Clinical trial NCT04818970: Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Corona Virus Infection
Autoimmune Diseases
Coagulation Disorder, Blood
Keywords: Narrow Band Ultraviolet Light B-Band
NB-UVB
Immune Dysregulation
Vitamin D
Lead sponsor: Cytokind, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
name: Baylor College of Medicine
name: West Jefferson Medical Center
First posted: 2021-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Randomized Placebo Control Trial
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Mortality Rate
timeFrame: 14 days
measure: Mortality Rate
timeFrame: 28 days
measure: WHO Ordinal Scale for Clinical Improvement
timeFrame: 14 days
measure: WHO Ordinal Scale for Clinical Improvement
timeFrame: 28 days
measure: Length of Hospital Stay
timeFrame: 28 days
measure: Rate of Escalation to the ICU
timeFrame: day 14
measure: Rate of Ventilator Support (intubation) requirement
timeFrame: day 28
Secondary outcomes:
measure: Rate of Improved Immune Regulation as measured by (Any 3 of These):
timeFrame: 28 days
measure: Rate of Stabilization of the Immune Dysregulation (all 3 of These)
timeFrame: 28 days
measure: Average Reduction in Inflammatory Markers:
timeFrame: 28 days
measure: Average Reduction in Inflammatory Markers:
timeFrame: 28 days
measure: Average Reduction in Inflammatory Markers:
timeFrame: 28 days
measure: Improved Hemostatic Regulation by D-dimer Reduction
timeFrame: 28 days
measure: Improved Hemostatic Regulation by reduce PTT
timeFrame: 28 days
measure: Average Reduced Viral Load.
timeFrame: 28 days
measure: Average and Categorical Increase in Vitamin D:
timeFrame: 28 days
measure: % of Patients with a Change in oxygen requirement
timeFrame: 28 days
measure: Average Temperature
timeFrame: 28 days
measure: Average Length of Hospitalization
timeFrame: 28 days
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: West Jefferson Medical Center and LSUHSC-NO
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Frank H Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.