Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)

NCT07016321 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-12-12

No results posted yet for this study

Summary

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.

Conditions

  • Dengue

Interventions

DRUG

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.

DRUG

Placebo

Participant take a placebo for 10 consecutive days.

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Kunchok Dorjee, MBBS, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-03-01
Completion
2029-05-03
FDA Drug
Yes

Countries

  • United States
  • Nepal

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016321 on ClinicalTrials.gov