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).
• 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
• 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
• 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.