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

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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases; Covid19; Corona Virus Infection; Coagulation Disorder, Blood
• Intervention / Treatment: Device: Narrow Band ultraviolet B-Band Light; Device: non Narrow Band ultraviolet B-Band Light

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • West Jefferson Medical Center and LSUHSC-NO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

To be eligible to enroll in the study, subjects must be:

• In-Hospital
• 50 years of age or older
• Hospitalized for COVID-I9 symptoms
• At least one comorbidity.
• They have taken a COVID-19 diagnostic test.
• Peripheral 02 saturation below 94 on room air, nasal cannula or non-rebreather
• Patients may remain enrolled as long as they remain hospitalized for
• COVID-19 symptoms and receive a positive test panel for COVID-19
• during the treatment phase
• Be able to provide consent.

Exclusion Criteria:

-

To be eligible to enroll in the study, subjects must not:

• Require ventilatory support at the time of enrollment.
• Concurrent pulmonary bacterial infection
• Taking Light Sensitive Medications
• Have Lupus Diagnosis
• Enrolled in an existing Covid-19 Trial
• Taking In-patient Vitamin oral Supplementation
• Severe mental or medical disability
• History of melanoma or dysplastic nevus syndrome
• Prisoner
• Active tuberculosis or Cystic Fibrosis, Severe Chronic Obstructive Pulmonary Disease (COPD) or Pulmonary Fibrosis requiring home supplemental oxygen
• Pre-existing pulmonary hypertension
• INR > 2, LFT 6 times greater than baseline
• Stage 3b CKD or ESRD diagnosis before COVID-19 onset
• Evidence of cirrhosis
• Evidence of pre-existing vascular disorder or coagulopathy
• Irreversible bleeding disorder
• Patients who are not full code
• Taking oral light sensitizing medications (See Appendix) or using light sensitizing topical
• medication in the phototherapy treatment zones
• Taking in patient or at home Vitamin D supplementation
• Have any photosensitive skin disorder such as Systemic Lupus Erythematosus, Porphyria or
• Pseudoporphyria, Polymorphous Light Eruption Xeroderma Pigmentosa, Chronic actinic
• dermatitis, Hydroa vacciniforme, Dermatomyositis Bloom Syndrome, Rothmund Thomas
• syndrome, Cockayne Syndrome
• Requiring oxygen supplementation via CPAP/BiPAP, ventilator support, High Flow Nasal
• Prong therapy (HFNP)
• Concurrent pulmonary bacterial infection at the time of enrollment
• Previous hospital admission for COVID-19 symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phototherapy of narrow band ultraviolet Light B-Band NB-UVB; Daavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm.	Device: Narrow Band ultraviolet B-Band Light; Daily doses of NB-UVB for 8 consecutive days.; Other Names: Phototherapy
Placebo Comparator: Placebo - Light; Daavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm.	Device: non Narrow Band ultraviolet B-Band Light; Daily doses of non-NB-UVB for 8 consecutive days.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	% Patient Mortality	14 days
Mortality Rate	% Patient Mortality	28 days
WHO Ordinal Scale for Clinical Improvement	Improvement in WHO Ordinal Scale	14 days
WHO Ordinal Scale for Clinical Improvement	Improvement in WHO Ordinal Scale	28 days
Length of Hospital Stay	Days from Treatment to Discharge	28 days
Rate of Escalation to the ICU	% of Patients Escalating to the ICU	day 14
Rate of Ventilator Support (intubation) requirement	% of Patients Requiring Ventilator Support (intubation)	day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Improved Immune Regulation as measured by (Any 3 of These):	Increased ratio of CD8 perforin to Monocyte IL6,; Increased ratio ofNK perforin to Monocyte IL6; Increased ratio of CD4 lFNg to Monocyte IL6; Increased ratio of CD8 perforin to Monocyte TNF; Increased ratio ofNK perforin to Monocyte TNF, and; Increased ratio of CD4 IFNg to Monocyte TNF	28 days
Rate of Stabilization of the Immune Dysregulation (all 3 of These)	Decreased Th l and Th 17;; Increased Th2;; Increased circulating regulatory T Cells	28 days
Average Reduction in Inflammatory Markers:	HS-CRP (mg/L)	28 days
Average Reduction in Inflammatory Markers:	LDH (units per liter (U/L))	28 days
Average Reduction in Inflammatory Markers:	Ferritin (micrograms/L)	28 days
Improved Hemostatic Regulation by D-dimer Reduction	D-dimer (ng/mL)	28 days
Improved Hemostatic Regulation by reduce PTT	Partial Thromboplastin Time (PTT) Test	28 days
Average Reduced Viral Load.	Reduced viral load (copies/mL)	28 days
Average and Categorical Increase in Vitamin D:	25(OH)D hydroxyvitamin D1. % of Patients Improving from Critical Deficiency (min. of 20ng/ml); ii. % of Patients Improving from Insufficiency (at min. of 30ng/ml);; Active 1,25-dihydroxyvitamin D and i. % of Patients with Improvement from Insufficient (at min. of 18pg/ml);	28 days
% of Patients with a Change in oxygen requirement	Non-invasive positive pressure support (BiPAP & CPAP); Discharge from the ICU; Removal from Ventilator Support	28 days
Average Temperature	(Average for each day) - Hospital Staff; (Highest Record of the day) - Hospital Staff	28 days
Average Length of Hospitalization	Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization	28 days

Collaborators and Investigators

• Sponsor: Cytokind, Inc.
• Collaborators: Baylor College of Medicine; Louisiana State University Health Sciences Center in New Orleans; West Jefferson Medical Center
• Investigators: Principal Investigator: Frank H Lau, MD, Louisiana State University Health Sciences Center in New Orleans

Publications and helpful links

General Publications

• Lau FH, Powell CE, Adonecchi G, Danos DM, DiNardo AR, Chugden RJ, Wolf P, Castilla CF. Pilot phase results of a prospective, randomized controlled trial of narrowband ultraviolet B phototherapy in hospitalized COVID-19 patients. Exp Dermatol. 2022 Jul;31(7):1109-1115. doi: 10.1111/exd.14617. Epub 2022 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin D; Immune Dysregulation; NB-UVB; Narrow Band Ultraviolet Light B-Band
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; Hemorrhagic Disorders; COVID-19; Coronavirus Infections; Hemostatic Disorders; Blood Coagulation Disorders; Autoimmune Diseases
• Other Study ID Numbers: TPL0001-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No