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

NCT05175339 | Completed

• 1 other identifier: IRB00276578
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (7)

• Change in pulmonary quality of life as assessed by St. George's Respiratory Questionnaire

  St. George's Respiratory Questionnaire measures quality of life associated with chronic respiratory diseases. It has been used in various reports of long-term impact of acute respiratory distress syndrome. Scores for each domain range from 0 to 100, with a lower score indicating better pulmonary-specific quality of life.

  3 months and 9 months post-discharge

• Change in pulmonary capacity as assessed with forced vital capacity

  Forced vital capacity will be measured with pulmonary function testing.

  3 months and 9 months post-discharge

• Change in pulmonary capacity as assessed with forced expiratory volume

  Forced expiratory volume will be measured with pulmonary function testing.

  3 months and 9 months post-discharge

• Change in pulmonary capacity as assessed with forced expiratory ratio

  Forced expiratory ratio will be measured with pulmonary function testing.

  3 months and 9 months post-discharge

• Change in cardiopulmonary and musculoskeletal strength as assessed by a six minute walk test

  Six Minute Walk Test provides an objective measure of cardiopulmonary and musculoskeletal function by recording distance (in meters) walked in six minutes.

  3 months and 9 months post-discharge

• Evaluation of residual pulmonary pathology as assessed by a chest x-ray

  Chest X-Ray will be used in the evaluation of residual pulmonary pathology.

  3 months post-discharge

• Evaluation of residual pulmonary pathology as assessed by a chest x-ray

  Chest X-Ray will be used in the evaluation of residual pulmonary pathology.

  9 months post-discharge

Secondary Outcomes (9)

• Change in cognitive function as assessed by the Montreal Cognitive Assessment (MoCA)

  3 months and 9 months post-discharge

• Change in cognitive function as assessed by BrainCheck

  3 months and 9 months post-discharge

• Change in depressive symptoms as determined by PHQ-9

  3 months and 9 months post-discharge

• Change in prevalence of anxiety symptoms as determined by GAD7

  3 months and 9 months post-discharge

• Change in quality of life as assessed by Fatigue Severity Scale

  3 months and 9 months post-discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population includes polymerase chain reaction (PCR) confirmed COVID-19 patients at Johns Hopkins Hospital and UT Houston Health Science Center who required intensive care unit admission for COVID-19 management.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Gilead Sciences: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jannelle Molina

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: September 29, 2021
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)