Convalescent Plasma for COVID-19 Close Contacts

Inclusion Criteria:

Group B: SARS-CoV-2 PCR positive but asymptomatic or mild symptoms at screening

- Subjects must be 18 years of age or older

- Close contact* of a person with COVID-19 within the last 7 days. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts.

- Evidence of infection by nasopharyngeal swab PCR that is positive for SARS-CoV-2

- No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms+ may include:

- Mild rhinorrhea

- Mild sore throat or throat irritation

- Mild nonproductive cough

- Mild fatigue (able to perform Activities of Daily Living (ADLs))

- High risk for severe COVID-19 based on a risk score of ≥ 2 Calculated Risk Score of ≥ 2 points, with risk factors based on Center for Disease Control and Prevention (CDC) description

- Age 65-74: 1 point

- Age ≥ 75: 2 points

- Known cardiovascular disease (including hypertension): 1 point

- Diabetes mellitus: 1 point

- Pulmonary disease (COPD, moderate to severe asthma, current smoking or other): 1 point

- Morbid obesity: 1 point

- Immunocompromised state: 1 point Received a bone marrow or solid organ transplant at any time, received chemotherapy for a malignancy within the past 6 months, has an acquired or congenital immunodeficiency, currently receiving immunosuppressive or immune modulating medications, HIV with non-suppressed viral load and/or cluster of differentiation 4 (CD4+) T cell count <200 cells/mL).

- Mild symptoms are rated by participant as mild and not interfering with normal daily activities

Group C: SARS-CoV-2 PCR negative (uninfected) at time of screening but asymptomatic or mildly symptomatic at screening

- Subjects must be 18 years of age or older

- Close contact* of a person with COVID-19 within the last 7 days. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts.

- Nasopharyngeal swab negative for SARS-Cov-2 at screening

- No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms+ may include:

- Mild rhinorrhea

- Mild sore throat or throat irritation

- Mild nonproductive cough

- Mild fatigue (able to perform ADLs)

- High risk for severe COVID-19 based on a risk score of ≥ 2, as above.*

- Close contact is defined by CDC as being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time (without PPE); close contact can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 case.

- Mild symptoms are rated by participant as mild and not interfering with normal daily activities

Exclusion Criteria:

Group B: SARS-CoV-2 PCR positive but asymptomatic or mild symptoms at screening

- Receipt of any blood product in past 120 days.

- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.

- Confirmed or self-reported presumed COVID-19 at least one week before index case first became ill with COVID-19.

- Symptoms consistent with COVID--‐19 infection that are more than mild (as defined above) at time of screening. Subjects who report fever (Tmax > 100.4 F) are not eligible for enrollment.

- Symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medical unstable on the day of planned enrollment.

- History of allergic reaction to transfusion blood products

- Inability to complete infusion of the product within 48 hours after randomization.

- Pregnancy (or planning for pregnancy in next three months) or breastfeeding.

- Resident of a long term or skilled nursing facility

- Known prior diagnosis of immunoglobulin A (IgA) deficiency

- Oxygen saturation that is < 95% at the screening visit

- Participation in another clinical trial of anti-viral agent(s) for COVID-19

Group C: SARS-CoV-2 PCR negative (uninfected) at time of screening

- Receipt any blood product in past 120 days.

- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principle investigator, would affect subject safety and/or compliance.

- Confirmed or self-reported presumed COVID-19 at least one week before index case first became ill with COVID-19.

- Symptoms consistent with severe COVID-19 infection that are more than mild (as defined above) at time of screening. Subjects who report fever (Tmax > 100.4 F) are not eligible for enrollment.

- Symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medically unstable on the day of planned enrollment.

- Laboratory evidence of SARs-CoV-2 infection (i.e. RT-PCR) at time of screening

- History of allergic reaction to blood products

- Inability to complete infusion of the product within 48 hours after randomization.

- Pregnancy (or planning for pregnancy in next three months) or breastfeeding.

- Resident of a long term or skilled nursing facility

- Known history of immunoglobulin A (IgA) deficiency

- Oxygen saturation that is < 95% at the screening visit

- Participation in another clinical trial of anti-viral agent(s) for COVID-19