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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07016321
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Dengue

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Emetine Hydrochloride 6mg — DRUG
    To administer Emetine Hydrochloride 6mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.
  • Placebo — DRUG
    Participant take a placebo for 10 consecutive days.
  • Emetine Hydrochloride 12mg — DRUG
    To administer Emetine Hydrochloride 12mg orally for 10 consecutive days to evaluate the efficacy and safety of emetine for symptomatic dengue patients.

Study Details

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.

Key Dates

First listed
Jun 11, 2025
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Mar 1, 2029
Completion
May 3, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Emetine 6 mg
    Participants take 6mg Emetine pill for 10 consecutive days
  • Active Comparator: Emetine 12 mg
    Participants take 12mg Emetine pill for 10 consecutive days
  • Placebo Comparator: Placebo
    Participant take a placebo for 10 consecutive days

Primary Outcome Measure

Evaluate effectiveness of emetine in dengue patients assessed by 28-day mortality or progression [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University, Division of Infectious DiseaseBaltimoreMaryland21231
Kunchok Dorjee, MBBS, PhD
[email protected]
410-502-7135
Kunchok Dorjee, MBBS, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins University, Division of Infectious Disease· Baltimore, MD

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