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

Cytokind

Status

Completed

Conditions

Corona Virus Infection

Covid19

Coagulation Disorder, Blood

Autoimmune Diseases

Treatments

Device: non Narrow Band ultraviolet B-Band Light

Device: Narrow Band ultraviolet B-Band Light

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04818970

TPL0001-02

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 patients

Sex

All

Ages

50 to 110 years old

Volunteers

No Healthy Volunteers

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