NCT04905888

Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Peter Lindholm · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-08
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-05-28
• Last updated: 2024-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study