Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
ConditionDengue
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University
About this trial
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:
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.
Eligibility criteria
Qualifiers
Age 18 to 65 years
Admitted to the hospital
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)
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
Disqualifiers
Age ≥65 years
Pregnant or breastfeeding
Current or recent use of the study drug
Known allergy to study drug
Trial design
Treatments tested in this trial
- Emetine Hydrochloride 6mg
- Placebo
- Emetine Hydrochloride 12mg
Treatment groups
600 Participants
are divided into 3 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Bharatpur Hospital Chitwan
Collaborator
Source ClinicalTrials.gov