RPCEC00000319
Completed
未知
Evaluation of the efficacy and safety of a new BIOMODULINA T® dosage scheme for the prevention of infections, including COVID-19, in older adults in Cuba. Confirmatory study (COVID-19)
Centro Nacional de Biopreparados (BIOCEN)0 sites160 target enrollmentMay 29, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Prevention of infections including COVID-19
- Sponsor
- Centro Nacional de Biopreparados (BIOCEN)
- Enrollment
- 160
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who meet the diagnostic criteria
- •2\. Any sex and skin color aged 60 years and over.
- •3\. Patients who express their consent in writing, to participate in the study and in case major cognitive impairment is present, be signed by a family member, tutor or caregiver.
Exclusion Criteria
- •1\. Patients who have received treatment with BIOMODULINA T® in the previous two months.
- •2\. Patients with known hypersensitivity to any component of the formulation.
- •3\. Patients with acute allergic states or history of severe allergic reactions.
- •4\. Patients with uncontrolled breakthrough diseases including, but not limited to: acute infections with concomitant febrile illness, symptomatic congestive heart failure, unstable angina pectoris.
Outcomes
Primary Outcomes
Not specified
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