Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-07-17

Brief Summary

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Sotrovimab binds to a conserved epitope on the severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 spike protein outside the receptor-binding motif and has been shown to reduce the risk of hospitalization and/or death when administered as early treatment in non-hospitalized patients that are at risk for progression to severe disease. Immunocompromised (IC) patients are prioritized to receive early treatment for COVID-19 as they are at high risk of disease progression, and because of their potential for prolonged viral shedding and the resulting increased risk of emergent viral mutations and potential onward community transmission.

This genomic surveillance study will aim to describe changes in the SARS-CoV-2 spike protein observed in IC participants receiving sotrovimab as standard of clinical care in sentinel sites at a national level to assess potential emergence of viral variants.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study is a prospective cohort study which will enroll IC non-hospitalized participants receiving sotrovimab treatment as per standard of clinical care for COVID-19 in sentinel sites.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants receiving Sotrovimab

Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites

Group Type EXPERIMENTAL

Sotrovimab

Intervention Type DRUG

Sotrovimab dose and administration per standard of clinical care

Interventions

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Sotrovimab

Sotrovimab dose and administration per standard of clinical care

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must be adult and of greater than or equal to (\>=) 18 years of age or older at the time of consent
* Participants must be immunocompromised (IC) population eligible to receive sotrovimab
* A positive polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 through clinical testing or routine screening undertaken as part of clinical management
* Prescribed treatment with sotrovimab as standard of clinical care
* Able to provide informed consent and willing to adhere to study-related procedures

Exclusion Criteria

* Participants who require hospitalization (related or not to COVID-19) at baseline
* Participants who initiated sotrovimab therapy in inpatient settings
* Participants unable to perform nasal/oropharyngeal sample collection
* Blinded participants from other COVID-19 related trials

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No