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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
Study Summary
This trial tests a COVID-19 treatment device to see if it's safe & effective in people 40+ with mild symptoms at home.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sustained resolution of COVID-19 signs and symptoms
Secondary outcome measures
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.
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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
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process for this research project still open?
"This medical research, which was first shared on April 21st 2023, is currently searching for participants. Recent edits to the trial were made on April 14th 2023 according to clinicaltrials.gov."
Answered by AI
What is the total number of enrollees in this research project?
"Affirmative. The official data hosted on clinicaltrials.gov reveals that this medical trial is actively seeking candidates, which was initially posted online on April 21st 2023 and recently updated in April 14th 2023. A total of 326 individuals are required from a single site for the study to reach completion."
Answered by AI
Who else is applying?
What site did they apply to?
315 - Revival Research Institute - Dearborn
What portion of applicants met pre-screening criteria?
Did not meet criteria
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