Prophylaxis and Treatment of COVID-19

COVID-19 Clinical Trial

— PROTECT-APT  

Official title:

Prophylaxis and Treatment of COVID-19 - Adaptive Platform Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04844541
• Other study ID #: PC02
• Status: Active, not recruiting
• Start date: June 11, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• COVID-19
• Respiratory Tract Infections

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

Countries where clinical trial is conducted

United States,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Time-weighted average change in symptom score	Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Primary	Number of days with symptoms	Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations	12 Weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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