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

Description

The primary objective is to quantify the serum concentration of Evusheld (AZD7442) at 1, 2, 3, 4, 5, 6, 7, 9 or 12-months post-baseline in all qualified cancer patients treated with a single-dose of Evusheld 600 mg IM or IV at baseline.

The secondary objectives of the study are as follows:

• Compare the incidence of symptomatic Sudden Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death between solid tumor and hematologic malignancy patients.
• Compare of the incidence of symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only over 12 months post-baseline.
• Compare the serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline between solid tumor and hematologic malignancy patients.
• Compare the serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only.
• Compare of the incidence of symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death to the levels of serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline in all patients.
• Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia and World Health Organization (WHO) score of ≥5) based on the TACKLE study definition between solid tumor and hematologic malignancy patients.
• Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia, and WHO score of ≥5) based on the TACKLE study definition death between patients treated with chemotherapy only, immunotherapy only, targeted therapy only or other/combination therapy only over 12 months post-baseline.
• Compare the incidence of severe SARS-CoV-2 (pneumonia or hypoxemia, and WHO score of ≥5) based on the TACKLE study definition to the levels of serum concentration of Evusheld at 1, 2, 3, 4, 5, 6, 7, 9 and 12-months post-baseline in all patients.
• Compare time to first event e.g., SARS-COV-2 RNA by Reverse Transcription Polymerase Chain Reaction (RT-PCR) positivity, symptomatic SARS-CoV-2 infection, hospitalization, and/or death between all four strata
• Compare Quality-of-Life metrics in all cancer patients, as measured by change from baseline to days 2, 90, 180, 270, and 360 post-baseline, and then compare the same Quality-of-Life metrics at each timepoint between each of the four strata
• Assess patient safety and adverse events including medically attended visits, Emergency Room/Urgent Care/Telehealth visits using Patient Experience/Clinical Outcome Assessment (COA) survey data for patients in each of the four strata
• Evaluate whether solid tumor or hematologic malignancy patients have a greater incidence of Evusheld-related side effects
• Assess the use of Machine Learning to predict the incidence of SARS-CoV-2 infection at days 30, 60, 90, 120, 150, 180, 210, 270 and 360 post-baseline in all cancer patients based on serum Evusheld concentration levels 3.3.3 Exploratory Objectives:
• Virologic surveillance to detect all SARS-CoV-2 variants occurring during the study in patients that test positive for SARS-CoV-2 by SARS-COV-2 RNA by Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing
• Detection of potential new variants identified by positive SARS-COV-2 RNA by RT-PCR testing

Details