SARS-CoV-2Phase 2PROTECT-APT 1NCT05954286
PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19
A Phase 2 study testing Upamostat in people with SARS-CoV-2, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 6 sites in 4 countries.
Trial summary
This study is an adaptive, randomized, double blind, platform trial evaluating promising investigational products (IP) for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Upamostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 29 Jan 2024to 24 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age ≥ 18 years
- Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment
- Presence of two or more Screening Symptoms listed in Supplement 3 with at least two symptoms classified as moderate to severe (and/or ≥ 2 on the frequency questions or loss of taste/smell questions) at the time of enrollment a. For participants who have preexisting conditions causing mild or moderate symptoms listed on the Screening Symptom Questionnaire, there must be an increase of at least one severity level for that symptom at enrollment (For example, prior to illness participant routinely experienced headaches rated as moderate severity, now rating headache as severe at enrollment)
- Supplement 3 Screening Symptoms: 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
- Symptom onset ≤ 5 days prior to enrollment
- Age ≥ 18 years
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- Asymptomatic contact of an individual with laboratory confirmed SARS-CoV-2 infection 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
- Negative screening SARS-CoV-2 molecular or antigen diagnostic test performed at screening or within less than or equal to 24 hours of enrollment
- Exposure and enrollment within 6 days or less from when the symptomatic, confirmed SARS-CoV-2 positive case first had symptoms
- 1. Must also meet the intervention specific inclusion/exclusion criteria for at least one PSA that is enrolling participants
- 1. Women of childbearing potential must agree to use an effective contraceptive method upon enrollment in the study through 8 weeks after the last dose of the investigational product. This would include oral contraceptives, implanted contraceptives, intrauterine devices, and barrier methods.
- A woman is considered of childbearing potential unless post-menopausal (subject is at least 50 years old and has a history of ≥ 2 years without menses without other known or suspected cause), or permanently surgically sterilized.
- Participants not of reproductive potential are eligible without requiring the use of a contraceptive method. Participant-reported history is acceptable documentation of surgical sterilization and menopause.
Who cannot join
- 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
- Laboratory confirmed SARS-CoV-2 infection 6 to 90 days prior to enrollment
- Oxygen saturation < 92% on room air
- Baseline use of supplemental oxygen at the time of enrollment
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- Presence of any of the following comorbidities that per the PI puts the patient at high risk of developing severe COVID-19 illness:
- Age ≥ 75 years b. Active treatment for solid tumor and hematologic malignancies c. Hematologic malignancy, myeloma, or related disorder (e.g., myelodysplastic syndrome, myelofibrosis) d. Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy e. Chemotherapy or radiotherapy for solid organ cancer in the last 12 months f. Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy) g. Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome) h. Advanced or untreated HIV infection (people with HIV and CD4 cell counts less than 200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) i. Active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory j. Sickle cell disease k. Chronic liver disease (e.g., Child-Pugh Class A, B or C cirrhosis) l. Down syndrome m. Dementia or neurocognitive disability (e.g., Parkinson's disease) n. Participants with 3 or more of the following conditions: i) No prior COVID-19 infection OR has not completed a COVID-19 vaccine series within the last 6 months OR has not received a vaccine booster within the last 6 months ii) Age 65-74 years iii) BMI ≥35 (or >95th percentile in adolescents) iv) Type 1 or type 2 diabetes mellitus v) Cardiovascular disease (including HTN if age >55) vi) Chronic lung disease (including bronchiectasis, CF, COPD, ILD, PHTN, PE, moderate-to-severe asthma) vii) Chronic kidney disease (eGFR <30)
- Participants who are receiving or plan to receive anti-SARS-CoV-2 antivirals for treatment of their COVID-19
- Population B: Uninfected adult contacts of symptomatic SARS-CoV-2 infected individuals
- 1. Symptoms attributed to COVID-19 as assessed by the investigator 2. Positive molecular or antigen diagnostic 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 4. Severely immunocompromised or a known vaccine non-responder defined as: solid organ or stem cell transplant 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 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 6. Hospitalization for isolation or quarantine requirements or for social reasons will NOT constitute an exclusion criterion
- For Both populations:
- Absence of informed consent
- Pregnancy
- Breastfeeding
- Individuals who the study investigators believe are unable to comply with the requirements of the study
- Participation in another intervention trial for the treatment or prophylaxis of SARS-CoV-2 infection or COVID-19 disease at the time of enrollment
- Additional Criteria for the Early Treatment Upamostat Arm:
- 1. Patient is currently taking or is expected to start taking warfarin, apixaban (Eliquis), or rivaroxaban (Xarelto). Patients may be taking or start on study dabigatran (Pradaxa), standard or low molecular weight heparin.
- 2. Patients with prolonged QT/QTc interval and/or increased susceptibility to arrythmia defined as the presence of any of the following:
- QTc interval > 450 msec
- Pathological Q-waves (defined as Q-wave > 40 msec or depth > 0.4-0.5 mV)
- Evidence of ventricular pre-excitation
- Electrocardiographic evidence of complete LBBB, RBBB, incomplete LBBB, in complete RBBB
- Evidence of second- or third-degree heart block
- Intraventricular conduction delay with QRS duration > 120 msec
- Bradycardia as defined by sinus rate< 50 bpm
- Personal or family history of long QT syndrome
- Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, except for sinus arrhythmia
- Syncopal episodes or additional risk factors for torsades de points (e.g., heart failure, hypokalemia)
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
KUR Research
Nashville, Tennessee, 37209
Thailand1 site
Royal Thai Army Clinical Research Center (RTA CRC) Royal Thai Army-Armed Forces Research Institute of Medical Sciences (RTA-AFRIMS)
Bangkok, 10400
About this study
Official title: Master Protocol for Early Treatment and Post-Exposure Prophylaxis of COVID-19 Adaptive Platform Trial PROTECT-APT 1
This study is an adaptive, randomized, double blind, platform trial evaluating promising investigational products (IP) for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Read the detailed description
This multicenter trial will be conducted in both domestic and international sites. The study will compare IPs to control in standard and intermediate risk, non-hospitalized adult SARS-CoV-2 infected participants and uninfected adult contacts of SARS-CoV-2 confirmed cases. The master protocol will outline the core elements of the study. Investigational products may be included in either or both study indications: early treatment and post-exposure prophylaxis (PEP). The study includes a phase 2 evaluation for all IPs. The platform trial design will allow for multiple IPs to be incorporated into the protocol as product specific appendices (PSA) as products are identified and become available. Each PSA will detail the interventions, the endpoints, target treatment effect, intended statistical analysis, the relevant control arms, and the sample size range. The PSA may define additional adaptive design elements, such as early declaration rules.
- Conditions
- SARS-CoV-2
- Being tested
- Upamostat, Placebo (PO)
- Keywords
- COVID-19, Early Treatment, Post-Exposure Prophylaxis, Outpatient
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpamostatDrug
Also called WX-671, RHB-107
Upamostat is available as a hydrogen sulphate salt (also designated as WX-671.1). WX-671.1 is a white to yellowish powder which is freely soluble in dimethyl sulfoxide and soluble in ethanol. The drug substance is very slightly soluble in water or 0.1 M HCl.
Placebo (PO)Drug
Oral Capsules
| Study group | Role | What they receive |
|---|---|---|
| Early Treatment: Upamostat 400 mg | Experimental | 400 mg (2 x 200 mg) capsules administered orally once daily for 14 days Receives: Drug: Upamostat |
| Early Treatment: Placebo Oral Capsule | Placebo comparator | The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. Receives: Drug: Placebo (PO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Sustained Alleviation or Resolution of COVID-19 Symptoms
Defined as the number of days from randomization within a PSA to the first day the participant reports all symptoms as mild or none for at least 3 consecutive days. Symptoms will be assessed via completion of a Screening Symptom Questionnaire at Enrollment and then a Daily Follow Up Symptom Questionnaire.
Measured: Day 0 to Day 28
Secondary outcomes (7)
Change in Overall COVID-19 Symptom Severity Score
Participants complete a Daily Symptom Follow Up Questionnaire on Days 1 through 28 and then at follow up visits. Symptoms are reported on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe). Symptoms assessed include nasal congestion, sore throat, hoarse voice, shortness of breath, cough, fatigue, myalgias, headache, chills, fever, nausea or vomiting, change in taste and change in smell. An additional question assesses overall symptom severity on the same 4 point scale
Measured: Day 0 to Day 28
Time to Negative SARS-CoV-2 PCR
the time of the first of two consecutive readings below the lower limit of detection
Measured: Day 0 to Week 12
Development of New Severe COVID-19 Symptoms
Proportion of participants in each treatment group developing new COVID-19 symptoms on the Daily Symptom Questionnaire rated as severe from Day 0 to Day 28
Measured: Day 0 to Week 12
Return to Usual State of Health
Proportion of participants who report a return to usual state of health at Days 7, 14, 28, Week 8, and Week 12
Measured: Day 0 to Week 12
Return to Usual Activities
Proportion of participants who report a return to usual activities at Days 7, 14, 28, Week 8, and Week 12.
Measured: Day 0 to Week 12
All Cause Hospitalization
number of participants hospitalized for any reason
Measured: Day 0 to Week 12
All Cause Deaths
Number of all cause deaths
Measured: Day 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start29 Jan 2024
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An adaptive, randomized, double-blind, platform trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 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, RedHill Biopharma Limited, FHI Clinical, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954286
- Sponsor's protocol ID
- PC06
- Acronym
- PROTECT-APT 1
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2022
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Protocol for Early Treatment and Post-Exposure Prophylaxis of COVID-19 Adaptive Platform Trial PROTECT-APT 1
- ClinicalTrials.gov ID
- NCT05954286
- Acronym / sponsor ID
- PROTECT-APT 1 / PC06
- Conditions
- SARS-CoV-2
- Keywords
- COVID-19, Early Treatment, Post-Exposure Prophylaxis, Outpatient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 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, RedHill Biopharma Limited, FHI Clinical, Inc.
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an adaptive, randomized, double blind, platform trial evaluating promising investigational products (IP) for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Detailed description
This multicenter trial will be conducted in both domestic and international sites. The study will compare IPs to control in standard and intermediate risk, non-hospitalized adult SARS-CoV-2 infected participants and uninfected adult contacts of SARS-CoV-2 confirmed cases. The master protocol will outline the core elements of the study. Investigational products may be included in either or both study indications: early treatment and post-exposure prophylaxis (PEP). The study includes a phase 2 evaluation for all IPs. The platform trial design will allow for multiple IPs to be incorporated into the protocol as product specific appendices (PSA) as products are identified and become available. Each PSA will detail the interventions, the endpoints, target treatment effect, intended statistical analysis, the relevant control arms, and the sample size range. The PSA may define additional adaptive design elements, such as early declaration rules.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- An adaptive, randomized, double-blind, platform trial
| Arm | Type | Receives |
|---|---|---|
| Early Treatment: Upamostat 400 mg | Experimental | Drug: Upamostat400 mg (2 x 200 mg) capsules administered orally once daily for 14 days |
| Early Treatment: Placebo Oral Capsule | Placebo comparator | Drug: Placebo (PO)The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years
- Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment
- Presence of two or more Screening Symptoms listed in Supplement 3 with at least two symptoms classified as moderate to severe (and/or ≥ 2 on the frequency questions or loss of taste/smell questions) at the time of enrollment a. For participants who have preexisting conditions causing mild or moderate symptoms listed on the Screening Symptom Questionnaire, there must be an increase of at least one severity level for that symptom at enrollment (For example, prior to illness participant routinely experienced headaches rated as moderate severity, now rating headache as severe at enrollment)
- Symptom onset ≤ 5 days prior to enrollment
- Age ≥ 18 years
Key exclusion criteria (31 listed)
- 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
- Laboratory confirmed SARS-CoV-2 infection 6 to 90 days prior to enrollment
- Oxygen saturation < 92% on room air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpamostatAlso: WX-671, RHB-107Upamostat is available as a hydrogen sulphate salt (also designated as WX-671.1). WX-671.1 is a white to yellowish powder which is freely soluble in dimethyl sulfoxide and soluble in ethanol. The drug substance is very slightly soluble in water or 0.1 M HCl. | Drug | Early Treatment: Upamostat 400 mg |
| Placebo (PO)Oral Capsules | Drug | Early Treatment: Placebo Oral Capsule |
Primary outcome
Time to Sustained Alleviation or Resolution of COVID-19 Symptoms
Time frame: Day 0 to Day 28
Defined as the number of days from randomization within a PSA to the first day the participant reports all symptoms as mild or none for at least 3 consecutive days. Symptoms will be assessed via completion of a Screening Symptom Questionnaire at Enrollment and then a Daily Follow Up Symptom Questionnaire.
7 secondary outcomes
Change in Overall COVID-19 Symptom Severity Score
Time frame: Day 0 to Day 28
Time to Negative SARS-CoV-2 PCR
Time frame: Day 0 to Week 12
Development of New Severe COVID-19 Symptoms
Time frame: Day 0 to Week 12
Return to Usual State of Health
Time frame: Day 0 to Week 12
Return to Usual Activities
Time frame: Day 0 to Week 12
All Cause Hospitalization
Time frame: Day 0 to Week 12
All Cause Deaths
Time frame: Day 0 to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Upamostat in people with SARS-CoV-2, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 6 sites in 4 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 14 inclusion and 31 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, South Africa, Thailand, Uganda. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 to Sustained Alleviation or Resolution of COVID-19 Symptoms (time frame: Day 0 to Day 28). 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 17 Apr 2026.