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 range
22 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Individuals \< age 22 at consent.
. 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.