Viusid in Adults With Acute Fever of Viral Etiology

• ClinicalTrials.gov Identifier: NCT01008007
• Recruitment Status: Completed
• First Posted: November 5, 2009
• Last Update Posted: May 18, 2010
• Sponsor: Catalysis SL
• Information provided by: Catalysis SL

Tracking Information

• First Submitted Date: November 3, 2009
• First Posted Date: November 5, 2009
• Last Update Posted Date: May 18, 2010
• Study Start Date: September 2009
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2009)

• The platelet count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
• The leukocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
• The granulocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 3, 2009)

• Clinical symptoms disappear during the Viusid administration (6 days). [ Time Frame: 6 days ]
• Adverse effects during treatment [ Time Frame: 6 days ]
• Hemoglobin level improvement [ Time Frame: 6 days ]
• Hematocrit level improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Viusid in Adults With Acute Fever of Viral Etiology
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Fever of Viral Etiology

Intervention

• Dietary Supplement: Viusid
  One Viusid bag (4 grams, orally administered) every 8 hours, for 6 days in combination with the conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea.
• Drug: Conventional treatment
  Conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea.

Study Arms

• Experimental: A
  Viusid in combination with the conventional treatment for acute fever of viral etiology
  Intervention: Dietary Supplement: Viusid
• Active Comparator: B
  Conventional treatment for acute fever of viral etiology
  Intervention: Drug: Conventional treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 3, 2009): 200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2010
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Acute fever of viral etiology with less than 72 hours of progression
• Signed informed consent.

Exclusion Criteria:

• Patients under treatment with other antioxidants.
• Inability to swallow the content of Viusid bags

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Cuba

Administrative Information

• NCT Number: NCT01008007
• Other Study ID Numbers: CAT-0911-CU
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mayra R. Carrasco García, "Salvador Allende" Clinical-Surgical Hospital
• Study Sponsor: Catalysis SL
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mayra R Carrasco García, MD; "Salvador Allende" Clinical-Surgical Hospital

• PRS Account: Catalysis SL
• Verification Date: May 2010