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Studies to Determine Whether Oxygen Sensing is Impaired in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infected Patients

NCT04954157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-16

No results posted yet for this study

Summary

The two-part phases will each have a unique patient population, The goal in this application is to see if that carotid bodies are "offline" is correct and to determine whether a cohort of SARS-Cov-2 patients can be identified who fit this profile and would be suitable for drug treatment.

The testing will require one group of subjects to hold their breaths for a short period while the investigators monitor vital signs and blood O2 levels. A second group of "healthier" COVID subjects will be asked perform a walk-test inside their rooms for six minutes while vital signs are monitored as well as blood O2 levels. If the subjects are in the healthy control group, they will perform the walk test in a designated hallway at the medical center also while there vitals are being monitored. The goal, using a mild stimulus, is to determine whether respiration increases if blood O2 saturation is decreased. If it does not, that would indicate a failure of the carotid body oxygen sensing system.

Conditions

  • Hypoxia
  • SARS-CoV-2 Acute Respiratory Disease
  • Carotid Bodies

Interventions

DIAGNOSTIC_TEST

Phase-1: Breath Holding Test

In this phase of the study, each subject will be asked to hold their breath for up to 60 seconds or until they can longer hold it. While they are holding their breath, subjects will be hooked up to a monitor that will measure their Peripheral oxygen saturation (SpO2) respiratory rate (RR), and heart rate (HR).

DIAGNOSTIC_TEST

Phase 2: 6-Minute Walk Test (6MWT)

In this phase of the study, each subject will be asked to walk for 6 minutes in their hospital room or hallway. Their rate of perceived exertion will be measured while also hooked up to a monitor that will measure their Peripheral oxygen saturation (SpO2) respiratory rate (RR), and heart rate (HR).

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Zheng (Jimmy) Xie, MD, PhD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2022-04-21
Completion
2022-04-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954157 on ClinicalTrials.gov