A Phase 2/3 interventional study of Emetine Hydrochloride 6mg and Placebo in Dengue, sponsored by Johns Hopkins University. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Johns Hopkins University · Phase 2/3, Interventional, and Treatment
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 dengue virus. The main questions it aims to answer are:
Participants will be asked to:
Dengue fever is a mosquito-borne viral infection caused by the dengue virus (DENV), which belongs to the Flaviviridae family. It is transmitted primarily by Aedes aegypti and Aedes albopictus mosquitoes. Dengue is recognized as one of the top ten global public health threats, affecting an estimated 390 million people annually, with approximately 96 million cases manifesting clinically. Globally, dengue has seen a significant rise in incidence, with a 30-fold increase in the past 50 years. There is currently no antiviral agent proven to work against it. Dengue fever is endemic in Nepal with cyclical outbreaks. The country relies on supportive treatment. This often includes intravenous fluids and, in rare cases, steroids and organ support. Effective antiviral agents could significantly reduce the burden of dengue by preventing disease progression and reducing transmission.
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.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 600 is above the median of 132 across 197 interventional studies indexed under Dengue.
Browse Dengue studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants take 6mg Emetine pill for 10 consecutive days
Drug: Emetine Hydrochloride 6mg
Participants take 12mg Emetine pill for 10 consecutive days
Drug: Emetine Hydrochloride 12mg
Participant take a placebo for 10 consecutive days
Drug: Placebo
To administer Emetine Hydrochloride 6mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.
Participant take a placebo for 10 consecutive days.
To administer Emetine Hydrochloride 12mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.
Evaluate effectiveness of emetine in dengue patients assessed by 28-day mortality or progression
28-day mortality or progression to severe dengue, defined as severe plasma leakage, severe bleeding, or severe organ involvement (death and severe dengue will be assessed as a composite outcome)
Time frame: 28 days
Safety of emetine assessed by number of adverse events
Record serious adverse events and toxicities by organ-system
Time frame: Up to 28 days
Safety of emetine assessed by rate of drug discontinuation
Evaluate the safety of emetine assessed by rate of drug discontinuation
Time frame: Up to 28 days
Recovery (≥ 3 days without symptoms)
Sustained resolution of all dengue symptoms for ≥ 3 consecutive days (where the first of those days is considered the date of recovery)
Time frame: Up to 14 days
Time to Virologic Clearance of Dengue Virus by Qualitative RT-PCR
Time to test negativity that is longitudinally measured by Qualitative real-time polymerase chain reaction (RT-PCR).
Time frame: Pre-dose (day 0), day 3, and day 5
Quantitative Viral Load Assessment by RT-PCR Cycle Threshold (Ct) Values
Measures of the average RT-PCR cycle threshold (Ct) values for dengue virus RNA at specified time points post-randomization.
Time frame: Days 0,3, 5
Changes in inflammatory marker measured by hematocrit
Measure hematocrit in percentage (%) for patients
Time frame: Days 0 to 5
Changes in inflammatory marker measured by white blood count
Measure white blood count (WBC) for patients measured per microliter (mcL)
Time frame: Day 0-5
Changes in inflammatory marker measured by reticulocyte count
Measure reticulocyte count as percentage (%) for patients
Time frame: Day 0-5
Changes in inflammatory marker measured by platelet count
Measure platelet count for patients measured per microliter (mcL)
Time frame: Day 0-5
Changes in inflammatory marker measured by alanine aminotransferase
Measure alanine aminotransferase (ALT) for patients in units per liter (U/L)
Time frame: Day 0-5
Changes in inflammatory marker measured by serum bilirubin
Measure serum bilirubin for patients in milligrams per deciliter (mg/dL)
Time frame: Day 0-5
Changes in inflammatory marker measured by serum albumin
Measure serum albumin for patients in grams per deciliter (g/dL)
Time frame: Day 0-5
Changes in inflammatory marker measured by C-reactive protein
Measure C-reactive protein (CRP) for patients in milligrams per liter (mg/L)
Time frame: Day 0-5
Post infection fatigue measured by Fatigue Questionnaire
Fatigue will be measured using the validated 11-item Fatigue Questionnaire (FQ), which assesses both physical (7 items) and mental (4 items) fatigue. Each item is rated on a 4-point Likert scale (0 = none, 3 = severe), with total scores ranging from 0 to 33, where higher scores indicate greater fatigue severity.
Time frame: On Day 28
Started Sep 2026 (actual). Primary completion is estimated for Mar 2029, 30 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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