COVID-19PROTECT-APTNCT04844541
Prophylaxis and Treatment of COVID-19
An observational study of COVID-19 and Acute Respiratory Infection, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Acute Respiratory Infection
- How many people
- 450 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Jun 2021to 21 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
- Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment
- Symptom onset ≤ 5 days prior to enrollment
- OR
- Age ≥ 18 years old
- 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
- Population B: SARS-CoV-2 or ILI Contacts
- Age ≥ 18 years old
- 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
- For SARS-CoV-2 contacts: Negative screening SARS-CoV-2 molecular or antigen diagnostic test performed at screening or within ≤ 24 hours of enrollment
- Exposure and enrollment within 6 days or less from when the symptomatic, confirmed SARS-CoV-2 or ILI case first had symptoms
Who cannot join
- Population A: Adults seeking care or testing for SARS-CoV-2 or ILI
- 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
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- 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.
- Hospitalization for isolation or quarantine requirements or for social reasons will NOT constitute an exclusion criterion
- For Both populations:
- Absence of informed consent
- Individuals who the study investigators believe are unable to comply with the requirements of the study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Duke Global Health Institute
Durham, North Carolina, 27710
Thailand1 site
Royal Thai Army Clinical Research Center (RTA CRC)/Royal Thai Army-Armed Forces Research Institute of Medical Sciences (RTA-AFRIMS)/Phramongkutklao Hospital
Bangkok, 10400
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Acute Respiratory Infection
- Keywords
- Point-of-Care Ultrasound, Physiological Monitoring, At Home Blood Collection, Patient-Centric Devices
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average change in symptom score
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
Measured: 12 Weeks
Number of days with symptoms
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
Measured: 12 Weeks
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Describe the biological, virological, immunological, and pathological characteristics of ILI and SARS-CoV-2 in the target populations
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start11 Jun 2021
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
- Responsible party
- Sponsor
- Investigators
- Danielle Clark, PhD, Study chair, Henry M. Jackson Foundation for the Advancement of Military Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844541
- Sponsor's protocol ID
- PC02
- Acronym
- PROTECT-APT
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis and Treatment of COVID-19 - Adaptive Platform Trial
- ClinicalTrials.gov ID
- NCT04844541
- Acronym / sponsor ID
- PROTECT-APT / PC02
- Conditions
- COVID-19, Acute Respiratory Infection
- Keywords
- Point-of-Care Ultrasound, Physiological Monitoring, At Home Blood Collection, Patient-Centric Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (30 listed)
- Population A: Symptomatic SARS-CoV-2 or ILI Cases (hospitalized and non- hospitalized)
- OR
- Population B: SARS-CoV-2 or ILI Contacts
Key exclusion criteria (14 listed)
- Population A: Adults seeking care or testing for SARS-CoV-2 or ILI
- Population B: Adult contacts of SARS-CoV-2 or ILI infected individuals
- Absence of informed consent
- Individuals who the study investigators believe are unable to comply with the requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time-weighted average change in symptom score
Time frame: 12 Weeks
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
Number of days with symptoms
Time frame: 12 Weeks
Describe the clinical characteristics of ILI and SARS-CoV-2 in the target populations
8 secondary outcomes
Proportion of ILI and SARS-CoV-2 infected adults seeking non-scheduled care for ILI and SARS-CoV-2
Time frame: 12 Weeks
Time to clearance of SARS-CoV-2 in upper respiratory specimens of ILI and SARS-CoV-2 infected adults
Time frame: 12 Weeks
Rate of change from the SARS-CoV-2 maximal viral load in ILI and SARS-CoV-2 infected adults
Time frame: 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
Time frame: 12 Weeks
Time-weighted average change from baseline viral load in SARS-CoV-2 uninfected adult contacts who become infected
Time frame: 14 Days
Change in modified ordinal outcome scale
Time frame: 12 Weeks
Time-weighted average change in lung fields with B lines using point of care lung ultrasound
Time frame: 12 Weeks
Change in SARS-CoV-2 IgM, IgG, and neutralizing antibodies from baseline
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Clark, PhD study chair
Henry M. Jackson Foundation for the Advancement of Military Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Acute Respiratory Infection, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average change in symptom score (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.