Status:
COMPLETED
Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
Lead Sponsor:
Cytokind, Inc.
Collaborating Sponsors:
Louisiana State University Health Sciences Center in New Orleans
Baylor College of Medicine
Conditions:
Covid19
Corona Virus Infection
Eligibility:
All Genders
50-110 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- \-
- 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
- \-
- 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04818970
Start Date
May 21 2021
End Date
December 1 2021
Last Update
June 15 2022
Active Locations (1)
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1
West Jefferson Medical Center and LSUHSC-NO
New Orleans, Louisiana, United States, 70112