Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
NCT ID: NCT07016321
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
600 participants
INTERVENTIONAL
2025-12-01
2029-05-03
Brief Summary
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1. Does emetine reduce 28-day mortality or progression to severe dengue (severe plasma leakage, severe bleeding, or severe organ involvement)?
2. What are the safety outcomes of emetine, including serious adverse events and toxicities?
Participants will be asked to:
1. Take either 6mg emetine, 12mg emetine, or a placebo pill for 7 consecutive days as part of the treatment regimen.
2. Have blood samples taken for at least 5 days to monitor viral load, inflammatory markers, and safety parameters.
3. Be monitored by healthcare staff for daily vital signs and symptoms for clinical assessments for 28 days.
Detailed Description
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In vitro and in vivo studies have suggested strong antiviral activity of emetine against SARS-CoV-2, dengue, Ebola, cytomegalovirus, and several other viruses. Low et al. had carefully demonstrated that emetine inhibited all four serotypes of DENV infection in cell lines by inhibiting the viral RNA synthesis or the viral protein translation pathway. In the past, emetine, an alkaloid extracted from ipecacuanha roots, has been widely used in the human treatment of amoebic dysentery, amoebic liver abscess, and several viruses such as herpes simplex, herpes zoster, influenza, hepatitis, and mumps. Because of cardiotoxicity (cardiac dysrhythmias), emetine was replaced by metronidazole. The toxicity was unequivocally associated with high-dose emetine (60 mg/day for 10 days to achieve an minimum inhibitory concentration (MIC) of 25 micromol (µM) against Entamoeba histolytica; however, the cardiovascular side-effects were minimal or none when emetine was used for various indications in low dose (\<20 mg/day). The investigators have recently shown that by lowering the standard amoebicidal dose by a factor of 10, emetine can inhibit viral replication while avoiding cardiovascular toxicity.
Phase 1 and 2 studies have been previously carried out. The investigators' clinical trial to evaluate emetine against SARS-CoV-2 is currently approved by Johns Hopkins Medicine (JHM) Institutional Review Board (IRB) (IRB00283778) and is ongoing in Nepal. The investigators have enrolled a few patients in this trial and have not encountered any toxicity. Given the broad-spectrum antiviral activity of emetine, the investigators now plan to evaluate emetine's efficacy and safety in the treatment of symptomatic dengue fever in a clinical trial. The investigators hypothesize that emetine will be efficacious against dengue at low doses. By evaluating its efficacy against dengue, this research can directly inform treatment strategies for patients in over 100 countries, since about 50% of the global population is at risk of dengue fever. In the past, emetine was an essential World Health Organization (WHO)- and FDA-approved drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Emetine 6 mg
Participants take 6mg Emetine pill for 10 consecutive days
Emetine Hydrochloride 6mg
To administer Emetine Hydrochloride 6mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.
Emetine 12 mg
Participants take 12mg Emetine pill for 10 consecutive days
Emetine Hydrochloride 12mg
To administer Emetine Hydrochloride 12mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.
Placebo
Participant take a placebo for 10 consecutive days
Placebo
Participant take a placebo for 10 consecutive days.
Interventions
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Emetine Hydrochloride 6mg
To administer Emetine Hydrochloride 6mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.
Placebo
Participant take a placebo for 10 consecutive days.
Emetine Hydrochloride 12mg
To administer Emetine Hydrochloride 12mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.
Eligibility Criteria
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Inclusion Criteria
2. Admitted to the hospital
3. Laboratory-confirmed infection with dengue virus within the last 5 days and preferably within the last 3 days. Testing for dengue virus using positive Nonstructural protein 1(NS1) strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR)
4. Having two or more clinical symptoms (fever, headache, retro-orbital pain, myalgia, arthralgia, rash, hemorrhagic manifestations, or leucopenia, gastrointestinal symptoms) with the onset of fever within 72 hours of presentation, and
5. Able to provide voluntary informed consent and comply with all study procedures and visits.
Exclusion Criteria
2. Pregnant or breastfeeding
3. Current or recent use of the study drug
4. Known allergy to study drug
5. Current or planned participation in another pharmacological interventional trial in the next 10 days
6. Participants with known past history of dengue infection
7. Participants on aspirin, anticoagulants, or with other conditions that might increase the risk of bleeding
8. Participants on immunosuppressive agents, including long-term steroids
9. Severe dengue as defined by the WHO 2009 revised case classification.
10. Individuals with long-term immunosuppressive agents such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or those on systemic corticosteroid therapy
11. History of prior vaccination against dengue fever within one year.
12. Patients who have recently used ayurvedic or herbal medications for dengue or any other conditions in the last 7 days (eg, Papaya leaf extract)
18 Years
65 Years
ALL
No
Sponsors
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Bharatpur Hospital Chitwan
UNKNOWN
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Kunchok Dorjee, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University, Division of Infectious Disease
Baltimore, Maryland, United States
Bharatpur Hospital
Bharatpur-10, Chitwan, Nepal
Countries
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Central Contacts
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Facility Contacts
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Kunchok Dorjee, MBBS, PhD
Role: primary
Kalyan Sapkota, MD
Role: primary
References
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Choy KT, Wong AY, Kaewpreedee P, Sia SF, Chen D, Hui KPY, Chu DKW, Chan MCW, Cheung PP, Huang X, Peiris M, Yen HL. Remdesivir, lopinavir, emetine, and homoharringtonine inhibit SARS-CoV-2 replication in vitro. Antiviral Res. 2020 Jun;178:104786. doi: 10.1016/j.antiviral.2020.104786. Epub 2020 Apr 3.
Ooi EE. Repurposing Ivermectin as an Anti-dengue Drug. Clin Infect Dis. 2021 May 18;72(10):e594-e595. doi: 10.1093/cid/ciaa1341. No abstract available.
Bhat CS, Shetty R, Sundaram B, Ramanan AV. Immunomodulatory therapy in dengue: need for clinical trials and evidence base. Arch Dis Child. 2023 Jun;108(6):451-452. doi: 10.1136/archdischild-2022-324100. Epub 2022 Jun 9. No abstract available.
Guzman MG, Gubler DJ, Izquierdo A, Martinez E, Halstead SB. Dengue infection. Nat Rev Dis Primers. 2016 Aug 18;2:16055. doi: 10.1038/nrdp.2016.55.
Beesetti H, Khanna N, Swaminathan S. Investigational drugs in early development for treating dengue infection. Expert Opin Investig Drugs. 2016 Sep;25(9):1059-69. doi: 10.1080/13543784.2016.1201063. Epub 2016 Jun 24.
Entner N, Grollman AP. Inhibition of protein synthesis: a mechanism of amebicide action of emetine and other structurally related compounds. J Protozool. 1973 Feb;20(1):160-3. doi: 10.1111/j.1550-7408.1973.tb06025.x. No abstract available.
Bleasel MD, Peterson GM. Emetine Is Not Ipecac: Considerations for Its Use as Treatment for SARS-CoV2. Pharmaceuticals (Basel). 2020 Nov 27;13(12):428. doi: 10.3390/ph13120428.
Grollman AP. Structural basis for inhibition of protein synthesis by emetine and cycloheximide based on an analogy between ipecac alkaloids and glutarimide antibiotics. Proc Natl Acad Sci U S A. 1966 Dec;56(6):1867-74. doi: 10.1073/pnas.56.6.1867. No abstract available.
Other Identifiers
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IRB00486563
Identifier Type: -
Identifier Source: org_study_id