Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2

Exclusion Criteria

• •Women who are pregnant, breast feeding or of child bearing potential and not using contraception
• •Absence of a qualifying type of cancer as defined by standard ICD-10 diagnostic criteria
• •Treatment initiated \>12 months prior to baseline or were not on active therapy ≤12 months prior to enrollment with FDA approved oral, intramuscular and/or intravenous chemotherapy, immunotherapy, targeted therapy, other therapy or any combination of these agents
• •Patient receiving only radiation therapy
• •Patient with an ECOG performance status of 2 or higher
• •Patient with an expected cancer survival of less than 12 months by disease category
• •Patient receiving adjuvant endocrine therapy as their only form of therapy for early-stage breast cancer
• •Solid tumor patients more than 6 months post treatment and their cancer is considered to be stable or in remission as determined by the Investigator
• •AZD7442 IM administration at any time prior to day of enrollment
• •AZD7442 IM or IV administration on the same day as the patient receives any IV or IM cancer treatment
• •Have a positive test for SARS-CoV-2 antigen performed by either Rapid Test or SARS-CoV-2 RNA by RT-PCR (Polymerase Chain Reaction) less than 90 days prior to enrollment
• •Patient with a prior (within 90 days), current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any other EUA approved SARS-CoV-2 treatment
• •Patient with fever \>100.0 F, and/or cough, chills, loss of smell or taste or shortness of breath or any other signs or symptoms consistent with COVID-19 within 5 days prior to enrollment
• •Patient who has any known active acute respiratory infection
• •Patient who has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
• •Patient who has a past SARS-CoV-2 infection within 90 days prior to randomization
• •Patient who has received vaccination with any dose of Janssen, Pfizer or Moderna COVID-19 vaccine less than 14 days prior to baseline for this study
• •Planned use of any investigational, authorized, or approved vaccine for COVID-19 less than 14 days prior to administration of AZD7442 600 mg IM or IV
• •Patient who is unwilling to have SARS-CoV-2 RBD-IgG antibody levels drawn at least 3 times
• •Patient who is unwilling to receive treatment with IM or IV AZD7442
• •Patient who is unwilling to complete baseline and up to 13 follow-up Experience/Clinical Outcome Assessment (COA) surveys.
• •Patient who is unwilling to complete baseline and up to 5 QoL assessments
• •Patient who is unwilling to have blood drawn for AZD7442 serum concentration at least 9 times
• •Patient who is unwilling to have blood drawn at least once for T-cell assay
• •Patient whose native language is not English and does not have a person who can translate the regulatory documents, surveys and QoL assessments.
• •Patient who is unable to provide Informed Consent or Authorization for Release of Health Information due to mental illness that requires a Legally Authorized Representative.
• •Patient who is legally blind and does not have a witness/caregiver who has agreed to assist the patient in his/her participation in the study.
• •Patient with a history of a severe allergic reaction (i.e., anaphylaxis) to any of the components of AZD7442
• •Patient with a history of severe allergic reaction (hypersensitivity) to any SARS-COV-2 vaccination, Polyethylene Glycol (PEG) or Polysorbate 80
• •Patient who is illiterate and does not have a witness/caregiver who has agreed to assist the patient in his/her participation in the study.
• •Patient who is participating in an interventional trial for prophylaxis or treatment of SARS-CoV-2