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

Inclusion Criteria:

• Male or Female gender at birth
• Age at least 18 years
• Women who are not pregnant, not breast feeding and of child bearing potential usingcontraception prior to enrollment in the study. Women of child bearing potential mustagree to continued use of contraception throughout the 12 months of studyparticipation.
• It is preferable that a patient has access to a "smartphone" or tablet or laptop ordesktop computer and/or an email address
• In the event that a patient does not have access to any of the above, the patient maycomplete all follow-up surveys via the study's Call Center or in written form in theoffices of the Principal Investigator as specified in the protocol
• Documented diagnosis of either hematologic malignancy or solid tumor as identified bystandard ICD-10 diagnostic category
• Patients may be included with any ONE of the following criteria:
• On active treatment for solid tumor or hematologic malignancies. This can include:high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day whenadministered for ≥2 weeks), as well as any FDA-approved alkylating agents,antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeuticagents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, andother biologic agents that are immunosuppressive or immunomodulatory (e.g., B-celldepleting agents) or any combination of these agents
• Hematologic malignancy patients can also be included if he/she is up to 12 monthspost-treatment and either in remission, stable or progressing as determined by theInvestigator
• Solid tumor patients can also be included if he/she is up to 6 months post-treatment
• Received chimeric antigen receptor (CAR-T) or hematopoietic stem cell transplant (within 1 year of transplantation or taking immunosuppression therapy)
• Cancer is progressing as determined by the Investigator
• Treatment must have been initiated ≤12 months prior to baseline for all patients,
• Concomitant radiation therapy is permitted but cannot be the sole therapy
• Have been vaccinated with one or more doses of Janssen, Moderna or Pfizer COVID-19vaccine
• If having been previously diagnosed with SARS-CoV-2 infection, the diagnosis has to beat least 90 days prior to study randomization. If previously diagnosed, previoustreatment with Ivermectin or hydroxychloroquine is acceptable.
• Have a negative SARS-CoV-2 antigen rapid test performed in the office at screening
• Patient willing to receive treatment with AZD7442 600 mg IM or IV
• Patient willing to complete baseline and 13 post-enrollment PatientExperience/Clinical Outcome Assessment surveys.
• Patient willing to complete baseline and 5 QoL assessments
• Patient willing to have blood drawn for serum concentration of AZD7442 9 timespost-baseline and repeated if patient becomes COVID-19 positive
• Patient willing to have blood drawn for T-cell assay at day 30 post-baseline andrepeated if patient becomes SARS-COV-2 RNA by RT-PCR positive
• Patient willing to have RBD-IgG drawn at baseline, days 90 and 180 post-baseline andrepeated if patient becomes SARS-COV-2 RNA by RT-PCR positive
• Patient willing to signed Informed Consent Form
• Patient willing to sign Authorization for Release of Health Information (includingtreating physicians' or other medical personnel's records, medication prescriberrecords, pharmacy records and medical insurance claims)

Exclusion Criteria:

• Women who are pregnant, breast feeding or of child bearing potential and not usingcontraception
• Absence of a qualifying type of cancer as defined by standard ICD-10 diagnosticcriteria
• Treatment initiated >12 months prior to baseline or were not on active therapy ≤12months prior to enrollment with FDA approved oral, intramuscular and/or intravenouschemotherapy, immunotherapy, targeted therapy, other therapy or any combination ofthese 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 forearly-stage breast cancer
• Solid tumor patients more than 6 months post treatment and their cancer is consideredto 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 IMcancer treatment
• Have a positive test for SARS-CoV-2 antigen performed by either Rapid Test orSARS-CoV-2 RNA by RT-PCR (Polymerase Chain Reaction) less than 90 days prior toenrollment
• Patient with a prior (within 90 days), current, or planned use of any of COVID-19convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any other EUAapproved SARS-CoV-2 treatment
• Patient with fever >100.0 F, and/or cough, chills, loss of smell or taste or shortnessof breath or any other signs or symptoms consistent with COVID-19 within 5 days priorto enrollment
• Patient who has any known active acute respiratory infection
• Patient who has persistent (refractory to treatment for ≥14 days) bacterial or fungalinfection
• 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 ModernaCOVID-19 vaccine less than 14 days prior to baseline for this study
• Planned use of any investigational, authorized, or approved vaccine for COVID-19 lessthan 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 3times
• Patient who is unwilling to receive treatment with IM or IV AZD7442
• Patient who is unwilling to complete baseline and up to 13 follow-upExperience/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 cantranslate the regulatory documents, surveys and QoL assessments.
• Patient who is unable to provide Informed Consent or Authorization for Release ofHealth Information due to mental illness that requires a Legally AuthorizedRepresentative.
• Patient who is legally blind and does not have a witness/caregiver who has agreed toassist the patient in his/her participation in the study.
• Patient with a history of a severe allergic reaction (i.e., anaphylaxis) to any of thecomponents of AZD7442
• Patient with a history of severe allergic reaction (hypersensitivity) to anySARS-COV-2 vaccination, Polyethylene Glycol (PEG) or Polysorbate 80
• Patient who is illiterate and does not have a witness/caregiver who has agreed toassist the patient in his/her participation in the study.
• Patient who is participating in an interventional trial for prophylaxis or treatmentof SARS-CoV-2