Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

Sponsor
Peter Lindholm (Other)
Overall Status
Recruiting
CT.gov ID
NCT04905888
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
25.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
hbohbo
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 :
Nov 8, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Exercise tolerance [3 months]

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

Secondary Outcome Measures

  1. Excercise tolerance walk test [3 months]

    6 minute walk test, in meters

  2. Dyspnea perception 1 [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 [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 [3 months]

    Spirometry FEV1 (L) FEV1 %predicted FVC (L) FVC %predicted PEF (l/Min) PEF %predicted

  5. Pulmonary function test 2 [3 months]

    Lung Diffusion Capacity DLCO (ml/min/mmHg) DLCO %predicted

  6. V̇A/Q̇ matching measured with magnetic resonance imaging [3 months]

    pulmonary ventilation/perfusion matching with Lung heterogeneity expressed as relative dispersion in ventilation and perfusion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Univeristy of California San DiegoLa JollaCaliforniaUnited States92093

Sponsors and Collaborators

  • Peter Lindholm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Lindholm, Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT04905888
Other Study ID Numbers:
  • HRPP210260
First Posted:
May 28, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Peter Lindholm, Professor, University of California, San Diego
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021