Acute Fever of Viral EtiologyPhase 2NCT01008007
Viusid in Adults With Acute Fever of Viral Etiology
A Phase 2 study testing Viusid and Conventional treatment in people with Acute Fever of Viral Etiology, run by Catalysis SL at 1 site in Cuba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Fever of Viral Etiology
- What is being tested?
- Viusid and Conventional treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCuba
- Study dates
- Sep 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute fever of viral etiology with less than 72 hours of progression
- Signed informed consent.
Who cannot join
- Patients under treatment with other antioxidants.
- Inability to swallow the content of Viusid bags
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of VIUSID Administration on 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.
- Conditions
- Acute Fever of Viral Etiology
- Being tested
- Viusid, Conventional treatment
- Keywords
- Viusid, Dietary supplements, Acute fever, Viral etiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViusidDietary 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 treatmentDrug
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 group | Role | What they receive |
|---|---|---|
| A | Experimental | Viusid in combination with the conventional treatment for acute fever of viral etiology Receives: Dietary Supplement: Viusid |
| B | Active comparator | Conventional treatment for acute fever of viral etiology Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The platelet count improvement at 6 days (end of the treatment)
Measured: 6 days
The leukocyte count improvement at 6 days (end of the treatment)
Measured: 6 days
The granulocyte count improvement at 6 days (end of the treatment)
Measured: 6 days
Secondary outcomes (4)
Clinical symptoms disappear during the Viusid administration (6 days).
Measured: 6 days
Adverse effects during treatment
Measured: 6 days
Hemoglobin level improvement
Measured: 6 days
Hematocrit level improvement at 6 days (end of the treatment)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Fever of Viral EtiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mayra R Carrasco García, MD, Principal investigator, "Salvador Allende" Clinical-Surgical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008007
- Sponsor's protocol ID
- CAT-0911-CU
- Status last verified
- May 2010
- First submitted
- 3 Nov 2009
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology
- ClinicalTrials.gov ID
- NCT01008007
- Acronym / sponsor ID
- CAT-0911-CU
- Conditions
- Acute Fever of Viral Etiology
- Keywords
- Viusid, Dietary supplements, Acute fever, Viral etiology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: ViusidViusid in combination with the conventional treatment for acute fever of viral etiology |
| B | Active comparator | Drug: Conventional treatmentConventional treatment for acute fever of viral etiology |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute fever of viral etiology with less than 72 hours of progression
- Signed informed consent.
Key exclusion criteria (2 listed)
- Patients under treatment with other antioxidants.
- Inability to swallow the content of Viusid bags
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViusidOne 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. | Dietary supplement | A |
| Conventional treatmentConventional 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 | B |
Primary outcome
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
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayra R Carrasco García, MD principal investigator
"Salvador Allende" Clinical-Surgical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viusid and Conventional treatment in people with Acute Fever of Viral Etiology, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The platelet count improvement at 6 days (end of the treatment) (time frame: 6 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2010.