What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral medications, monoclonal antibodies, and supportive therapies. Antiviral medications like remdesivir can cause side effects such as nausea, elevated liver enzymes, and potential kidney issues. Monoclonal antibodies may lead to infusion-related reactions, including fever, chills, and allergic reactions. Light-based therapies, like the EmitBio RD-X19 device, are generally considered safe but may cause mild skin irritation or eye discomfort. It is important to consult with a healthcare provider to understand the potential risks and benefits of each treatment option.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including antiviral drugs like remdesivir and monoclonal antibodies such as bamlanivimab and casirivimab/imdevimab. While light-based therapies like the EmitBio RD-X19 treatment device are still under investigation and not yet FDA-approved, phototherapy has shown potential in reducing viral load and inflammation in other contexts. Current FDA-approved treatments primarily focus on antiviral activity and immune modulation to manage COVID-19 symptoms and complications.

What other types of research exist?

Promising, novel alternatives to the EmitBio RD-X19 treatment device for Coronavirus patients in 2024 include monoclonal antibodies (e.g., bamlanivimab, casirivimab-imdevimab, sotrovimab), antiviral medications (e.g., nirmatrelvir-ritonavir), and immunomodulatory treatments (e.g., Itolizumab). These therapies have shown efficacy in reducing viral load and inflammation in clinical trials.

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Device

RD-X19 for COVID-19

N/A

Waitlist Available

Research Sponsored by EmitBio Inc.

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, day 5, day 8, and day 14 or early termination visit

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, day 5, day 8, and day 14 or early termination visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 5, day 8, and day 14 or early termination visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 5, day 8, and day 14 or early termination visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)

Number of Subjects With Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study)

Secondary study objectives

Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests

Number of Subjects With Two Negative SARS-CoV-2 Antigen Tests (With a Minimum Time Between Tests of Six Hours) Without Subsequent Virological Rebound During the Subject's Remaining Time on Study

Other study objectives

Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

RD-X19 Active Device Investigational device that uses 32 J/cm2 of 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.

Do I qualify?Apply below to find out

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.