Viusid in Adults With Acute Fever of Viral Etiology

NCT01008007 | Completed Phase 2 DMC

• 1 other identifier: CAT-0911-CU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Fever of Viral Etiology

Keywords

Viusid; Dietary supplements; Acute fever; Viral etiology

Outcome Measures

Primary Outcomes (3)

• The platelet count improvement at 6 days (end of the treatment)

  6 days

• The leukocyte count improvement at 6 days (end of the treatment)

  6 days

• The granulocyte count improvement at 6 days (end of the treatment)

  6 days

Secondary Outcomes (4)

• Clinical symptoms disappear during the Viusid administration (6 days).

  6 days

• Adverse effects during treatment

  6 days

• Hemoglobin level improvement

  6 days

• Hematocrit level improvement at 6 days (end of the treatment)

  6 days

Study Arms (2)

A

EXPERIMENTAL

Viusid in combination with the conventional treatment for acute fever of viral etiology

Dietary Supplement: Viusid

B

ACTIVE COMPARATOR

Conventional treatment for acute fever of viral etiology

Drug: Conventional treatment

Interventions

Viusid DIETARY_SUPPLEMENT

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.

A

Conventional treatment DRUG

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.

B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

"Salvador Allende" Clinical-Surgical Hospital

Havana, La Habana, Cuba

Location

MeSH Terms

Interventions

Viusid

Study Officials

• Mayra R Carrasco García, MD

  "Salvador Allende" Clinical-Surgical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 5, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 18, 2010

Record last verified: 2010-05

Locations

CU (1)