Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Se… (NCT06113679) | Clinical Trial Compass
TerminatedNot Applicable
Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting
Stopped: Enrollment stopped by Sponsor following interim analysis data review.
United States41 participantsStarted 2023-10-30
Plain-language summary
Duration of Treatment: 7 days, 2 times per day.
Following Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via in clinic visits at week 2/day 8 (+3/-0 days) and Week 6 / day 36, (+3/-3days). Subjects will receive a weekly televisit during Week 3 / day 15 (+3/-3), Week 4 / day 22 (+3/-3), and Week 5 / day 29 (+3/-3).
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. History of confirmed diagnosis of SARS-CoV-2 infection or COVID-19 per section 9.4.
✓. PCC (per protocol definition) with cough and at least 2 of the 3 additional qualifying symptoms that have been determined not associated with another disease state:
✓. Negative for COVID-19 via rapid antigen test.
✓. Minimum time period from onset of symptoms (or from date of positive test for asymptomatic) - 3 months.
✓. Minimum duration of symptoms at least 2 months, continuous or intermittent.
✓. Males or females, 22 years of age and older on the date of enrollment.
✓. Provides written informed consent prior to initiation of any study procedures.
✓. Be able to understand and agrees to fully comply with defined and described study procedures and be available for all study visits for the entire study duration.
Exclusion criteria
✕. Positive test for SARS-CoV-2 infection or COVID-19 within the past 30 days.
✕. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
✕. History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within 30 days of study day, V1.
✕. History of any systemic antiviral therapies within 30 days of study day, V1.
✕. History of oral or parenteral corticosteroid use within 30 days of study day, V1. Active use of nasal or inhalable corticosteroids is also exclusionary. Topical steroids are not exclusionary.
✕. History of any chronic medical condition that has required adjustments to the type, dose, or schedule of medical treatments within 30 days of study day, V1.
✕. Requirement to use narcotic medication for analgesia.