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Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

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ClinicalTrials.gov Identifier: NCT04905888
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Peter Lindholm, University of California, San Diego

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Combination Product: Hyperbaric oxygen therapy Phase 2

Detailed Description:

Long COVID or Post-Acute Sequelae of SARS-CoV-2 infection (PASC) is current terms for patients demonstrating fatigue, chest pain, exertion malaise, dyspnea, cognitive dysfunction, and headaches, just to name a few symptoms that can last more than 12-weeks after the initial infection of SARS-CoV-2. Pulmonary symptoms of dyspnea and exercise intolerance may be due to pulmonary gas exchange derangement, which could be from hypoxic pulmonary vasoconstriction (HPV) inhibition due to lingering inflammatory processes. Hyperbaric oxygen (HBO) has known anti-inflammatory effects, shown in multiple organ systems, and recently reported in case studies to improve outcomes of acute COVID-19 pneumonitis. If there is pulmonary inflammation it is possible that HBO can improve pulmonary gas exchange by restoring HPV. To test this hypothesis, we plan to perform a mechanistic study on V̇A/Q̇ matching in Long COVID patients with lingering pulmonary symptoms. The etiology of symptoms is unknown, but it is probable that the inflammatory processes associated with COVID-19 may inhibit HPV.

This is an open, randomized, controlled clinical trial with hyperbaric oxygen therapy delivered by a hyperbaric chamber as the intervention. Twelve patients will receive ten HBO therapy (HBOT) over a 2-3-week period, and twelve patients will serve as controls and receive no HBOT. Each HBOT session will administer oxygen (O2) at 2.4 atmospheres absolute pressure (ATA) (100% O2) for 90 minutes in a hyperbaric chamber.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: hbo
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Long COVID Patients With Pulmonary Sequela - Pilot Study
Actual Study Start Date : November 8, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy
Treatment with hyperbaric oxygen
 Combination Product: Hyperbaric oxygen therapy
Subjects randomized to treatment will receive up to ten 90 minute treatments with hyperbaric oxygen over a 2-3 week period.
No Intervention: Control
Control, no treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: 3 months ]
    Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)


Secondary Outcome Measures :
  1. Excercise tolerance walk test [ Time Frame: 3 months ]
    6 minute walk test, in meters

  2. Dyspnea perception 1 [ Time Frame: 3 Months ]
    UCSD Shortness of breath (SOB) 24 questions using a 0-6-point scale per question Total score (0-120) The higher the score the greater the dyspnea

  3. Dyspnea perception 2 [ Time Frame: 3 Months ]

    PROMIS dyspnea questionnaire/scales (Patient-Reported Outcomes Measurement Information System).

    Shortness of Breath in general (0-10) Intensity of Shortness of breath (0-10) Frequency of Shortness of breath (0-10) Duration of Shortness of breath (0-10) The higher the score the greater the dyspnea


  4. Pulmonary function test 1 [ Time Frame: 3 months ]
    Spirometry FEV1 (L) FEV1 %predicted FVC (L) FVC %predicted PEF (l/Min) PEF %predicted

  5. Pulmonary function test 2 [ Time Frame: 3 months ]
    Lung Diffusion Capacity DLCO (ml/min/mmHg) DLCO %predicted

  6. V̇A/Q̇ matching measured with magnetic resonance imaging [ Time Frame: 3 months ]
    pulmonary ventilation/perfusion matching with Lung heterogeneity expressed as relative dispersion in ventilation and perfusion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 65 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

Exclusion Criteria:

  • 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
  • Active or uncontrolled cancer diagnosis.
  • Active or uncontrolled psychiatric disease.
  • Acute upper respiratory tract infection
  • History of exposure to bleomycin
  • Taking the following concomitant medications: PDE5 inhibitors, carbonic anhydrase inhibitors, beta blockers, alpha blockers, nitrates.
  • MRI incompatibilities- a cardiac pacemaker, metal fragments in the eyes, skin, body; heart valve replacement, brain clips, venous umbrella, intercranial bypass, renal, aortic clips, prosthetic devices for middle ear, eye, joint or penile implants, joint replacements; hearing aid, neurostimulator, insulin pump, I.U.D, pregnant or trying to become pregnant, shunts/stents, metal mesh/coil implants; metal plate/pin/screws/wires, any other implants; permanent eyeliner/eyebrows with metal containing dyes, dental work within 6 weeks, claustrophobia.
  • Involved in another clinical trial that does not allow enrollment in other clinical trials.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905888


Contacts
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Contact: Peter Lindholm, MD PhD 6508230735 plindholm@health.ucsd.edu
Contact: Ann Elliott, PhD aelliott@health.ucsd.edu

Locations
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United States, California
Univeristy of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Peter Lindholm, MD, PhD    650-823-0735    plindholm@health.ucsd.edu   
Contact: Peter Lindholm    6508230735    plindholm@health.ucsd.edu   
Sponsors and Collaborators
Peter Lindholm
More Information
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Responsible Party: Peter Lindholm, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04905888    
Other Study ID Numbers: HRPP210260
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Peter Lindholm, University of California, San Diego:
hyperbaric oxygen
hyperbaric oxygen therapy
long covid
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases