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Prophylaxis and Treatment of COVID-19 | Clinical Trials | Clareo Health

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Prophylaxis and Treatment of COVID-19

Prophylaxis and Treatment of COVID-19 - Adaptive Platform Trial

NCT04844541•Henry M. Jackson Foundation for the Advancement of Military Medicine

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Population A: Symptomatic SARS-CoV-2 or ILI Cases (hospitalized and non- hospitalized)
•1. Age ≥ 18 years old
•2. 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
+20 more criteria

Exclusion Criteria

•1. 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
•2. Population B: Adult contacts of SARS-CoV-2 or ILI infected individuals
•1. Symptoms attributed to COVID-19 or ILI as assessed by a medical provider
•2. Positive molecular or antigen test for SARS-CoV-2 from any upper respiratory specimen within 90 days prior to enrollment
•3. 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
•4. 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
•5. 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.
+4 more criteria

Locations (3)

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

Key Dates

Start Date

June 11, 2021

Primary Completion Date

February 21, 2024

Completion Date

February 21, 2024

Last Updated

April 24, 2025

Enrollment

450

ACTUAL participants

Conditions

COVID-19Acute Respiratory Infection

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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RECRUITINGPHASE1

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

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COVID-19

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prophylaxis and Treatment of COVID-19

Inclusion Criteria

Exclusion Criteria

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