Post COVID-19 Condition (PCC) Clinical Trial
Official title:
EB-PCC-01, A Pilot Randomized, Sham Controlled Safety and Efficacy Study of the EmitBio™ RD-X19 Treatment Device in Subjects With Post COVID-19 Condition (PCC) in the Outpatient Setting
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).
Subjects who have been pre-screened will be approached regarding the study and scheduled for a Screening Visit (V0). During the Screening Visit (V0) subjects will be consented and screened. To be considered eligible, subjects must present evidence of prior SARS-CoV-2 infection or COVID-19 via in clinic testing. Subject screening will include symptom assessments, medical history, and collection of laboratory samples. Following receipt of subject lab results, subjects who meet inclusion/exclusion criteria will be scheduled for Visit 1. At V1 eligible subjects will be randomized 1:1 to receive device or sham. Randomization will be performed. During V1 which is Day 1 of treatment, subjects will receive in clinic training on the use of the device. Subjects will administer the first treatment while supervised in the clinic. The second treatment on Day 1 will be at home via a televisit performed by eligible clinical site staff. At V1 subjects will identify and grade symptoms on a 4 point scale for both primary and secondary PCC symptoms. This evaluation will serve as a baseline for subsequent comparative assessments using the Patients Global Impression of Change 1(PGIC-1) scale. After the first in clinic treatment, subjects will self treat at home during a prescheduled televisit. Televisits may be performed via web based telehealth applications or telephone with eligible clinical site staff. At each televisit, subjects will be asked questions regarding possible side effects and adverse events. Daily during the telehealth visit that occurs during treatment, clinical site staff will assess symptoms using the PGIC 1 scale and will assess their hours of upright activity.. Follow up will be performed for 5 weeks after treatment completion. During follow up telehealth visits subjects will be asked about any symptomswhich will include the PGIC 1 assessment and hours of upright activity. At follow up week 2 (day 8 +3/- 0 days) subjects will return to the clinic for in person visual and physical health assessments, changes since last visit, safety assessments, and a blood draw. During the in clinic visit the subject will complete the PGIC 1 assessment and hours of upright activity assessment. During weeks 3, 4, and 5, subjects will be followed via televisits, with each visits cheduled on approximately the same day each week. During the televisits, subjects will be asked questions regarding adverse events, the PGIC-1 assessment and hours of upright activity assessment will be performed.. At follow up week 6 (+/-3 days), subjects will return to the clinic for in person visual and physical health assessments, changes since last visit, safety assessments, and a blood draw. While in clinic, subjects will complete the final PGIC 1 scale, the PGIC 2 scale, and upright activity assessments. The PGIC 2 assessment is additional data not associated with an endpoint. Subjects will return the study devices.. Additional data collected as a part of the study will be the measure of cytokines and chemokines before and after treatment. Hours of upright activity over the course of the study will also be reported.. Both of these assessments are reported measures but are not associated with objectives or endpoints. ;