Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela
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|ClinicalTrials.gov Identifier: NCT04905888|
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : November 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Combination Product: Hyperbaric oxygen therapy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||hbo|
|Masking:||None (Open Label)|
|Official Title:||Hyperbaric Oxygen Therapy for Long COVID Patients With Pulmonary Sequela - Pilot Study|
|Actual Study Start Date :||November 8, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
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.
- Exercise tolerance [ Time Frame: 3 months ]Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)
- Excercise tolerance walk test [ Time Frame: 3 months ]6 minute walk test, in meters
- 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
- 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
- Pulmonary function test 1 [ Time Frame: 3 months ]Spirometry FEV1 (L) FEV1 %predicted FVC (L) FVC %predicted PEF (l/Min) PEF %predicted
- Pulmonary function test 2 [ Time Frame: 3 months ]Lung Diffusion Capacity DLCO (ml/min/mmHg) DLCO %predicted
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905888
|Contact: Peter Lindholm, MD PhDfirstname.lastname@example.org|
|Contact: Ann Elliott, PhDemail@example.com|