Effect of Hi-OxSR for the Treatment of Post COVID Condition

Official title

RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hi-OxSR for the Treatment of Post COVID Condition (RECLAIM-HiOxSR)

Overview

The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction. Carbon dioxide (CO2) has been proposed as a potential treatment for persistent immune activation as there is evidence that CO2 has antioxidant, anti-inflammatory, and anti-cytokine effects. We conducted a pilot study assessing the open label use of re-breathing CO2 (using Hi-OxSR) twice a day for 14 days, for the treatment of post-COVID cognitive dysfunction. Significant improvements were found in multiple cognitive assessments using TestMyBrain cognitive tests and brain fog (MSNQ) and fatigue scores. This phase 2 clinical trial seeks to build on current findings to determine the optimal effective dose of treatment (i.e. length of use, oxygen concentration, without or without CO2 rebreathing) and the safety of using Hi-OxSR in this patient population.

Detailed description

This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from COVID-19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM)

Interventions

• Device Hi-OxSR device
  The Hi-OxSR device consists of the Hi-Ox mask connected to a portable oxygen concentrator, with added tubing serving as a reservoir for rebreathed exhaled breath.
• Device Hi-Ox device
  The Hi-Ox mask is connected to a portable oxygen concentrator.

Primary outcome measures

• Simple reaction time (SRT) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool [Time frame: Baseline/Start of intervention to two months]
• Verbal paired associates (VPA) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool [Time frame: Baseline/Start of intervention to two months]

Secondary outcome measures (12)

• All cognitive performance tasks (measured by the TESTMYBRAIN.org (TMB) neuropsychology toolkit [Time frame: Baseline/start of intervention to 2 weeks, 1, 2 and 6 months]
• Brain Fog Questionnaire [Time frame: Baseline/start of intervention to 2 weeks, 1, 2 and 6 months]
• Brief Fatigue Inventory [Time frame: Baseline/start of intervention to 2 weeks, 1, 2 and 6 months]
• Short Form (SF)-36 [Time frame: Baseline/start of intervention to 2 weeks, 1, 2 and 6 months]
• Safety, adverse events and serious adverse events [Time frame: Baseline/start of intervention to 6 months]
• Symptom Checklist [Time frame: Baseline/start of intervention to 2 and 6 months]
• The DePaul Symptom Post-Exertional Malaise Short Form DSQ-PEM [Time frame: Baseline/start of intervention to 2 weeks, 1, 2 and 6 months]
• Dyspnea [Time frame: Baseline/start of intervention to 2 and 6 months]
• Mental Health - General Anxiety Assessment Form (GAD-7) [Time frame: Baseline/start of intervention to 2 and 6 months]
• Mental Health - Patient Health Questionnaire (PHQ-9) [Time frame: Baseline/start of intervention to 2 and 6 months]
• Mental Health -Post-traumatic Stress Disorder Checklist (PCL-5) [Time frame: Baseline/start of intervention to 2 and 6 months]
• Reintegration to Normal Living Index (RNLI) [Time frame: Baseline/start of intervention to 2 and 6 months]

Eligibility criteria

Inclusion criteria

• Age ≥18 years;
• Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.
• Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
• Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;
• Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
• Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
• Must be able to provide informed consent and both willing and able to comply with study requirements.
• Oxygen saturation on room air ≥92% at screening measured by pulse oximeter.

Exclusion criteria

• Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
• Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
• Contraindications to all of the study interventions;
• Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
• Currently pregnant or breastfeeding.
• Known physician diagnosis of cognitive dysfunction prior to COVID infection
• Use of an investigational drug/device or other interventions within 30 days of screening
• Use of home oxygen (O2) at baseline
• History of pulmonary hypertension
• Interstitial pulmonary fibrosis
• Moderate to severe chronic obstructive pulmonary disease (COPD)
• History of narcolepsy
• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 3 centers

• Kaye Edmonton Clinic — Edmonton
• University Health Network — Toronto
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke

Identifiers

NCT: NCT06928506 · 21-6203-HiOxSR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗