Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2
Status:
Recruiting
Trial end date:
2023-12-03
Target enrollment:
Participant gender:
Summary
If a treated cancer patient cannot make antibodies to a Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2) Emergency Use Authorization (EUA) or approved vaccine, their risk
for infection and its sequelae are significantly increased. The Astra-Zeneca
Immuno-Suppressed Program (AISP) is designed to address whether a patient treated for cancer
who receives a single-dose of Evusheld (AZD7442) 600 mg IM or IV will maintain a
stable/protective effect against symptomatic SARS-CoV-2 infection including SARS-CoV-2
related hospitalization and/or SARS-CoV-2 related death up to 12 months post-baseline. The
program will focus on patients with cancer who have been treated with chemotherapy,
immunotherapy, targeted therapy, other therapy or combination therapy with or without
radiation therapy within 12 months prior to enrollment, are willing/able to receive one IM or
IV injection of Evusheld, are able to complete 14 Patient Experience/Clinical Outcome
Assessment (COA) surveys, 6 Quality of Life (QoL) assessments and are willing to allow serum
concentrations of Evusheld to be drawn 9 times, 3 SARS-CoV-2 Receptor Binding
Domain-Immunoglobulin G (RBD-IgG) tests, and T-cell assay to be drawn once. In the event of a
symptomatic break-thru SARS-CoV-2 positive infection by SARS-COV-2 Ribonucleic Acid (RNA) by
Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, the patient will have an
additional Evusheld serum concentration, SARS-CoV-2 RBD-IgG antibody level and T-cell assay
obtained in a temporally related manner. The program requires treatment with Evusheld 600 mg
IM or IV.