RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hi-OxSR for the Treatment of Post COVID Condition (RECLAIM-HiOxSR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Simple reaction time (SRT) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool
研究概览
简要总结
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.
详细描述
This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from COVID-19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are not be blinded to group allocation, and will know what group they are assigned to. Participants will be masked to the hypothesis of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •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.
排除标准
- •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.
结局指标
主要结局
Simple reaction time (SRT) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool
时间窗: Baseline/Start of intervention to two months
TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test will take about 5 minutes to complete and will assess reaction time.
Verbal paired associates (VPA) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool
时间窗: Baseline/Start of intervention to two months
TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test will take about 5 minutes to complete and will assess memory.
次要结局
- All cognitive performance tasks (measured by the TESTMYBRAIN.org (TMB) neuropsychology toolkit(Baseline/start of intervention to 2 weeks, 1, 2 and 6 months)
- Brain Fog Questionnaire(Baseline/start of intervention to 2 weeks, 1, 2 and 6 months)
- Brief Fatigue Inventory(Baseline/start of intervention to 2 weeks, 1, 2 and 6 months)
- Short Form (SF)-36(Baseline/start of intervention to 2 weeks, 1, 2 and 6 months)
- Safety, adverse events and serious adverse events(Baseline/start of intervention to 6 months)
- Symptom Checklist(Baseline/start of intervention to 2 and 6 months)
- The DePaul Symptom Post-Exertional Malaise Short Form DSQ-PEM(Baseline/start of intervention to 2 weeks, 1, 2 and 6 months)
- Dyspnea(Baseline/start of intervention to 2 and 6 months)
- Mental Health - General Anxiety Assessment Form (GAD-7)(Baseline/start of intervention to 2 and 6 months)
- Mental Health - Patient Health Questionnaire (PHQ-9)(Baseline/start of intervention to 2 and 6 months)
- Mental Health -Post-traumatic Stress Disorder Checklist (PCL-5)(Baseline/start of intervention to 2 and 6 months)
- Reintegration to Normal Living Index (RNLI)(Baseline/start of intervention to 2 and 6 months)
- Blood samples(Baseline/start of intervention and 2 months)
- Fatigue Scale (adapted from the De Paul Symptom Questionnaire (DSQ2)(Baseline/start of intervention to 2 weeks, 1, 2 and 6 months)