RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Hi-OxSR device for Long COVID

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.

Official registry: https://clinicaltrials.gov/study/NCT06928506 · University Health Network, Toronto · enrollment listed as 120

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Hi-OxSR device, or Hi-Ox device. The registry lists allocation as randomized. 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.

They plan to enroll about 120 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: Hi-OxSR device, Hi-Ox device

Primary outcome (registry wording): Simple reaction time (SRT) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool

Who it is for (from inclusion criteria)

Ages 18 Years to any
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
Oxygen saturation on room air ≥92% at screening measured by pulse oximeter

Who the registry excludes

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 treatment trial (co-enrolment in an watch-and-measure (no experimental treatment required) 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

Public study contact (from the registry)

suzanne Cohen

1-866-673-2524

reclaim@uhn.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Kaye Edmonton Clinic — Edmonton, Alberta, Canada (recruiting)
University Health Network — Toronto, Ontario, Canada (recruiting)
Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (recruiting)

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FAQ about this NCT record

Is NCT06928506 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06928506?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06928506?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary