Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons
Condition: 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
MeSH terms: COVID-19; Inflammation; Disease Progression
Study type: Observational

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
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        men or women, 18 - 80 years of age, a) within 1- 28 days (+/- 7 days) of documented
        COVID-19 infection for acute care (n=150) with subsequent follow-up during recovery (28 +/-
        7 days to 12 weeks) and then during convalescence (Week 13 to 12 months - year 1), year 2
        convalesecent phase and year 3 convalesecent phase. Each Phase visit can be done out of
        window as per PI discretion. OR b) if care for acute COVID-19 infections was given at an
        outside site, participants would be evaluated during recovery (28 +/- 7 days to 12 weeks,
        during convalescence (Week 13 to 12 months - year 1), year 2 - convalesecent phase and year
        3 - convalesecent phase) Each Phase visit can be done out of window as per PI discretion.
      
Keywords: Immunological Function; SARSCoV-2; Neurologic Function; Cardiac Function; Pulmonary Function; Natural History