EC-18 for COVID-19 Pneumonia

Not yet recruiting at 2 trial locations
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JC
DK
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Overseen ByTed Kim, M.B.A.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Enzychem Lifesciences Corporation
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EC-18 to determine if it can help people with mild or moderate pneumonia caused by COVID-19. The goal is to see if EC-18 can prevent the illness from worsening into severe pneumonia or acute respiratory distress syndrome (ARDS). Participants will receive either EC-18 or a placebo (a harmless pill with no active ingredients) to compare effects. This trial suits those diagnosed with pneumonia due to COVID-19 who do not require significant oxygen support or have severe respiratory issues. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Without clear safety data from other studies, consider the phase of this trial. This trial is in Phase 2, indicating that EC-18 has undergone basic safety testing in humans in earlier studies. In Phase 2, researchers closely monitor how well participants tolerate the treatment and observe any side effects. Reaching this phase suggests that EC-18 is likely considered reasonably safe. However, specific details about side effects or safety are not provided here. Always discuss any questions or concerns about joining a trial with your healthcare provider.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for COVID-19, which often focus on reducing symptoms or preventing virus replication, EC-18 is unique because it targets the body's immune response to prevent progression to severe pneumonia or ARDS. Researchers are excited about EC-18 because it has a novel mechanism of action that modulates the immune system, potentially reducing inflammation that leads to severe respiratory issues. This could provide a new way to protect patients from developing severe complications, offering hope for more effective management of COVID-19.

What evidence suggests that EC-18 might be an effective treatment for pneumonia due to COVID-19?

This trial will compare the investigational treatment EC-18 with a placebo. Studies suggest that EC-18 may help reduce inflammation and has been tested for various conditions, such as atopic dermatitis. However, limited direct evidence exists on its effectiveness for COVID-19 pneumonia. Researchers hope that EC-18 might control the body's reaction to COVID-19 by reducing inflammation, which can lead to severe pneumonia or breathing problems. Early research appears promising, but more information is needed to confirm its effectiveness specifically for COVID-19 pneumonia.678910

Are You a Good Fit for This Trial?

This trial is for people with mild or moderate COVID-19 pneumonia confirmed by a test and chest scan, who can swallow medicine and do not need high levels of oxygen or a ventilator. Participants must be hospitalized or about to be, and willing to give consent.

Inclusion Criteria

RT-PCR or Abbott ID Now COVID-19 test
Those who are planned to be hospitalized or who are just hospitalized
Chest X-ray or computed tomography (CT) scan (findings of the increased opacity on a chest X-ray, ground-glass opacity indicative of pneumonia on CT, opinion on consolidation, etc.)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive EC-18 or placebo for the prevention of progression to severe pneumonia or ARDS

4 weeks
Daily monitoring for 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EC-18
  • Placebo

Trial Overview

The study compares EC-18 (an experimental drug) against a placebo in patients with mild/moderate COVID-19 pneumonia. Patients are randomly assigned to receive either EC-18 or the placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active EC-18Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enzychem Lifesciences Corporation

Lead Sponsor

Trials
8
Recruited
540+

Citations

Study Details | NCT06487000 | Determine the Dose ...

To evaluate the efficacy and safety of oral administration of dose-dependent EC-18 for 16 weeks in patients with moderate to severe atopic dermatitis

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