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

RecruitingPhase 2, Phase 3

Sponsor: Johns Hopkins University

Conditions: Dengue

Interventions: Emetine Hydrochloride 6mg, Placebo, Emetine Hydrochloride 12mg

Countries: United States, Nepal

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 65 years
2. Admitted to the hospital
3. 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)
4. 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
5. Able to provide voluntary informed consent and comply with all study procedures and visits.

Exclusion Criteria:

1. Age ≥65 years
2. Pregnant or breastfeeding
3. Current or recent use of the study drug
4. Known allergy to study drug
5. Current or planned participation in another pharmacological interventional trial in the next 10 days
6. Participants with known past history of dengue infection
7. Participants on aspirin, anticoagulants, or with other conditions that might increase the risk of bleeding
8. Participants on immunosuppressive agents, including long-term steroids
9. Severe dengue as defined by the WHO 2009 revised case classification.
10. Individuals with long-term immunosuppressive agents such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or those on systemic corticosteroid therapy
11. History of prior vaccination against dengue fever within one year.
12. Patients who have recently used ayurvedic or herbal medications for dengue or any other conditions in the last 7 days (eg, Papaya leaf extract)

Locations (2)

Baltimore, Maryland, United States
Bharatpur-10, Chitwan, Nepal