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

About this trial

Last updated 4 years ago

Study ID

TPL0001-02

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

50 to 110 Years

All Sexes

Trial Timing

Ended 4 years ago

What is this trial 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.

What are the participation requirements?

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