Viusid in Adults With Acute Fever of Viral Etiology

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Fever of Viral Etiology

Intervention / Treatment
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* Dietary Supplement: Viusid
* Drug: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Viusid in combination with the conventional treatment for acute fever of viral etiology | Dietary Supplement: Viusid<br>* 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.<br>|
| Active Comparator: B<br>Conventional treatment for acute fever of viral etiology | Drug: Conventional treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viusid, Dietary supplements, Acute fever, Viral etiology