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

Prior treatment

• Known physician diagnosis of cognitive dysfunction prior to COVID infection
• Use of an investigational drug/device or other interventions within 30 days of screening

Other illness

• 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;
• History of pulmonary hypertension
• 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.

Other

• 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.
• Use of home oxygen (O2) at baseline
• Interstitial pulmonary fibrosis

• 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.