Health TrialsbyHealthPanel

Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE)

ConditionDengue Fever
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7+
SponsorGeorge Washington University

About this trial

ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of five days of intravenous zanamivir treatment to treat vascular permeability syndrome which is the main cause of death in dengue fever.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Male or female, aged >7 years

Willingness to receive intravenous medication and be willing to adhere to the medication regimen

Disqualifiers

Pregnancy or lactation

Children in Care of the state

Patients who are unlikely to survive 48 hours

Unstable cardiac disease or arrhythmia at baseline

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zanamivir

    Drug

    Intravenous zanamivir

  • Placebo

    Other intervention

    In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: ZanamivirExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events of intravenous zanamivir treatment versus placebo in dengue

Incidence of Treatment-Emergent Adverse Events will be assessed by daily active surveillance during drug administration and at 2-week follow-up as per the United States Food and Drug Administration guidelines.

Time frame
Over 14 days

Secondary outcomes

1

Levels of endothelial glycocalyx biomarkers in intravenous zanamivir treatment versus placebo in dengue

Serum concentration of key endothelial glycocalyx components due to endothelial damage such as sialic acid, heparan sulfate, and syndecan-1 will be assessed by ELISA. Serum concentration of sialidases (NEU2 and NEU3) that are directly inhibited by zanamivir will be assessed by ELISA.

Time frame
Over 14 days
2

Preliminary clinical efficacy of intravenous zanamivir treatment versus placebo in dengue

Presence of moderate or severe plasma leakage as defined by the Standard Clinical Endpoints for Use in Dengue Interventional Trials where moderate plasma leakage is defined as 15% change in hematocrit or evidence of fluid on ultrasound or X-ray and severe plasma leakage is defined at the presence of shock or respiratory compromise with evidence of plasma leakage.

Time frame
Over 14 days

Other outcomes

Sponsors and contacts

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George Washington University

Lead sponsor

Naval Medical Research Center

Collaborator

Clinica de la Costa

Collaborator

Global Disease Research

Collaborator

Universidad Libre de Barranquilla

Collaborator

Source ClinicalTrials.gov
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