Status:
WITHDRAWN
Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela
Lead Sponsor:
Peter Lindholm
Conditions:
Covid19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04905888
Start Date
November 8 2021
End Date
December 31 2023
Last Update
January 23 2024
Active Locations (1)
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1
Univeristy of California San Diego
La Jolla, California, United States, 92093