Long-term Impact in Intensive Care Survivors of Coronavirus Disease (COVID-19)

NCT ID: NCT05175339

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-29

Study Completion Date

2023-11-13

Brief Summary

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The Investigator seeks to evaluate the long term neurological and pulmonary sequelae of COVID-19.

Detailed Description

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Recent data suggests that survivors of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or (COVID-19) report adverse health status, including neurological and cognitive deficits and impaired pulmonary function, even months after discharge. Adult COVID-19 survivors after ICU stay, who are noted to have increased mortality and organ failure, are at higher risk of long-term disabilities and impaired quality of life. This study is one branch of a multi-site study coordinated by Gilead Sciences, in which participants who were critically ill with COVID-19 will be followed at three and nine months after discharge to test pulmonary function, cognitive function, and quality of life.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Clinically suspected or laboratory confirmed COVID-19 infection by real-time PCR
* Admission to an intensive care unit for COVID-19 and discharge

Exclusion Criteria

* Pregnancy
* Participants unable to complete long-term follow-up due to logistical problems
* Participant paralyzed before being admitted to hospital for COVID-19
* History of pulmonary resection
* Previous pulmonary transplant
* Documented advanced neurologic order for which the patient is unable to carry out 6 minute walk test
* Documented psychiatric disease for which the patient is unable to carry out interview
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jannelle Molina

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

University of Texas Health Science Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00276578

Identifier Type: -

Identifier Source: org_study_id

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