Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons

Completed

• Conditions: Acute and Long Term Effects of COVID-19 on Cardiac Function; Acute and Long Term Effects of COVID-19 on Systemic Inflammation; Acute and Long Term Effects of COVID-19 on Lung Function; Acute and Long Term Effects of COVID-19 on Kidney Function; Acute and Long Term Effects of COVID-19 on Brain Function

• Registration Number: NCT04401449
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

Background:

COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it.

Objective:

To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection.

Eligibility:

People ages 18-80 with COVID-19 infection

Design:

Participants will be screened with a review of their medical records.

Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests.

Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein.

Participants will have an ultrasound of the kidneys and heart.

Participants will provide blood and urine samples. They will provide nasal swabs.

Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction.

Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid.

Participants will have lung and heart function tests.

At various points after recovery, participants will repeat many of these tests.

Detailed Description

Study Description: This protocol will enroll patients within a 50 mile radius of Bethesda, Maryland, to the Clinical Center in a longitudinal study using granular clinical observations including pulmonary and cardiac functional assessments, comprehensive immunologic evaluations, and innovative imaging. Sequential analysis of blood, bronchoalveolar lavage, and spinal fluid, with simultaneous serial imaging can provide insights into mechanisms associated with the initiation, progression and resolution of organ dysfunction and systemic inflammation due to COVID-19 infection.

Objectives:

Primary objective:

To link inflammatory responses present in blood, bronchoalveolar lavage, spinal fluid, and with imaging of COVID-19 target organs (lungs, heart and brain) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.

Secondary objectives

Assess the long-term effects of COVID-19 infection on immunologic, neurologic, cardiac and pulmonary function

Endpoints:

1. Measure inflammatory responses present in blood, bronchoalveolar lavage, and spinal fluid during the course of COVID-19 infection

2. Obtain imaging of target organs during the course of COVID-19 infection

3. Evaluate long-term effects of COVID-19 infection on immunologic, cardiac, pulmonary and neural function

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2025-01-22
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory responses of cells in lung and circulation	From onset of illness in hospital through acute phase ( days 1 28 more or less 7	Link inflammatory responses present in blood and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain ) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.

Trial Locations

Locations (2)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States