Dengue FeverPhase 2ZAP-DENGUENCT04597437
Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE)
A Phase 2 study testing Zanamivir in people with Dengue Fever, run by George Washington University at 2 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Dengue Fever
- What is being tested?
- Zanamivir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesColombia
- Study dates
- 15 Mar 2024to 31 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia2 sites, 1 recruiting
- Active, not recruiting
Cien Salud IPS SAS
Barranquilla, Atlántico, 080020
- Recruiting
Clinica de la Costa SAS
Barranquilla, Colombia, 080020
Andres Cadena, MD, acadena@clinicadelacosta.co
Camilo Fernandez, cfernandez@clinicadelacosta.co
About this study
Official title: Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE): A Pilot Randomized Controlled 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.
Read the detailed description
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. Our central hypothesis is that zanamivir treatment is safe in patients with dengue infection, will significantly decrease serum sialic acid levels, and will result in fewer patients with the development of moderate or severe clinical plasma leakage. 74 male and non-pregnant female volunteers age 7 years and older from Colombia with a diagnosis of dengue fever with warning signs or severe dengue as per the World Health Organization 2009 definition with the presence of fever and positive rapid test for the presence of dengue non-structural protein-1 (NS1) will be randomized to zanamivir versus placebo. In the treatment group, all participants weighing less than 50 kg will receive 12 mg/kg and all participants weighing 50 kg and above will receive 600 mg as the initial dose intravenously every twelve hours for 5 days adjusted for renal function. In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.
All patients will receive blood draws for assessment of hematocrit, renal function, and biologic efficacy endpoints and clinical evaluation of signs and symptoms of vascular permeability (which may include ultrasound and radiograph) and adverse events daily during the five days of medication administration and once at follow up at 14 days.
- Conditions
- Dengue Fever
- Being tested
- Zanamivir, Placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanamivirDrug
Intravenous zanamivir
PlaceboOther
In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zanamivir |
| Placebo | Placebo comparator | In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over 14 days
Secondary outcomes (2)
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.
Measured: Over 14 days
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.
Measured: Over 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Mar 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, randomized, double-blind, placebo-controlled trial of the safety and efficacy of inhaled zanamivir (n=37) versus placebo (n=37) therapy for dengue
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Medical Research Center, Clinica de la Costa, Global Disease Research, Universidad Libre de Barranquilla
- Responsible party
- Principal investigator, Aileen Y Chang, George Washington University
- Investigators
- Aileen Chang, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597437
- Sponsor's protocol ID
- NCR203024
- Acronym
- ZAP-DENGUE
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified information can be shared with other investigators. Please contact Dr. Aileen Chang at chang@email.gwu.edu