Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

NCT04905888 | Withdrawn Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: HRPP210260
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study in 24 subjects where half will be randomized to 10 treatments with hyperbaric oxygen (HBO). It will primarily study pulmonary sequelae with imaging and physiological measurements (low dose chest computer tomography (CT), Ventilation/perfusion with magnetic resonance imaging (VA/Q MRI), cardiopulmonary exercise testing with pulse oximetry (SpO2) and spirometry including diffusion capacity for carbon monoxide (DLCO). The target patient group will be previously healthy whom have had covid-19 with lingering symptoms past 12 weeks of recovery from the acute phase.

Conditions

Covid19

Keywords

hyperbaric oxygen; hyperbaric oxygen therapy; long covid

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)

  3 months

Secondary Outcomes (6)

• Excercise tolerance walk test

  3 months

• Dyspnea perception 1

  3 Months

• Dyspnea perception 2

  3 Months

• Pulmonary function test 1

  3 months

• Pulmonary function test 2

  3 months

Study Arms (2)

Hyperbaric oxygen therapy

EXPERIMENTAL

Treatment with hyperbaric oxygen

Combination Product: Hyperbaric oxygen therapy

Control

NO INTERVENTION

Control, no treatment.

Interventions

Hyperbaric oxygen therapy COMBINATION_PRODUCT

Subjects randomized to treatment will receive up to ten 90 minute treatments with hyperbaric oxygen over a 2-3 week period.

Hyperbaric oxygen therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• COVID-19 at least 12 weeks prior, +PCR test and/or documented clinical symptoms
• Desaturate to \<94% during the 6-MWT and/or have abnormal spirometry or DLCO values below the lower limit of normal (LLN)
• Active life-style before contracting COVID-19

You may not qualify if:

• Pregnant or lactating women
• Individuals that are unable walk or get in and out of bed by themselves
• Weighing over 300 lbs. or Body mass index (BMI) \>30
• Inability to provide written informed consent
• Inability or unwillingness to adhere to 10 HBOT treatment sessions over a 2 to 3 week- time period or to complete follow up questionnaires/telephone contacts.
• Claustrophobia and inability to enter the hyperbaric chamber for session.
• Inability to effectively equalize the middle ear during ambient pressure changes. History of tympanic membrane perforation, head and neck surgery with compromised Eustachian tube function, including tracheostomy, mastoidectomy, middle ear surgical procedures and cochlear implants.
• History of pulmonary disease prior to COVID-19 including asthma, chronic obstructive pulmonary disease (COPD), bullous lung disease, previous thoracotomy, pneumothorax or history of pneumothorax prior to having COVID-19.
• History of cardiovascular disease prior to having COVID-19.
• History of type 1 or 2 diabetes prior to having COVID-19
• History of neurovascular diseases (e.g. recent stroke) prior to having COVID-19
• History of uncontrolled hypertension prior to having COVID-19
• History of retinitis pigmentosa prior to having COVID-19
• History of renal disease prior to having COVID-19
• History of seizure disorder prior to having COVID-19

Sponsors & Collaborators

• Peter Lindholm: lead

Study Sites (1)

Univeristy of California San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Hyperbaric Oxygenation

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: hbo

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: November 8, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)