Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting

NCT06113679 | Terminated FDA Device

• 2 other identifiers: EB-PCC-01Pro00074175
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Post COVID-19 Condition (PCC)

Outcome Measures

Primary Outcomes (1)

• Primary Symptom Improvement

  Improvement of one or more primary PCC signs/symptom(s) - cough, fatigue, shortness of breath, cognitive dysfunction/brain fog as compared to sham, with or without fluctuation.

  5 weeks

Secondary Outcomes (1)

• Secondary Symptom Improvement

  5 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Device: RDX-19

Sham

SHAM COMPARATOR

Device: RDX-19

Interventions

RDX-19 DEVICE

RD-X19 device with a 5 minute, 32 J/cm2 dose, 2X/day, 7 days. Each treatment at least 6 hours apart.

Active; Sham

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• fatigue
• shortness of breath
• cognitive dysfunction/brain fog.
• 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.
• Agrees to perform self-treatment twice a day, separated by ≥ 6 hours during the treatment period.
• Agrees to maintain current medications without the addition of any new medications for relief of signs and symptoms of PCC during the entire study period, and, if used, to report ALL such medications (including over the counter and home remedies) to the study staff.
• No uncontrolled disease process (chronic or acute) that could be attributable to qualifying symptoms.
• No physical or mental conditions or attributes at the time of screening, which in the opinion of the PI, will prevent full adherence to, and completion of, the protocol.

You may not qualify if:

• A subject with any of the following criteria will be excluded from participation in this study:
• 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 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.
• History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure.
• Presence of any oral abnormality (e.g., including, but not limited to, ulcer, oral candidiasis, oral mucositis, gingivitis, history of frequent recurrent aphthous ulcers, burning mouth syndrome, dry mouth syndrome, a disease that can result in xerostomia (e.g., Sjogren's syndrome), or other oral disorder that in the opinion of the investigator would interfere with device use and evaluation.
• Any intra-oral metal body piercings that cannot be removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece.
• Any individual without teeth or with a dental malformation that precludes directed use of the device as intended.
• Use of new medications to treat PCC symptoms within the 30 days prior to V1.
• Currently enrolled in or plans to participate in another clinical trial with a therapeutic investigational agent for any medical indication that will be received during the study period.
• Has participated in an investigational treatment trial for PCC within the past 30 days.

Sponsors & Collaborators

• EmitBio Inc.: lead
• NAMSA: collaborator

Study Sites (2)

Site 2_WellNow Urgent Care and Research

East Amherst, New York, 14051, United States

Location

Site 1_Helios - Physician Quality Care

Milan, Tennessee, 38358, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, 1:1 Sham Control

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 2, 2023
• Study Start: October 30, 2023
• Primary Completion: May 24, 2024
• Study Completion: June 21, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (2)