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
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
-
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
-
Bharatpur Hospital Chitwan
collaborator UNKNOWN - lead OTHER
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
-
Evaluation of the Safety and Efficacy of a Single Dose of a Dengue Vaccine (TV005) in Healthy Adults
NCT02317900 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30
NCT02873260 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge
NCT03416036 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Safety and Immune Response of Five Admixtures of a Tetravalent Dengue Virus Vaccine
NCT01072786 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Clinical and Immune Response to Two Dengue Virus Vaccines in Healthy Adults
NCT02392325 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
NCT02433652 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response of a 2-dose Regimen of rDEN1delta30 Dengue Virus Vaccine
NCT00473135 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN2/4delta30[ME]) in Healthy Adults
NCT00094705 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine
NCT01506570 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
NCT02684383 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to DEN4 Vaccine Component Candidate for Dengue Virus
NCT00919178 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-200,201) in Healthy Adults
NCT00270699 ·Status: COMPLETED ·Phase: PHASE1
-
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults
NCT01666652 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults
NCT00350337 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age
NCT02879266 ·Status: COMPLETED ·Phase: PHASE1
-
TDENV PIV and LAV Dengue Prime-boost Strategy Using AS03B Adjuvant
NCT03110952 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study of HBV-001 D1 in Healthy Adults
NCT00936429 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
NCT00290147 ·Status: COMPLETED ·Phase: PHASE1
-
IC14 in Adult Patients With Dengue Fever
NCT03875560 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
NCT00920517 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
NCT01084291 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Immune Response to Two Doses of a Dengue Virus Vaccine Administered 12 Months Apart
NCT01782300 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults
NCT00322946 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)
NCT02450838 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh
NCT02678455 ·Status: COMPLETED ·Phase: PHASE2