Prophylaxis and Treatment of COVID-19 (PROTECT-APT)

Prophylaxis and Treatment of COVID-19 - Adaptive Platform Trial

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Acute Respiratory Infection

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.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Royal Thai Army Clinical Research Center (RTA CRC)/Royal Thai Army-Armed Forces Research Institute of Medical Sciences (RTA-AFRIMS)/Phramongkutklao Hospital
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Global Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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
      • 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
   3. Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment
   4. Symptom onset ≤ 5 days prior to enrollment

   OR

   1. Age ≥ 18 years old
   2. 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

2. Population B: SARS-CoV-2 or ILI Contacts

   1. Age ≥ 18 years old

   2. 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
   3. For SARS-CoV-2 contacts: Negative screening SARS-CoV-2 molecular or antigen diagnostic test performed at screening or within ≤ 24 hours of enrollment
   4. Exposure and enrollment within 6 days or less from when the symptomatic, confirmed SARS-CoV-2 or ILI case first had symptoms

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.
      • Hospitalization for isolation or quarantine requirements or for social reasons will NOT constitute an exclusion criterion

For Both populations:

1. Absence of informed consent
2. Individuals who the study investigators believe are unable to comply with the requirements of the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Time-weighted average change from baseline viral load in SARS-CoV-2 uninfected adult contacts who become infected	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	14 Days
Change in modified ordinal outcome scale	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Time-weighted average change in lung fields with B lines using point of care lung ultrasound	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Change in SARS-CoV-2 IgM, IgG, and neutralizing antibodies from baseline	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Proportion of ILI and SARS-CoV-2 infected adults seeking non-scheduled care for ILI and SARS-CoV-2	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Time to clearance of SARS-CoV-2 in upper respiratory specimens of ILI and SARS-CoV-2 infected adults	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Rate of change from the SARS-CoV-2 maximal viral load in ILI and SARS-CoV-2 infected adults	Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations	28 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Host gene expression levels that predict ILI or SARS-CoV-2 progression	Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions	12 Weeks
Host protein biomarkers that predict ILI or SARS-CoV-2 progression	Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions	12 Weeks
Immunophenotypes that predict ILI or SARS-CoV-2 progression	Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions	12 Weeks
Physiologic markers that predict ILI or SARS-CoV-2 progression	Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions	12 Weeks

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
• Investigators: Study Chair: Danielle Clark, PhD, Henry M. Jackson Foundation for the Advancement of Military Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Point-of-Care Ultrasound; Physiological Monitoring; At Home Blood Collection; Patient-Centric Devices
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Respiratory Tract Infections
• Other Study ID Numbers: PC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No