PREP (Pre-Exposure Prophylaxis) of COVID-19

COVID-19 Clinical Trial

— PrEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05461378
• Other study ID #: PrEP C-19
• Status: Active, not recruiting
• Start date: July 26, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Est. completion date: March 1, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Immuno-Deficiency
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Evusheld
Participants who have received or plan to receive Evusheld.

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Ghady Haidar	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	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.	12-months
Secondary	Concentration of AZD7442 in serum	Collected at 1, 3, AND 9 months	12-months
Secondary	Assessment of SARS-CoV-2 Spike IgG levels using Bioplex/Biorad assays, viral neutralization assay using competitive ACE2 EIA, and pseudovirus neutralization titers	Collected at enrollment and 1, 3, 6, 9, and 12 months	12-months
Secondary	Assessment of T-cell responses using an ELISPOT assay	Obtained before and after vaccination	12-months
Secondary	Determining SARS_CoV-2 variant type using whole genome sequencing	Collected among subjects with breakthrough infection	12-months
Secondary	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	Collected during breakthrough infection	12-months
Secondary	Proportion of participants with =1 COVID-19-related medically-attended visit	Participants with =1 COVID-19-related medically-attended visit	12-months
Secondary	Proportion of participants who die by the end of the study	COVID-19 associated and all-cause mortality	12-months
Secondary	Lifestyle Modification Questionnaire	Proportion of participants who report changes in lifestyle	12-months