Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Autoimmune Diseases
  • Coagulation Disorder, Blood
  • Corona Virus Infection
  • COVID-19
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 1:1 Randomized Placebo Control TrialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-BlindPrimary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 110 years
Gender
Both males and females

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 therap...

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).

Tracking Information

NCT #
NCT04818970
Collaborators
  • Louisiana State University Health Sciences Center in New Orleans
  • Baylor College of Medicine
  • West Jefferson Medical Center
Investigators
Principal Investigator: Frank H Lau, MD Louisiana State University Health Sciences Center in New Orleans