PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19 (NCT05954286) | Clinical Trial Compass
CompletedPhase 2
PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19
United States, South Africa, Thailand92 participantsStarted 2024-01-29
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Time to Sustained Alleviation or Resolution of COVID-19 Symptoms
Timeframe: Day 0 to Day 28
Trial details
NCT IDNCT05954286
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine