NCT04401449

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 202 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• 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 Cardiac Function
• Acute and Long Term Effects of COVID-19 on Kidney Function
• Acute and Long Term Effects of COVID-19 on Brain Function

Timeline

• Start date: 2020-05-21
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2020-05-26
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United States