Trial record 11 of 22 for:
Viusid
Viusid in Adults With Acute Fever of Viral Etiology
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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. |
ClinicalTrials.gov Identifier: NCT01008007 |
Recruitment Status :
Completed
First Posted : November 5, 2009
Last Update Posted : May 18, 2010
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Sponsor:
Catalysis SL
Information provided by:
Catalysis SL
Tracking Information | ||||
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First Submitted Date ICMJE | November 3, 2009 | |||
First Posted Date ICMJE | November 5, 2009 | |||
Last Update Posted Date | May 18, 2010 | |||
Study Start Date ICMJE | September 2009 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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 | Viusid in Adults With Acute Fever of Viral Etiology | |||
Official Title ICMJE | Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology | |||
Brief Summary | The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams) administration in the treatment of acute fever of viral etiology as diagnosed by clinical, hematologic and serologic parameters. The duration of this open and randomized phase 2 clinical trial will be 6 days. The estimated number of persons with acute fever of viral etiology to be recruited and randomized for the study is 200. The primary outcome measure: platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of the study. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acute Fever of Viral Etiology | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
200 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Cuba | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01008007 | |||
Other Study ID Numbers ICMJE | CAT-0911-CU | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Mayra R. Carrasco García, "Salvador Allende" Clinical-Surgical Hospital | |||
Study Sponsor ICMJE | Catalysis SL | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Catalysis SL | |||
Verification Date | May 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |