Prophylaxis and Treatment of COVID-19 (PROTECT-APT)

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

Inclusion Criteria:

1. Population A: Symptomatic SARS-CoV-2 or ILI Cases (hospitalized and non- hospitalized)

   1. Age ≥ 18 years old

   2. Presence of one or more of the following symptoms at enrollment:

      • 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
   3. Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment
   4. Symptom onset ≤ 5 days prior to enrollment

   OR

   1. Age ≥ 18 years old
   2. 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

2. Population B: SARS-CoV-2 or ILI Contacts

   1. Age ≥ 18 years old

   2. 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
   3. For SARS-CoV-2 contacts: Negative screening SARS-CoV-2 molecular or antigen diagnostic test performed at screening or within ≤ 24 hours of enrollment
   4. Exposure and enrollment within 6 days or less from when the symptomatic, confirmed SARS-CoV-2 or ILI case first had symptoms

Exclusion Criteria:

1. Population A: Adults seeking care or testing for SARS-CoV-2 or ILI

   a. Laboratory confirmed SARS-CoV-2 infection 6 to 90 days prior to enrollment

2. Population B: Adult contacts of SARS-CoV-2 or ILI infected individuals

   1. Symptoms attributed to COVID-19 or ILI as assessed by a medical provider
   2. Positive molecular or antigen 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

      • 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
   4. 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

   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.
      • Hospitalization for isolation or quarantine requirements or for social reasons will NOT constitute an exclusion criterion

For Both populations:

1. Absence of informed consent
2. Individuals who the study investigators believe are unable to comply with the requirements of the study