NCT05438498

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

Terminated Phase 3 Last updated 8 September 2023

What this trial tests

Phase 3 trial testing Evusheld (tixagevimab+cilgavimab) IM or IV in SARS-CoV-2 Infection in 550 participants. Terminated before completion.

Timeline

3 June 2022

Primary endpoint
29 April 2023

30 June 2023

Quick facts

Lead sponsor	MediMergent, LLC
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	550
Start date	3 June 2022
Primary completion	29 April 2023
Estimated completion	30 June 2023
Sites	40 locations across United States

Drugs / interventions tested

• Evusheld (tixagevimab+cilgavimab) IM or IV — full drug profile →

Conditions studied

• SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →

Sponsor

MediMergent, LLC — full company profile →

Who can join

Adults 18 to 100, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Critical Analysis of the Use of Cilgavimab plus Tixagevimab Monoclonal Antibody Cocktail (Evusheld™) for COVID-19 Prophylaxis and Treatment.
   Focosi D, Casadevall A. · · 2022 · cited 52× · PMID 36146805 · DOI 10.3390/v14091999
2. Tixagevimab/Cilgavimab in SARS-CoV-2 Prophylaxis and Therapy: A Comprehensive Review of Clinical Experience.
   Akinosoglou K, Rigopoulos EA, Kaiafa G, Daios S, et al · · 2022 · cited 23× · PMID 36680160 · DOI 10.3390/v15010118
3. Cancer management during the COVID-19 world pandemic.
   Sobhani N, Mondani G, Roviello G, Catalano M, et al · · 2023 · cited 6× · PMID 37642709 · DOI 10.1007/s00262-023-03524-1