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

NCT04597437 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NCR203024
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dengue Fever

Outcome Measures

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.

  Over 14 days

Secondary Outcomes (2)

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

  Over 14 days

• Preliminary clinical efficacy of intravenous zanamivir treatment versus placebo in dengue

  Over 14 days

Study Arms (2)

Zanamivir

EXPERIMENTAL

In the treatment group, participants weighing less than 50 kg will receive 12 mg/kg and those weighing 50 kg and above will receive 600 mg as the initial dose intravenously every twelve hours for 5 days adjusted for renal function.

Drug: Zanamivir

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Zanamivir DRUG

Intravenous zanamivir

Zanamivir

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have a diagnosis of dengue by dengue NS1 rapid test
• Have had a self-informed fever \>38 degrees C in the last 3 days.
• Have dengue with warning signs as per the 2009 WHO criteria including one of the following: abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy, restlessness, liver enlargement over 2 cm, augmented hematocrit, thrombocytopenia or severe dengue defined as dengue with severe plasma leakage leading to dengue shock and/or fluid accumulation with respiratory distress; severe hemorrhage; severe organ impairment (hepatic damage, renal impairment, cardiomyopathy, encephalopathy or encephalitis).
• Enrollment in EPS (Entidadas Promotoras de Salud) or Sistema General de Seguridad Social en Salud (SGSSS)- Colombian Public Health Insurance.

You may not qualify if:

• Pregnancy or lactation
• Children in Care of the state
• Patients who are unlikely to survive 48 hours
• Unstable cardiac disease or arrhythmia at baseline
• History of significant cardiac disease
• Treatment with another investigational drug or other intervention within 1 month.
• Encephalitis or unable to consent

Sponsors & Collaborators

• George Washington University: lead
• Naval Medical Research Center: collaborator
• Clinica de la Costa: collaborator
• Global Disease Research: collaborator
• Universidad Libre de Barranquilla: collaborator

Study Sites (2)

Cien Salud IPS SAS

Barranquilla, Atlántico, 080020, Colombia

ACTIVE NOT RECRUITING

Clinica de la Costa SAS

Barranquilla, Colombia, 080020, Colombia

RECRUITING

MeSH Terms

Conditions

Dengue

Interventions

Zanamivir

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Sialic Acids; Neuraminic Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amino Sugars; Carbohydrates

Study Officials

• Aileen Chang, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aileen Y Chang, MD

CONTACT

202-741-6562; chang@email.gwu.edu

Alfonso Sucerquia, MD

CONTACT

202-741-6562; alfonso.sucerquiahernandez@email.gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Pilot, randomized, double-blind, placebo-controlled trial of the safety and efficacy of inhaled zanamivir (n=37) versus placebo (n=37) therapy for dengue

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: March 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)