A randomized, controlled, feasibility study of RD‐X19 in subjects with mild‐to‐moderate COVID‐19 in the outpatient setting
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Abstract
The RD‐X19 is an investigational, handheld medical device precisely engineered to emit blue light through the oral cavity to target the oropharynx and surrounding tissues. At doses shown to be noncytotoxic in an in vitro three‐dimensional human epithelial tissue model, the monochromatic visible light delivered by RD‐X19 results in light‐initiated expression of immune stimulating cytokines IL‐1α and IL‐1β, with corresponding inhibition of severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) replication. A single exposure of 425 nm blue light at 60 J/cm 2 led to greater than 99% reductions against all SARS‐CoV‐2 strains tested in vitro, including the more transmissible (Alpha) and immune evasive (Beta) variants. These preclinical findings along with other studies led to a randomized, double‐blind, sham‐controlled early feasibility study using the investigational device as a treatment for outpatients with mild to moderate coronavirus disease 2019 (COVID‐19). The study enrolled 31 subjects with a positive SARS‐CoV‐2 antigen test and at least two moderate COVID‐19 signs and symptoms at baseline. Subjects were randomized 2:1 (RD‐X19: sham) and treated twice daily for 4 days. Efficacy outcome measures included assessments of SARS‐CoV‐2 saliva viral load and clinical assessments of COVID‐19. There were no local application site reactions and no device‐related adverse events. At the end of the study (day 8), the mean change in log 10 viral load was −3.29 for RD‐X19 and −1.81 for sham, demonstrating a treatment benefit of −1.48 logs (95% confidence internal, −2.88 to −0.071, nominal p = 0.040). Among the clinical outcome measures, differences between RD‐X19 and sham were also observed, with a 57‐h reduction of median time to sustained resolution of COVID‐19 signs and symptoms (log rank test, nominal p = 0.044).
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SciScore for 10.1101/2021.10.17.21265058: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonization of Good Clinical Practice guidelines and all applicable regulatory requirements including oversight by a local institutional review board for each trial center.
Consent: All subjects provided written informed consent before participating in the trial.Sex as a biological variable Oral Epithelial Tissue Model: Primary oral mucosal tissues derived from human buccal epithelial cells (EpiOral™ ORL-200, MatTek Corporation – 40 year old Caucasian male tissue donor) were cultured for 28 days in transwell inserts as described previously. Randomization Early Feasibility … SciScore for 10.1101/2021.10.17.21265058: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonization of Good Clinical Practice guidelines and all applicable regulatory requirements including oversight by a local institutional review board for each trial center.
Consent: All subjects provided written informed consent before participating in the trial.Sex as a biological variable Oral Epithelial Tissue Model: Primary oral mucosal tissues derived from human buccal epithelial cells (EpiOral™ ORL-200, MatTek Corporation – 40 year old Caucasian male tissue donor) were cultured for 28 days in transwell inserts as described previously. Randomization Early Feasibility Clinical Study Design: This randomized, double-blind, sham-controlled, early feasibility study was conducted in the outpatient setting at two centers in the United States. Blinding The subjects, investigators, site personnel, and EmitBio employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Gene Expression Analysis: To assess the immunomodulatory effects of 425 nm light on oral epithelial tissues, un-infected ORL-200 transwell cultures were illuminated with a single dose of 425 nm light (0 J/cm2, 3 J/cm2, 7.5 J/cm2, 15 J/cm2, 30 J/cm2, or 60 J/cm2) and incubated at 37°C, 5% CO2. Gene Expression Analysissuggested: (gene Expression Analysis Resource, RRID:SCR_017467)Statistical analyses were performed with SAS software, version 9.4 (SAS Institute Inc.). SASsuggested: (SASqPCR, RRID:SCR_003056)SAS Institutesuggested: (Statistical Analysis System, RRID:SCR_008567)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04662671 Completed Phase I/II Randomized, Dose Escalation Study to Evaluate the… NCT04557826 Completed Acute Safety and Acceptability Study of Experimental Device … Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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