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

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ClinicalTrials.gov Identifier: NCT04597437
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Naval Medical Research Center
Hospital Infantil de Niño Jesús de Barranquilla (HINJ)
Universidad Bosque
Allied Research Society
Information provided by (Responsible Party):
George Washington University

Tracking Information
First Submitted Date  ICMJE October 9, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date October 22, 2020
Estimated Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
Incidence of Treatment-Emergent Adverse Events of intravenous zanamivir treatment versus placebo in dengue [ Time Frame: Over 14 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • Levels of endothelial glycocalyx biomarkers in intravenous zanamivir treatment versus placebo in dengue [ Time Frame: Over 14 days ]
    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.
  • Preliminary clinical efficacy of intravenous zanamivir treatment versus placebo in dengue [ Time Frame: Over 14 days ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE)
Official Title  ICMJE Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE): A Pilot Randomized Controlled Trial
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.
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, participants will receive 600 mg for adults and 12 mg/kg in children 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dengue Fever
Intervention  ICMJE
  • Drug: Zanamivir
    Intravenous zanamivir
  • Other: Placebo
    In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.
Study Arms  ICMJE
  • Experimental: Zanamivir
    In the treatment group, participants will receive 600 mg for adults and 12 mg/kg in children intravenously every twelve hours for 5 days adjusted for renal function.
    Intervention: Drug: Zanamivir
  • Placebo Comparator: Placebo
    In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2020)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 documented fever >38C in the last 24 hours.
  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).

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Children in Care of the state
  3. Patients who are unlikely to survive 48 hours
  4. Elevated alanine aminotransferase ≥3 times the upper limit of normal (ULN)
  5. Total bilirubin ≥2 × ULN
  6. Unstable cardiac disease or arrhythmia at baseline
  7. History of significant cardiac disease
  8. Treatment with another investigational drug or other intervention within 1 month.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aileen Y Chang, MD 202-741-6562 chang@email.gwu.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04597437
Other Study ID Numbers  ICMJE NCR203024
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: De-identified information can be shared with other investigators. Please contact Dr. Aileen Chang at chang@email.gwu.edu
Responsible Party George Washington University
Study Sponsor  ICMJE George Washington University
Collaborators  ICMJE
  • Naval Medical Research Center
  • Hospital Infantil de Niño Jesús de Barranquilla (HINJ)
  • Universidad Bosque
  • Allied Research Society
Investigators  ICMJE Not Provided
PRS Account George Washington University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP