PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19

Completed · Phase 2 · Has a placebo group

Conditions studied: SARS-CoV-2

In brief

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).

Key facts

Study ID

NCT05954286

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

92

Starts

2024-01-29

Expected to finish

2025-04-24

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Presence of any of the following comorbidities that per the PI puts the patient at high risk of developing severe COVID-19 illness:
• a. 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
• Inclusion Criteria:
• Age ≥ 18 years
• Asymptomatic contact of an individual with laboratory confirmed SARS-CoV-2 infection defined as:
• a. 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
• Exclusion Criteria:
• 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:
• Inclusion Criteria:
• Must also meet the intervention specific inclusion/exclusion criteria for at least one PSA that is enrolling participants
• Exclusion Criteria:
• Absence of informed consent
• Pregnancy

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• KUR Research — Nashville, Tennessee, United States
• Josha Research — Bloemfontein, South Africa
• Royal Thai Army Clinical Research Center (RTA CRC) Royal Thai Army-Armed Forces Research Institute of Medical Sciences (RTA-AFRIMS) — Bangkok, Thailand
• Makerere University Walter Reed Project — Fort Portal, Uganda

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.