Emetine for COVID-19

(EVOLVE Trial)

Recruiting at2 trial locations

Overseen by Kunchok Dorjee, MBBS, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Asymptomatic, Pregnant, Cardiac disease, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial (phase 2/phase 3) is to evaluate the efficacy and safety of emetine administered orally for symptomatic Covid-19 patients in patients ages 30 years and above. Participants will be asked to: * Take Emetine 6mg orally for 10 consecutive days * Be monitored by healthcare staff or self-monitor for daily vital signs and symptoms * Undergo blood draws Researchers will compare the control group given placebo medicine to assess if emetine improved the symptoms of Covid-19.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug emetine differ from other COVID-19 treatments?

Emetine is unique because it is an old drug with potent antiviral and anti-inflammatory properties, originally used for amoebiasis, and it accumulates in high concentrations in the lungs, making it potentially effective against COVID-19. It works by inhibiting both virus and host targets, and it can reduce inflammation and complications like pulmonary arterial hypertension, but it must be used carefully due to potential cardiotoxic effects. ^{1 2 3 4 5}

Research Team

Kunchok Dorjee, MBBS, PhD, MPH

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for people over 30 with symptomatic COVID-19 confirmed by RT-PCR within the last 10 days. Participants must have had symptoms like cough, fever, or sore throat in the past week and be able to consent. It's not for asymptomatic patients, those in other trials, critically ill patients, pregnant women, or those with heart disease.

Inclusion Criteria

You tested positive for COVID-19 using a specific test within 10 days before the screening visit.

I have COVID-19 symptoms like cough, fever, or sore throat, confirmed by a test.

Ability to give informed consent (administered in local language)

Exclusion Criteria

I require a breathing tube, mechanical breathing support, or intensive care.

I am critically ill with COVID-19.

Known allergy to study drug

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Emetine 6mg orally for 10 consecutive days and are monitored for vital signs and symptoms

10 days

Daily monitoring (self or healthcare staff)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of health-related quality of life

180 days

Visits at days 30, 90, and 180

Treatment Details

Interventions

• Emetine Hydrochloride (Other)
• Placebo (Other)

Trial Overview The EVOLVE trial is testing if Emetine Hydrochloride (6mg taken orally for 10 days) can improve COVID-19 symptoms compared to a placebo. Patients will self-monitor or be monitored daily and undergo blood tests to track their progress.

Participant Groups

Group I: Emetine Active Control 1 Intervention

Participant takes Emetine 6mg for 10 consecutive days

Group II: Placebo Placebo Group 1 Intervention

Participant takes a placebo for 10 consecutive days

Emetine Hydrochloride is already approved in Canada for the following indications:

Approved in Canada as Emetine for:

• Amebiasis

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Nepal Health Research Council

Collaborator

Trials

17

Recruited

6,700+

Stony Brook University

Collaborator

Trials

225

Recruited

41,700+

Dr. James A. Hayward

Stony Brook University

Chief Executive Officer since 1990

PhD in Molecular Biology from the State University of New York at Stony Brook

Dr. Louis A. Peña

Stony Brook University

Chief Medical Officer since 2023

MD from Harvard Medical School

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Dr. Carolyn Seyss

Rutgers University

Chief Medical Officer since 2023

PharmD

Dr. Joseph A. Barone

Rutgers University

Chief Executive Officer since 2016

PharmD, FCCP

Bharatpur Hospital Chitwan

Collaborator

Trials

1

Recruited

600+

Findings from Research

Emetine has been identified as a potent anti-SARS-CoV-2 compound with sub-micromolar effectiveness, showing both antiviral properties and the ability to reduce inflammation in COVID-19 patients by inhibiting NF-κB.

While emetine demonstrates significant therapeutic potential, including reducing pulmonary arterial hypertension, its cardiotoxic effects at high doses pose safety concerns, suggesting a need for the development of less toxic derivatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Aspects of Emetine's Capabilities as a Highly Potent SARS-CoV-2 Inhibitor against COVID-19. Valipour, M.[2023]

Emetine has demonstrated potent antiviral activity against various viruses, including a potential effective dose for SARS-CoV-2 that is significantly lower than the dose used for treating amoebiasis, which may reduce the risk of side effects.

Historically, emetine showed rapid improvement in symptoms for patients with Spanish influenza, primarily due to its anti-inflammatory properties rather than direct antiviral effects, suggesting its mechanism of action may be beneficial in treating viral infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emetine Is Not Ipecac: Considerations for Its Use as Treatment for SARS-CoV2. Bleasel, MD., Peterson, GM.[2020]

In a study involving 63 patients with mild COVID-19, low-dose emetine was found to improve clinical symptoms without significant adverse effects, suggesting its potential as a treatment option.

The treatment group showed better oxygen saturation levels compared to the control group, indicating that emetine may enhance respiratory function in COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of low-dose emetine for patients with COVID-19: a real-world study. Fan, S., Zhen, Q., Chen, C., et al.[2022]

Emetine, an old drug previously used to treat amoebiasis, shows promise as a potential treatment for COVID-19 due to its low effective concentration against coronaviruses and its ability to reach much higher concentrations in the lungs compared to the blood.

The study suggests that emetine could be more effective against coronaviruses than against the amoeba it was originally designed to treat, and it discusses how to manage its known side effects and the best ways to administer it for COVID-19 treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emetine, Ipecac, Ipecac Alkaloids and Analogues as Potential Antiviral Agents for Coronaviruses. Bleasel, MD., Peterson, GM.[2020]

In vitro studies showed that emetine was the most effective compound against SARS-CoV-2, with a 50% effective concentration of only 0.46 μM, while remdesivir and lopinavir also demonstrated antiviral effects at higher concentrations.

Combining remdesivir with emetine resulted in a synergistic effect, potentially allowing for lower doses of each drug to achieve significant inhibition of the virus, which could enhance clinical outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remdesivir, lopinavir, emetine, and homoharringtonine inhibit SARS-CoV-2 replication in vitro. Choy, KT., Wong, AY., Kaewpreedee, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Different Aspects of Emetine's Capabilities as a Highly Potent SARS-CoV-2 Inhibitor against COVID-19. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Emetine Is Not Ipecac: Considerations for Its Use as Treatment for SARS-CoV2. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy of low-dose emetine for patients with COVID-19: a real-world study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Emetine, Ipecac, Ipecac Alkaloids and Analogues as Potential Antiviral Agents for Coronaviruses. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Remdesivir, lopinavir, emetine, and homoharringtonine inhibit SARS-CoV-2 replication in vitro. [2022]