Skip to main content
OpenTrials
Completed

NCT Number: NCT05461378

PREP (Pre-Exposure Prophylaxis) of COVID-19

This is a study of immunocompromised individuals who have received or plan to receive a drug called EVUSHELD. This study is looking at any serious adverse events that might happen after receiving EVUSHELD, the levels of EVUSHELD in participant's blood, blood antibody levels, neutralizing antibodies against SARS-CoV-2 (the virus that causes COVID-19), and other blood responses related to the immune system and COVID-19. Investigators are collecting blood and may also collect other samples such as nose swabs, oral swabs, or saliva.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immuno-Deficiency COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

This is a prospective study of 500 immunocompromised participants at UPMC health system. EVUSHELD will be given according to the EUA in the United States as a part of standard of care by the patient's health care provider. Patients who receive intramuscular EVUSHELD as standard of care will be enrolled and followed for 12-months. The target sample size is 500 immunocompromised individuals; serum concentrations of AZD7442 will be obtained in all patients at the 6 (or at enrollment if the time point has passed) and 12 month timepoints.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 12 and at least 40 kg
  • Eligible for EVUSHELD as per the EUA

Exclusion criteria

  • Active and confirmed COVID-19
  • Known or suspected pregnancy, concurrent lactation
  • Any other significant disease, disorder, or finding, in the opinion of the investigator, that may significantly increase the risk to the participant because of participation in the study, affect the ability of the subject to participate in the study, or impair interpretation of the study data

Treatment and study plan

EVUSHELD

Drug

Participants who have received or plan to receive Evusheld.

Primary outcomes

  1. Concentration of AZD7442 in serum over time [ENROLLMENT, 6 MONTHS, 12 MONTHS] Concentration of AZD7442 in serum over time [ENROLLMENT, 6 MONTHS, 12 MONTHS] Concentration of AZD7442 in serum over time [ENROLLMENT, 6 MONTHS, 12 MONTHS]

    Time frame: 12-months

    The primary objective of PrEP C-19 is to measure AZD7442 serum concentration levels by blood draws at 6 months (or at enrollment if the time point has passed) and 12 months after IM administration of EVUSHELD.

Secondary outcomes

  1. Concentration of AZD7442 in serum

    Time frame: 12-months

    Collected at 1, 3, AND 9 months

  2. Assessment of SARS-CoV-2 Spike IgG levels using Bioplex/Biorad assays, viral neutralization assay using competitive ACE2 EIA, and pseudovirus neutralization titers

    Time frame: 12-months

    Collected at enrollment and 1, 3, 6, 9, and 12 months

  3. Assessment of T-cell responses using an ELISPOT assay

    Time frame: 12-months

    Obtained before and after vaccination

  4. Determining SARS_CoV-2 variant type using whole genome sequencing

    Time frame: 12-months

    Collected among subjects with breakthrough infection

  5. Determining Concentration of AZD7442 in serum, SARS-CoV-2 Spike IgG levels using Bioplex/Biorad assays, viral neutralization assay using competitive ACE2 EIA, and pseudovirus neutralization titers

    Time frame: 12-months

    Collected during breakthrough infection

  6. Proportion of participants with ≥1 COVID-19-related medically-attended visit

    Time frame: 12-months

    Participants with ≥1 COVID-19-related medically-attended visit

  7. Proportion of participants who die by the end of the study

    Time frame: 12-months

    COVID-19 associated and all-cause mortality

  8. Lifestyle Modification Questionnaire

    Time frame: 12-months

    Proportion of participants who report changes in lifestyle

Sponsors and collaborators

Lead sponsor

Ghady Haidar

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Prospective Observational Cohort Study of Pre-Exposure Prophylaxis of COVID-19 in Immunocompromised Patients Receiving the Monoclonal Antibody AZD7442 (EVUSHELD)

Acronym: PrEP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2022
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.