- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905888
Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela
Hyperbaric Oxygen Therapy for Long COVID Patients With Pulmonary Sequela - Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- Univeristy of California San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyperbaric oxygen therapy
Treatment with hyperbaric oxygen
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise tolerance
Time Frame: 3 months
|
Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excercise tolerance walk test
Time Frame: 3 months
|
6 minute walk test, in meters
|
3 months
|
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 Months
|
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 |
3 Months
|
Pulmonary function test 1
Time Frame: 3 months
|
Spirometry FEV1 (L) FEV1 %predicted FVC (L) FVC %predicted PEF (l/Min) PEF %predicted
|
3 months
|
Pulmonary function test 2
Time Frame: 3 months
|
Lung Diffusion Capacity DLCO (ml/min/mmHg) DLCO %predicted
|
3 months
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- HRPP210260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on Hyperbaric oxygen therapy
-
National Baromedical ServicesMayo Clinic; Dartmouth-Hitchcock Medical Center; Eastern Virginia Medical School and other collaboratorsCompletedCarcinoma, Squamous Cell | Cancer of the Head and NeckUnited States
-
Bayside HealthNational Health and Medical Research Council, Australia; Monash UniversityCompletedTibial Fracture | Soft Tissue InjuryAustralia, Sweden, Chile, United States, Austria, India, Italy, Portugal, Czechia
-
Louisiana State University Health Sciences Center...U.S. Army Medical Research and Development CommandUnknownTraumatic Brain Injury | Post-Concussion SyndromeUnited States
-
Omar AljitawiCompleted
-
University of British ColumbiaUnknown
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
St. Joseph's Healthcare HamiltonUniversity Health Network, Toronto; Judy Dan Research and Treatment Centre...CompletedDiabetes Mellitus | Chronic Ulcers of the Lower LimbCanada
-
UMC UtrechtThe Netherlands Cancer InstituteCompletedBreast Cancer | Radiation ToxicityNetherlands
-
University of VersaillesAssistance Publique - Hôpitaux de ParisTerminatedCarbon Monoxide PoisoningFrance
-
Assaf-Harofeh Medical CenterUnknownChronic Renal FailureIsrael