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Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

Primary Purpose

Covid19

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hyperbaric oxygen therapy

About this trial

This is an interventional treatment trial for Covid19 focused on measuring hyperbaric oxygen, hyperbaric oxygen therapy, long covid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Univeristy of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hyperbaric oxygen therapy

Control

Arm Description

Treatment with hyperbaric oxygen

Control, no treatment.

Outcomes

Primary Outcome Measures

Exercise tolerance

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

Secondary Outcome Measures

Excercise tolerance walk test

6 minute walk test, in meters

Dyspnea perception 1

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

Dyspnea perception 2

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

Pulmonary function test 1

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

Pulmonary function test 2

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

V̇A/Q̇ matching measured with magnetic resonance imaging

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

Full Information

NCT ID

NCT04905888

First Posted

May 25, 2021

Last Updated

February 2, 2023

Sponsor

Peter Lindholm

1. Study Identification

Unique Protocol Identification Number

NCT04905888

Brief Title

Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

Official Title

Hyperbaric Oxygen Therapy for Long COVID Patients With Pulmonary Sequela - Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Suspended

Why Stopped

Closure/ move of MRI facility.

Study Start Date

November 8, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter Lindholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

hyperbaric oxygen, hyperbaric oxygen therapy, long covid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

hbo

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyperbaric oxygen therapy

Arm Type

Experimental

Arm Description

Treatment with hyperbaric oxygen

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control, no treatment.

Intervention Type

Combination Product

Intervention Name(s)

Hyperbaric oxygen therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Exercise tolerance

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Excercise tolerance walk test

Description

6 minute walk test, in meters

Time Frame

3 months

Title

Dyspnea perception 1

Description

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

Time Frame

3 Months

Title

Dyspnea perception 2

Description

Time Frame

3 Months

Title

Pulmonary function test 1

Description

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

Time Frame

3 months

Title

Pulmonary function test 2

Description

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

Time Frame

3 months

Title

V̇A/Q̇ matching measured with magnetic resonance imaging

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Univeristy of California San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

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