Covid19Phase 2NCT04905888
Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela
A Phase 2 study testing Hyperbaric oxygen therapy in people with Covid19, run by Peter Lindholm at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Hyperbaric oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of California San Diego
La Jolla, California, 92093
About this study
Official title: Hyperbaric Oxygen Therapy for Long COVID Patients With Pulmonary Sequela - Pilot Study
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- hyperbaric oxygen, hyperbaric oxygen therapy, long covid
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyCombination product
Subjects randomized to treatment will receive up to ten 90 minute treatments with hyperbaric oxygen over a 2-3 week period.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Treatment with hyperbaric oxygen Receives: Combination Product: Hyperbaric oxygen therapy |
| Control | No intervention | Control, no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)
Measured: 3 months
Secondary outcomes (6)
Excercise tolerance walk test
6 minute walk test, in meters
Measured: 3 months
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
Measured: 3 Months
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
Measured: 3 Months
Pulmonary function test 1
Spirometry FEV1 (L) FEV1 %predicted FVC (L) FVC %predicted PEF (l/Min) PEF %predicted
Measured: 3 months
Pulmonary function test 2
Lung Diffusion Capacity DLCO (ml/min/mmHg) DLCO %predicted
Measured: 3 months
V̇A/Q̇ matching measured with magnetic resonance imaging
pulmonary ventilation/perfusion matching with Lung heterogeneity expressed as relative dispersion in ventilation and perfusion.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start8 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Why it stopped: Closure/ move of MRI facility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hbo
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Lindholm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Lindholm, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905888
- Sponsor's protocol ID
- HRPP210260
- Status last verified
- Jan 2024
- First submitted
- 25 May 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Long COVID Patients With Pulmonary Sequela - Pilot Study
- ClinicalTrials.gov ID
- NCT04905888
- Acronym / sponsor ID
- HRPP210260
- Conditions
- Covid19
- Keywords
- hyperbaric oxygen, hyperbaric oxygen therapy, long covid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closure/ move of MRI facility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peter LindholmUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- hbo
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Combination Product: Hyperbaric oxygen therapyTreatment with hyperbaric oxygen |
| Control | No intervention | –Control, no treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapySubjects randomized to treatment will receive up to ten 90 minute treatments with hyperbaric oxygen over a 2-3 week period. | Combination product | Hyperbaric oxygen therapy |
Primary outcome
Exercise tolerance
Time frame: 3 months
Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)
6 secondary outcomes
Excercise tolerance walk test
Time frame: 3 months
Dyspnea perception 1
Time frame: 3 Months
Dyspnea perception 2
Time frame: 3 Months
Pulmonary function test 1
Time frame: 3 months
Pulmonary function test 2
Time frame: 3 months
V̇A/Q̇ matching measured with magnetic resonance imaging
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric oxygen therapy in people with Covid19, run by Peter Lindholm at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.