Emetine for COVID-19

(EVOLVE Trial)

Recruiting at 2 trial locations

Overseen By Kunchok Dorjee, MBBS, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Johns Hopkins University

Disqualifiers: Asymptomatic, Pregnant, Cardiac disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 10 days

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether orally taken emetine can ease Covid-19 symptoms. Researchers aim to determine if it is more effective than a placebo (a pill with no active medicine). The trial targets individuals who have recently tested positive for Covid-19 and are experiencing symptoms such as cough, fever, or fatigue. Participants will take emetine for 10 days and will be monitored for any changes in their symptoms. This trial is specifically for those aged 30 or older who are not experiencing severe Covid-19 that requires intensive care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment.

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.

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

Research has shown that emetine has been studied for its ability to fight viruses like COVID-19 without causing drug-resistant strains. In previous studies, patients took emetine for 10 days to assess its effectiveness and safety. While specific side effects are not detailed, the treatment has reached advanced trial stages, suggesting it demonstrated some safety in earlier studies. Researchers are testing emetine to determine if it can safely alleviate COVID-19 symptoms. Participants in the trial will have their health closely monitored to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Unlike standard treatments for COVID-19, which often include antivirals like Remdesivir or monoclonal antibodies, Emetine is derived from a plant-based compound known for its historical use in treating amoebic infections. Researchers are excited about Emetine because it has shown potential to disrupt viral replication processes. This unique mechanism of action could offer a new way to combat the virus, especially as it addresses viral replication directly. Additionally, Emetine's ability to act quickly might lead to faster symptom relief, potentially reducing the duration and severity of the illness.

What evidence suggests that emetine might be an effective treatment for COVID-19?

Research has shown that emetine can help stop the virus that causes COVID-19 from multiplying. One study found that emetine was 30 times more effective at stopping the virus in lab-grown cells than some other treatments. At low doses, emetine also showed promise in treating COVID-19 and other viral infections in animal studies. This trial will compare emetine with a placebo to evaluate its effectiveness in reducing symptoms in COVID-19 patients. However, more research is needed to confirm these effects in humans. ^{1 2 3 5 6}

Who Is on the Research Team?

Kunchok Dorjee, MBBS, PhD, MPH

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Emetine Hydrochloride
• Placebo

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.

How Is the Trial Designed?

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 United States, Canada for the following indications:

Approved in United States as Emetine for:

• Amebiasis

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+

Nepal Health Research Council

Collaborator

Trials

17

Recruited

6,700+

Stony Brook University

Collaborator

Trials

225

Recruited

41,700+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Bharatpur Hospital Chitwan

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05889793

Evaluating Emetine for Viral Outbreaks (EVOLVE) To administer Emetine Hydrochloride 6mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic Covid-19 patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9159504/

Different Aspects of Emetine's Capabilities as a Highly Potent ... The results of this study showed that emetine could effectively suppress SARS-CoV-2 replication in Vero cells, with EC50 = 0.007 μM (30-fold more effective ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772417424000451

Therapeutic potential of natural alkaloid emetine against ... At low doses, emetine is effective for treatment of COVID-19 patients and other viral infections in rodents. This review discusses the current findings on the ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/448044

Evaluating Emetine for Viral Outbreaks (EVOLVE) To administer Emetine Hydrochloride 6mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic Covid-19 patients.

5. reaganudall.org reaganudall.org/clinical-trial/evaluating-emetine-viral-outbreaks-evolve

Evaluating Emetine for Viral Outbreaks (EVOLVE) The goal of this clinical trial (phase 2/phase 3) is to evaluate the efficacy and safetyof emetine administered orally for symptomatic Covid-19 patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07016321

Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral ... The goal of this study is to evaluate the efficacy and safety of emetine administered orally for symptomatic patients aged 18-65 years infected with the ...