PROTECT-APT: Prophylaxis and Treatment of COVID-19

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04844541
• Collaborator: Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies (Other)
• Enrollment: 500
• Locations: 2
• Anticipated Duration (Months): 17.7
• Patients Per Site: 250
• Patients Per Site Per Month: 14.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 non-hospitalized populations and their 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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prophylaxis and Treatment of COVID-19 - Adaptive Platform Trial
• Actual Study Start Date: Jun 11, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Sub-population A Infected Cases Non-hospitalized symptomatic or asymptomatic SARS-CoV-2 infected adults or Non-hospitalized adults meeting the ILI case definition
Sub-population B Contacts Asymptomatic adult contacts of positive cases, defined as residing or working in the same household or shared or congregate living arrangement as a confirmed SARS-CoV-2 or ILI case

Outcome Measures

Primary Outcome Measures

1. Time-weighted average change in symptom score [12 Weeks]

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

2. Number of days with symptoms [12 Weeks]

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

Secondary Outcome Measures

1. Proportion of non-hospitalized ILI and SARS-CoV-2 infected adults seeking non-scheduled care for ILI and SARS-CoV-2 [12 Weeks]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

2. Time to clearance of SARS-CoV-2 in upper respiratory specimens of non-hospitalized ILI and SARS-CoV-2 infected adults [12 Weeks]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

3. Rate of change from the SARS-CoV-2 maximal viral load in non-hospitalized ILI and SARS-CoV-2 infected adults [28 Days]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

4. 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]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

5. Time-weighted average change from baseline viral load in SARS-CoV-2 uninfected adult contacts who become infected [14 Days]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

6. Change in modified ordinal outcome scale [12 Weeks]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

7. Time-weighted average change in lung fields with B lines using point of care lung ultrasound [12 Weeks]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

8. Change in SARS-CoV-2 IgM, IgG, and neutralizing antibodies from baseline [12 Weeks]

   Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations

Other Outcome Measures

1. Host gene expression levels that predict ILI or SARS-CoV-2 progression [12 Weeks]

   Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions

2. Host protein biomarkers that predict ILI or SARS-CoV-2 progression [12 Weeks]

   Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions

3. Immunophenotypes that predict ILI or SARS-CoV-2 progression [12 Weeks]

   Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions

4. Physiologic markers that predict ILI or SARS-CoV-2 progression [12 Weeks]

   Identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decisions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Population A: SARS-CoV-2 or ILI Cases

2. Age greater than or equal to 18 years old

3. Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within less than or equal to 5 days of enrollment

4. SARS-CoV-2 cases may be symptomatic or asymptomatic. If symptomatic, symptom onset (defined as presence of one or more COVID-19 symptoms listed below) within less than or equal to 5 days prior to enrollment

• Fever - subjective or measured (temperature greater than or equal to 38° C)

• Myalgias (body aches)

• Cough

• Sore Throat

• Headache

• Loss of taste or smell

• Nasal congestion or drainage

• Fatigue

• Shortness of breath

• Nausea, vomiting or diarrhea

OR

1. Age greater than or equal to 18 years old b. 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

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

2. Age greater than or equal to 18 years old

3. Asymptomatic contact, defined as residing or working in the same household or congregate living arrangement, as an individual (may be adult or child) with either:

• Symptomatic, laboratory confirmed SARS-CoV-2 infection OR

• Meeting the ILI case definition

1. Negative screening SARS-CoV-2 molecular or antigen diagnostic test

2. Exposure within 6 days or less from when the symptomatic, confirmed SARS-CoV-2 or ILI case first had symptoms

Exclusion Criteria:

1. Population A: SARS-CoV-2 or ILI Cases

2. 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

1. Laboratory confirmed SARS-CoV-2 infection 6 to 180 days prior to enrollment

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

1. Symptoms attributed to COVID-19 or ILI as assessed by a medical provider

2. Laboratory confirmed SARS-CoV-2 infection within 180 days of enrollment

3. Positive PCR test for acute respiratory infection including but not limited to influenza, RSV, adenovirus, parainfluenza virus, rhinovirus, metapneumovirus, Bordetella Pertussis, Chlamydia Pneumonia, coronavirus (other than SARS-CoV-2), mycoplasma within 7 days of enrollment

4. Hospital admission at the time of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287
2	Duke Global Health Institute	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine
• 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 Chair: Paul Blair, MD, Henry M. Jackson Foundation for the Advancement of Military Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
• ClinicalTrials.gov Identifier: NCT04844541
• Other Study ID Numbers: PC02
• First Posted: Apr 14, 2021
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine: Point-of-Care Ultrasound; Physiological Monitoring; At Home Blood Collection; Patient-Centric Devices
• Additional relevant MeSH terms: COVID-19; Respiratory Tract Infections

Study Results

No Results Posted as of Apr 14, 2022