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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 14
Awards & highlights
Summary
This trial tests the EmitBio RD-X19, a home-use device for treating mild COVID-19 in people aged 40 and older. The device may use light or energy to reduce symptoms. EmitBio RD-X19 is being tested for its ability to inactivate the virus causing COVID-19, using light-based technology. The study aims to determine if the device is safe and effective.
Who is the study for?
This trial is for adults aged 40 and over with mild COVID-19, a BMI under 40, and symptoms that started within the last 72 hours. Participants must test positive for SARS-CoV-2 but negative for influenza A/B. They should have at least two moderate COVID-19 symptoms or one symptom plus fever. Pregnant women can join. Exclusions include certain oral conditions, recent use of asthma inhalers or antiviral therapies, severe allergies to sun exposure, and other specific health issues.
What is being tested?
The study tests the RD-X19 treatment device against a sham (fake) device in people with mild COVID-19 at home. It's randomized (participants are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), and aims to see how effective and safe the RD-X19 is.
What are the potential side effects?
Since this trial involves a non-pharmaceutical device, typical drug side effects may not apply; however, potential risks could include discomfort from using the device or an allergic reaction to its materials.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sustained resolution of COVID-19 signs and symptoms
Secondary study objectives
Time to first of two consecutive negative antigen tests
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
RD-X19 Active Device
Investigational device that uses safe electromagnetic energy to target the oropharynx.
Group II: ShamPlacebo Group1 Intervention
RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for COVID-19 include antiviral medications, monoclonal antibodies, and anti-inflammatory drugs. Antivirals like remdesivir inhibit viral replication, while monoclonal antibodies target the virus to prevent it from entering cells.
Anti-inflammatory drugs, such as dexamethasone, reduce the immune system's overreaction, known as a cytokine storm. Light-based therapies, like the EmitBio RD-X19 device, aim to reduce viral load and inflammation through photobiomodulation, which can enhance cellular repair and reduce oxidative stress.
Understanding these mechanisms helps tailor treatments to reduce viral replication, mitigate severe immune responses, and improve patient outcomes.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.Drugs against SARS-CoV-2: What do we know about their mode of action?A large-scale transcriptional study reveals inhibition of COVID-19 related cytokine storm by traditional Chinese medicines.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.Drugs against SARS-CoV-2: What do we know about their mode of action?A large-scale transcriptional study reveals inhibition of COVID-19 related cytokine storm by traditional Chinese medicines.
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Who is running the clinical trial?
EmitBio Inc.Lead Sponsor
3 Previous Clinical Trials
288 Total Patients Enrolled
Study Director EB-P30-01Study DirectorEmitBio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to take strong painkillers for my pain.I have had COVID-19 symptoms for more than 72 hours.I have used an FDA-approved COVID-19 treatment within the last month.I do not have any mouth problems that would affect using a medical device.I am 40 years or older.I have used a rescue inhaler for my asthma in the last month.I have not taken any corticosteroids in the last month.I am younger than 40 years old.I haven't taken antiviral medications in the last month.I do not have any health conditions that would prevent me from joining the study.I tested positive for COVID-19 with an FDA-approved test.I don't have any uncontrolled health conditions except for COVID-19.I have moderate to severe COVID-19 symptoms affecting my lungs.I have at least two moderate COVID-19 symptoms or one with fever.I agree to limit and report any COVID-19 symptom relief medications I use during the study.I agree not to use specific oral and nasal products during the study.I cannot remove my metal oral piercings for the study.I agree to a nose swab test to check for viruses and their genetic material.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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