NCT04818970

Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients

Adaptive Photo-Protection Trial: To Demonstrate the Safety and Efficacy of NB-UVB Light Therapy to Improve Outcomes in Hospitalized High-risk Patients With COVID-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cytokind, Inc. · Industry
• Sex: All
• Age: 50 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to evaluate the translational application of the safe and effective treatment of Narrow-Band Ultraviolet light B-band (NB-UVB) to high-risk COVID-19 patients in an effort to improve their immune and hemostatic imbalance to increase survival and improve outcomes.

Detailed description

Study Design This is a multi-center, double blind, randomized control trial designed to assess the safety and efficacy of daily NB-UVB light for patients presenting to site hospitals over the age of 50 with a positive COVID-19 panel and at least one comorbidity. This trial provides adjunctive therapy and no in-hospital treatments need to be modified in any way. The sponsor and the centers acknowledge standards of care are actively evolving and this trial is not intended to interfere in any form. Double Blind: Patient and Health care provider will be blinded to the treatment vs. placebo by use of a non-NB-UVB light card. All dosing and times for treatment and placebo will be calculated the same methods. Arm A: Control: Will receive non-NB-UVB light during the Treatment Period. Arm B: Treatment: Will receive NB-UVB light during the Treatment Period. Treatment Phase (Days 1-8): Treatment Schedule will be identical for arm A and B. Follow Up Phase (Days 9-28 or discharge): Follow-up will be identical for arms A and B. Blood Draw Schedule: Blood draws are to be performed after enrollment, before the first treatment day 1 and on days 3, 5, 8, 14 and day of discharge (if prior to day 14 unless blood draw has already occurred within one day of discharge).

Conditions

• Covid19
• Corona Virus Infection
• Autoimmune Diseases
• Coagulation Disorder, Blood

Interventions

Type	Name	Description
DEVICE	Narrow Band ultraviolet B-Band Light	Daily doses of NB-UVB for 8 consecutive days.
DEVICE	non Narrow Band ultraviolet B-Band Light	Daily doses of non-NB-UVB for 8 consecutive days.

Timeline

• Start date: 2021-05-21
• Primary completion: 2021-10-31
• Completion: 2021-12-01
• First posted: 2021-03-26
• Last updated: 2022-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study