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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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

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Covid19 Corona Virus Infection Autoimmune Diseases Coagulation Disorder, Blood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 Randomized Placebo Control Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-Blind

Study Groups

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Phototherapy of narrow band ultraviolet Light B-Band NB-UVB

Daavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm.

Group Type EXPERIMENTAL

Narrow Band ultraviolet B-Band Light

Intervention Type DEVICE

Daily doses of NB-UVB for 8 consecutive days.

Placebo - Light

Daavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm.

Group Type PLACEBO_COMPARATOR

non Narrow Band ultraviolet B-Band Light

Intervention Type DEVICE

Daily doses of non-NB-UVB for 8 consecutive days.

Interventions

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Narrow Band ultraviolet B-Band Light

Daily doses of NB-UVB for 8 consecutive days.

Intervention Type DEVICE

non Narrow Band ultraviolet B-Band Light

Daily doses of non-NB-UVB for 8 consecutive days.

Intervention Type DEVICE

Other Intervention Names

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Phototherapy Placebo

Eligibility Criteria

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Inclusion Criteria

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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

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No