Health Trials

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Emetine 6 mgActive comparator 1 intervention
Group B: Emetine 12 mgActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate effectiveness of emetine in dengue patients assessed by 28-day mortality or progression

28-day mortality or progression to severe dengue, defined as severe plasma leakage, severe bleeding, or severe organ involvement (death and severe dengue will be assessed as a composite outcome)

Time frame
28 days
2

Safety of emetine assessed by number of adverse events

Record serious adverse events and toxicities by organ-system

Time frame
Up to 28 days
3

Safety of emetine assessed by rate of drug discontinuation

Evaluate the safety of emetine assessed by rate of drug discontinuation

Time frame
Up to 28 days

Secondary outcomes

1

Recovery (≥ 3 days without symptoms)

Sustained resolution of all dengue symptoms for ≥ 3 consecutive days (where the first of those days is considered the date of recovery)

Time frame
Up to 14 days
2

Time to Virologic Clearance of Dengue Virus by Qualitative RT-PCR

Time to test negativity that is longitudinally measured by Qualitative real-time polymerase chain reaction (RT-PCR).

Time frame
Pre-dose (day 0), day 3, and day 5
3

Quantitative Viral Load Assessment by RT-PCR Cycle Threshold (Ct) Values

Measures of the average RT-PCR cycle threshold (Ct) values for dengue virus RNA at specified time points post-randomization.

Time frame
Days 0,3, 5
4

Changes in inflammatory marker measured by hematocrit

Measure hematocrit in percentage (%) for patients

Time frame
Days 0 to 5

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Bharatpur Hospital Status unavailable Bharatpur-10, ChitwanNepalNepal

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Bharatpur Hospital Chitwan

Collaborator

Source ClinicalTrials.gov

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