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Clinical Trials/RPCEC00000319
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.

Registry
who.int
Start Date
May 29, 2020
End Date
September 4, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Centro Nacional de Biopreparados (BIOCEN)

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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