Completed

NCT Number: NCT01008007

Viusid in Adults With Acute Fever of Viral Etiology

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.

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Key information

Conditions

Acute Fever of Viral Etiology

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

"Salvador Allende" Clinical-Surgical Hospital

Havana, La Habana, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Nov 5, 2009
Registry last updated: May 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.