Emetine for Dengue Fever

Not yet recruiting at 1 trial location

Overseen By Kunchok Dorjee, MBBS, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Johns Hopkins University

Must not be taking: Aspirin, Anticoagulants, Immunosuppressants, others

Disqualifiers: Age ≥65, Pregnant, Severe dengue, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called emetine, an experimental drug, for people with dengue fever, a viral illness causing symptoms like fever, headache, and muscle pain. The research aims to determine if emetine can reduce disease severity or lower the risk of death over 28 days. Participants will receive different doses of emetine or a placebo, a harmless pill with no effect, and their health will be closely monitored. Suitable candidates for this trial have confirmed dengue virus infection, are hospitalized, and exhibit symptoms like fever and headache. As a Phase 2 trial, this research measures how well emetine works in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking aspirin, anticoagulants, immunosuppressive agents, and ayurvedic or herbal medications like Papaya leaf extract. If you're on these medications, you may need to stop them to participate.

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

Research has shown that emetine, when injected, can cause side effects such as nausea and vomiting. However, limited information exists about its safety when taken as a pill, which is the method being tested in this trial for dengue fever.

In the past, emetine has caused side effects, particularly nausea, prompting doctors to carefully control the dosage. The trial is testing two doses, 6 mg and 12 mg, to assess their safety in pill form. Since the trial is in later stages, emetine has already passed some safety checks. However, because it is not fully approved for use as a pill against dengue, ongoing studies are crucial to confirm its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dengue fever?

Unlike the standard dengue fever treatments, which typically focus on symptom management and supportive care, Emetine offers a new approach by directly targeting the virus. Emetine is an active compound known for its antiviral properties, which sets it apart from the usual treatments that don't address the virus itself. Researchers are excited about Emetine because it could potentially shorten the duration of the illness and reduce the severity of symptoms, providing a more effective solution for dengue fever patients.

What evidence suggests that emetine might be an effective treatment for dengue fever?

Research has shown that emetine has strong antiviral effects against several viruses, including dengue. Studies indicate that emetine can stop the dengue virus from multiplying by preventing it from making its genetic material. In past research, emetine quickly improved symptoms like bluish skin due to low oxygen levels within 12–24 hours. The treatment also reduces inflammation, which could help with dengue symptoms. This trial will evaluate different dosages of emetine, with participants receiving either 6 mg or 12 mg doses, or a placebo. These findings suggest that emetine might effectively reduce the effects of the dengue virus and its related symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Kunchok Dorjee, MBBS, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with dengue fever. Participants must take a pill for 7 days and have blood tests for at least 5 days. They'll be monitored daily for 28 days. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am between 18 and 65 years old.

Admitted to the hospital

Laboratory-confirmed infection with dengue virus within the last 5 days and preferably within the last 3 days using positive Nonstructural protein 1(NS1) strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR)

Exclusion Criteria

I have been vaccinated against dengue fever in the last year.

I have not used any herbal or ayurvedic medications in the last week.

I have had dengue fever in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take either 6mg emetine, 12mg emetine, or a placebo pill for 7 consecutive days

1 week

Daily monitoring for 7 days

Monitoring

Participants have blood samples taken for at least 5 days to monitor viral load, inflammatory markers, and safety parameters

5 days

Daily visits for blood sampling

Follow-up

Participants are monitored by healthcare staff for daily vital signs and symptoms for clinical assessments

28 days

Regular monitoring visits

What Are the Treatments Tested in This Trial?

Interventions

• Emetine

Trial Overview The EVOLVE study is testing the effectiveness of emetine, an oral medication, in reducing death or progression to severe dengue compared to a placebo. Patients will receive either a low dose (6mg), high dose (12mg) of emetine, or a placebo.

How Is the Trial Designed?

Group I: Emetine 12 mg Active Control 1 Intervention

Participants take 12mg Emetine pill for 10 consecutive days

Group II: Emetine 6 mg Active Control 1 Intervention

Participants take 6mg Emetine pill for 10 consecutive days

Group III: Placebo Placebo Group 1 Intervention

Participant take a placebo for 10 consecutive days

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Bharatpur Hospital Chitwan

Collaborator

Trials

1

Recruited

600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07016321

Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral ... In vitro and in vivo studies have suggested strong antiviral activity of emetine against SARS-CoV-2, dengue, Ebola, cytomegalovirus, and several other viruses.

2. withpower.com withpower.com/trial/phase-2-and-3-dengue-8-2025-4c6d5

Emetine for Dengue Fever · Info for Participants 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 ...

3. researchgate.net researchgate.net/publication/45387067_Antiviral_Activity_of_Emetine_Dihydrochloride_Against_Dengue_Virus_Infection

(PDF) Antiviral Activity of Emetine Dihydrochloride Against ... Emetine was also shown to inhibit DENV replication consistently in all the dengue serotypes. Experiments were designed to define the stage of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7760625/

Emetine Is Not Ipecac: Considerations for Its Use as Treatment ... Emetine rapidly reversed the cyanosis and other symptoms of this disease in 12–24 h. However, emetine also has been shown to have anti-inflammatory properties ...

5. semanticscholar.org semanticscholar.org/paper/Antiviral-Activity-of-Emetine-Dihydrochloride-Virus-Low-Chen/11a6c4113b436d52f2349e6b86d29c501ac69d10

Antiviral Activity of Emetine Dihydrochloride Against ... Emetine can inhibit DENV infection by impeding viral RNA synthesis therefore emetine could be further assessed and developed as a potential antiviral ...

6. sigmaaldrich.com sigmaaldrich.com/US/en/product/sigma/e2375?srsltid=AfmBOoopZ5_WtzQ0Va55ri2oVwmNiNGNZPxBEkCVy9VeoUny00O2fmUQ

Emetine 7083-71-8 Emetine dihydrochloride has been used: as a protein synthesis inhibitor to study its effects on human papillomavirus type 8 E2 protein half-life[1] ...

7. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/emetine

Emetine - an overview Emetine is usually administered s.c. or i.m. It is not given orally as it frequently produces nausea and vomiting when given that way. Toxicity is limiting in ...