Zanamivir treatment for severe dengue symptoms

Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE): A Pilot Randomized Controlled Trial

This study is testing if an intravenous treatment called zanamivir can help reduce severe symptoms in people with dengue fever, especially those at risk of serious complications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 7 Years and up
• Sex: All
• Sponsor: George Washington University (Academic / other)
• Locations: 2 sites (Barranquilla, Atlántico and 1 other locations)
• Trial ID: NCT04597437 on ClinicalTrials.gov

What this trial studies

ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation assessing the safety and efficacy of intravenous zanamivir over five days for treating vascular permeability syndrome in patients with dengue fever. The study aims to determine if zanamivir can safely reduce serum sialic acid levels and decrease the incidence of moderate to severe plasma leakage, a major cause of mortality in dengue. Participants aged 7 years and older diagnosed with dengue fever will be randomized to receive either zanamivir or a placebo, with careful monitoring of their clinical status and laboratory parameters throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are male and non-pregnant female patients aged over 7 years with a confirmed diagnosis of dengue fever exhibiting warning signs or severe symptoms.

Not a fit: Patients with mild dengue fever without warning signs or severe symptoms may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality associated with severe dengue by addressing vascular permeability issues.

How similar studies have performed: While this approach is novel in the context of dengue treatment, similar studies targeting vascular permeability in other conditions have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged \>7 years
4. Willingness to receive intravenous medication and be willing to adhere to the medication regimen
5. Have a diagnosis of dengue by dengue NS1 rapid test
6. Have had a self-informed fever \>38 degrees C in the last 3 days.
7. 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).
8. Enrollment in EPS (Entidadas Promotoras de Salud) or Sistema General de Seguridad Social en Salud (SGSSS)- Colombian Public Health Insurance.

Exclusion Criteria:

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

Where this trial is running

Barranquilla, Atlántico and 1 other locations

• Cien Salud IPS SAS — Barranquilla, Atlántico, Colombia (Active_not_recruiting)
• Clinica de la Costa SAS — Barranquilla, Colombia, Colombia (Recruiting)

Study contacts

• Principal investigator: Aileen Chang, MD — George Washington University
• Study coordinator: Aileen Y Chang, MD

Conditions Dengue Fever