Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19

NCT04966013 | Completed Results DMC FDA Device

• 1 other identifier: EB-P20-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 9

Brief Summary

This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in individuals with symptomatic COVID-19 in the outpatient setting.

Conditions

COVID19

Outcome Measures

Primary Outcomes (2)

• Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline).

  Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).

  Baseline thru Day 14

• Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline.

  Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).

  Baseline thru Day 14

Secondary Outcomes (10)

• Medically Attended Visits

  Baseline thru Day 14

• Severe Disease Progression

  Baseline thru Day 14

• Hospitalizations

  Baseline thru Day 14

• Worsening of Disease

  Day 3 thru Day 14

• Return to Pre-COVID Health

  Days 8 and 14

Study Arms (3)

RD-X19 Device, Dose A

ACTIVE COMPARATOR

RD-X19. Investigational device that delivers 24 J/cm2 of electromagnetic energy to the oropharynx.

Device: RD-X19

RD-X19 Device, Dose B

ACTIVE COMPARATOR

RD-X19. Investigational device that delivers 32 J/cm2 of electromagnetic energy to the oropharynx.

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: Sham

Interventions

RD-X19 DEVICE

Investigational device that uses safe electromagnetic energy to target the oropharynx.

RD-X19 Device, Dose A; RD-X19 Device, Dose B

Sham DEVICE

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..

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 as detected using an FDA authorized SARS-CoV-2 antigen test at or within 24 hours of the screening visit.
• COVID-19 signs and symptoms within 72 hours from symptom onset, including at least two moderate\* or greater symptoms from: cough, sore throat, nasal congestion, headache, unexplained chills and/or sweats, myalgia, fatigue, nausea (with or without vomiting).
• o Alternatively, subjects with the presence of at least one moderate symptom and either a) a fever with an oral temperature of at least 100.5° F or b) shortness of breath/difficulty breathing on exertion (e.g., walking, going up and down stairs) are also eligible for enrollment.
• BMI \<40
• 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 saliva, nasopharyngeal, and venous blood specimens per protocol.
• Males or females, 18 to 65 years of age, inclusive.
• No uncontrolled disease process(es) based on patient reported medical history (chronic or acute), other than direct 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.
• Symptom scoring is independent from the classification of COVID-19 disease severity at baseline. Guidance to study subjects for grading of signs and symptoms will be based on definitions used for the grading of TEAEs:
• None (Grade 0): Not present
• Mild (Grade 1): Symptoms that are usually transient and may require only minimal or no palliative or specific therapeutic intervention and generally do not interfere with the subject's usual activities of daily living.
• Moderate (Grade 2): Symptoms that are usually alleviated with palliative or specific therapeutic intervention. The symptoms interfere with usual activities of daily living causing discomfort but pose no significant or permanent risk of harm to the study subject.
• Severe (Grade 3): Events interrupt usual activities of daily living, or significantly effect clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.

You may not qualify if:

• Positive urine pregnancy test at screening or females who intend to become pregnant during the study.
• COVID-19 signs associated with severe respiratory distress or imminent serious medical outcomes.\^\^
• \^\^Potential Study Subjects Presenting with any of the following should be referred for immediate medical care and are not eligible for the study
• Fever \> 104° F
• Cough with sputum production
• Rales and/or rhonchi
• Difficulty breathing with respiratory distress defined by a respiratory rate ≥30 per minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FiO2 \<300.
• Persistent pain or pressure in the chest
• Confusion
• Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
• Reports a recent positive test result (within the past 6 months) for hepatitis A, hepatitis B or, 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.
• Currently enrolled in or plans to participate in another clinical trial with a therapeutic investigational agent (e.g., monoclonal antibody, oral protease inhibitor) that will be received during the study period.
• History of systemic antiviral therapies (e.g., remdesivir) within the past 30 days.
• Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure.

Sponsors & Collaborators

• EmitBio Inc.: lead

Study Sites (9)

Site 2 - Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Site 1 - APF Research LLC

Miami, Florida, 33134, United States

Location

Site 8 - WellNow Urgent Care

Kalamazoo, Michigan, 49048, United States

Location

Site 9 - Revival Research Institute, LLC

Sterling Heights, Michigan, 48312, United States

Location

Site 4 - Peters Medical Research

High Point, North Carolina, 27260, United States

Location

Site 7 - WellNow Urgent Care

Cincinnati, Ohio, 45215, United States

Location

Site 5 - WellNow Urgent Care

Columbus, Ohio, 43214, United States

Location

Site 6 - WellNow Urgent Care

Dayton, Ohio, 45424, United States

Location

Site 3 - J&S Studies, Inc.

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 Medical Officer
• Organization: EmitBio Inc

info@emitbio.com

919.321.1734

Study Officials

• 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
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to the RD-X19 treatment arm or the sham treatment arm within each cohort in a 2:1 ratio according to a fixed schedule via a permuted block design.

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 19, 2021
• Study Start: June 17, 2021
• Primary Completion: January 5, 2022
• Study Completion: February 23, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)