RPCEC00000335Recruiting未知
Safety and effectiveness of BIOMODULINA T in a long-lived population at high risk of COVID-19 infection. Interventional Study (COVID-19)
Centro Nacional de Biopreparados (BioCen)0 sitesStarted: September 19, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Prevention
Eligibility Criteria
- Ages
- 75 years to one (—)
- Sex
- All
Inclusion Criteria
- •1. Age 75 years and over.
- •2. Any sex and skin color.
- •3. Patients who express their consent in writing, to participate in the study and in the event that 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 intercurrent illnesses including, but not limited to: acute infections with concomitant febrile symptoms, symptomatic congestive heart failure, unstable angina pectoris.
Investigators
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