MedTrace Logo

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

NCT06113679 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-07-05

No results posted yet for this study

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)

Interventions

DEVICE

RDX-19

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

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • EmitBio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-05-24
Completion
2024-06-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06113679 on ClinicalTrials.gov