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

Stopped early · Phase 3

Conditions studied: SARS-CoV-2 Infection

In brief

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.

Key facts

Study ID

NCT05438498

Run by

MediMergent, LLC

People needed

550

Starts

2022-06-03

Expected to finish

2023-06-30

Last updated by the study team

2023-09-08

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female gender at birth
• Age at least 18 years
• Women who are not pregnant, not breast feeding and of child bearing potential using contraception prior to enrollment in the study. Women of child bearing potential must agree to continued use of contraception throughout the 12 months of study participation.
• It is preferable that a patient has access to a "smartphone" or tablet or laptop or desktop computer and/or an email address
• In the event that a patient does not have access to any of the above, the patient may complete all follow-up surveys via the study's Call Center or in written form in the offices of the Principal Investigator as specified in the protocol
• Documented diagnosis of either hematologic malignancy or solid tumor as identified by standard 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 when administered for ≥2 weeks), as well as any FDA-approved alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents) or any combination of these agents
• Hematologic malignancy patients can also be included if he/she is up to 12 months post-treatment and either in remission, stable or progressing as determined by the Investigator
• 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-19 vaccine
• If having been previously diagnosed with SARS-CoV-2 infection, the diagnosis has to be at least 90 days prior to study randomization. If previously diagnosed, previous treatment 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 Patient Experience/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 times post-baseline and repeated if patient becomes COVID-19 positive
• Patient willing to have blood drawn for T-cell assay at day 30 post-baseline and repeated 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 and repeated 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 (including treating physicians' or other medical personnel's records, medication prescriber records, pharmacy records and medical insurance claims)

You may not qualify if…

• 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.

Where it is running

• Compassionate Cancer Care Medical Group — Corona, California, United States
• Compassionate Care Medical Group — Fountain Valley, California, United States
• Ventura County Hematology Oncology — Oxnard, California, United States
• Compassionate Cancer Care Medical Group — Riverside, California, United States
• Cancer Center of Southern California — Santa Monica, California, United States
• Eastern Connecticut Hematology and Oncology — Norwich, Connecticut, United States
• South Florida Cancer Care — Margate, Florida, United States
• Florida Cancer Affiliates-Ocala — Ocala, Florida, United States
• Mid-Florida Hematology Oncology Center — Orange City, Florida, United States
• Comprehensive Hematology Oncology — St. Petersburg, Florida, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Mary Bird Perkins — Baton Rouge, Louisiana, United States
• Maryland Oncology Hematology — Annapolis, Maryland, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Maryland Oncology Hematology — Bethesda, Maryland, United States
• Maryland Oncology Hematology — Brandywine, Maryland, United States
• Maryland Oncology Hematology — Columbia, Maryland, United States
• Maryland Oncology Hematology — Lanham, Maryland, United States
• Maryland Oncology Hematology — Rockville, Maryland, United States
• Maryland Oncology Hematology — Silver Spring, Maryland, United States
• Health Partners Institute-MMORC — Saint Louis Park, Minnesota, United States
• Oncology Hematology Associates — Springfield, Missouri, United States
• New Jersey Center for Cancer Research — Brick, New Jersey, United States
• Hunterdon Regional Cancer Center — Flemington, New Jersey, United States
• Minniti Center for Oncology and Hematology — Mickleton, New Jersey, United States

Full record on ClinicalTrials.gov

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