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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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.
• Устройство Hi-Ox device
  The Hi-Ox mask is connected to a portable oxygen concentrator.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

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

Идентификаторы

NCT: NCT06928506 · 21-6203-HiOxSR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗