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Celgosivir as a Treatment Against Dengue (CELADEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01619969
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : December 2, 2013
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.

Condition or disease Intervention/treatment Phase
Dengue Fever Drug: celgosivir Drug: placebo Phase 1 Phase 2

Detailed Description:
Patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be enrolled and admitted to the Investigational Medicine Unit. Patients will be randomized 1:1 to celgosivir or placebo. Capsules of placebo or celgosivir will be administered for 5 days. While in hospital, daily clinical exams will be conducted, and blood samples will be collected for viral load, quantitative NS1, hematology, clinical chemistry, cytokine levels and pharmacokinetics (PK). Safety assessments will be conducted. At discharge on Study Day 5, patients will be asked to return on Study Days 7, 10, and 15 for blood sampling and safety assessments.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever
Study Start Date : July 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: Celgosivir Drug: celgosivir
100 mg capsules, 400 mg loading dose 200 mg bid
Other Name: Bu-Cast

Placebo Comparator: Placebo Drug: placebo
Capsules of identical appearance containing starch

Primary Outcome Measures :
  1. Virological Log Reduction (Virological Endpoint) [ Time Frame: 4 days ]
  2. Fever Reduction (Clinical Endpoint) [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Safety-Proportion of patients experiencing adverse events and serious adverse events [ Time Frame: 14 days ]
    The proportion of patients experiencing adverse events and serious adverse events

  2. Quantitative NS1 and NS1 clearance [ Time Frame: 14 days ]
    NS1 non-structural protein 1

  3. Hematology [ Time Frame: 14 days ]
    Leukocytes, platelets, hematocrit

  4. Pharmacokinetics - Clearance of drug (L/hr) [ Time Frame: 5 days ]
    Clearance of drug (L/hr)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • Fever of ≥ 38°C of ≤ 48 hr duration.
  • At least two of the following criteria indicating probable dengue infection:

    • Live or work in or recent travel to dengue endemic area
    • Nausea and vomiting
    • Presence of rash
    • Aches and pains, including headache, or retro-orbital, muscle or joint pain
  • Positive NS1 strip assay

Main Exclusion Criteria:

  • Clinical signs and symptoms for severe dengue
  • Patients with certain abnormal laboratory values
  • History of presently active intestinal disorders
  • Severe diarrhea
  • Current usage of anticoagulant drugs
  • Other clinically significant acute illness
  • History of severe drug and/or food allergies
  • Exposure to investigational agent within 30 days prior to study drug administration
  • Clinically significant abnormal physical exam unrelated to dengue fever
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01619969

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Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Duke-NUS Graduate Medical School
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Study Director: Subhash Vasudevan, PhD Duke-NUS Graduate Medical School
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Singapore General Hospital Identifier: NCT01619969    
Other Study ID Numbers: 2012/025/E
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Body Temperature Changes
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral