2 meters) for greater than or equal to fifteen minutes over a 24-hour period without the use of personal protective equipment

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

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.
• For Both populations:
• Absence of informed consent
• Individuals who the study investigators believe are unable to comply with the requirements of the study

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies: collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Duke Global Health Institute

Durham, North Carolina, 27710, United States

Location

Royal Thai Army Clinical Research Center (RTA CRC)/Royal Thai Army-Armed Forces Research Institute of Medical Sciences (RTA-AFRIMS)/Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Nasal mucus

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Danielle Clark, PhD

  Henry M. Jackson Foundation for the Advancement of Military Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 14, 2021
• Study Start: June 11, 2021
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (2); TH (1)