Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19

NCT04662671 | Completed Results DMC FDA Device

• 1 other identifier: EB-P12-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19.

Conditions

COVID19

Outcome Measures

Primary Outcomes (2)

• Primary Safety Measure

  Number of Participants with device-related serious adverse events or any patterns of severity ≥2 device-related adverse events in the same SOC grouping of Preferred Terms based on Medical Dictionary for Regulatory Activities (MedDRA) coding, as determined throughout the course of the study.

  Baseline thru Day 8

• Primary Efficacy Measure

  Time weighted average change in viral load from baseline by RT-qPCR from Day 1 to Day 8.

  Baseline to Day 8

Secondary Outcomes (2)

• Proportion of Subjects Demonstrating Clearance of Viral Infection

  Days 1, 3, 5 and 8

• Median Time to Alleviation of Symptoms

  Daily through day 8

Study Arms (2)

RD-X19 Device

EXPERIMENTAL

Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.

Device: RD-X19

Sham Device

SHAM COMPARATOR

Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.

Device: RD-X19

Interventions

RD-X19 DEVICE

Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.

RD-X19 Device; Sham Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive for SARS-CoV-2 antigen via nasal swab at or within the past 24 hours of the screening visit detected using an FDA authorized SARS-CoV-2 antigen test.
• Onset of signs and symptoms consistent with COVID-19\* no longer than within the past 3 days\* and have either a) a fever of at least 100 °F or b) at least two moderate or severe symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, fatigue, and nausea) at the time of screening.
• Provides written informed consent prior to initiation of any study procedures.
• Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
• Agrees to the collection of nasopharyngeal swabs, oropharyngeal swabs, oral saliva specimen collection and venous blood specimens per protocol.
• Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse, Listerine) or mouthwashes of any kind during the study.
• Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment.
• No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms\*.
• No physical or mental conditions or attributes at the time of screening, which in the opinion of the PI, will prevent full adherence to, and completion of, the protocol.

You may not qualify if:

• Positive urine pregnancy test at screening.
• Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
• Presence of self-reported or medically documented uncontrolled significant medical or psychiatric condition(s) other than COVID-19.
• Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen, hepatitis C virus antibody, or HIV-1 antibodies at screening.
• Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 month of Study Day 1.
• COVID-19 signs associated with acute respiratory distress or imminent serious medical outcomes. \^\^
• BMI ≥36
• Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled.
• Has participated in another investigational study involving any intervention for SARS-CoV-2/COVID- 19 within the past 6 months or any clinical trial with interventional investigational product within 30 days of screening.
• Currently enrolled in or plans to participate in another clinical trial with an interventional investigational agent that will be received during the studyperiod.
• History of hospitalization within the past 60 days.
• History of systemic antiviral therapies within the past 30 days.
• Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to nitrites, nitrates, or sun exposure.
• Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion of the investigator would interfere with device use, or intra-oral metal body piercings that cannot be removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece.

Sponsors & Collaborators

• EmitBio Inc.: lead

Study Sites (2)

Site 2

Miami, Florida, 33134, United States

Location

Site 1

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: EmitBio, Inc.

nstasko@emitbio.com

(919) 321-1734

Study Officials

• EB-P12-01 Study Director

  EmitBio

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, sham-controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be conducted as a randomized, double-blind, sham-controlled study in SARS-CoV-2 infected individuals with outpatient COVID-19. Subjects will be randomized 2:1 RD-X19 to Sham Device treatment arms.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 10, 2020
• Study Start: November 18, 2020
• Primary Completion: December 9, 2020
• Study Completion: January 30, 2021
• Last Updated: September 8, 2022
• Results First Posted: September 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)