Biomodulina T - IM- covid-19 - older adultos - Phase IV clinical trial

Phase 4

Completed

• Conditions: Prevention of infections, including covid-19; Covid-19; SARS-CoV2; Disease Prevention; Aging; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000310
• Lead Sponsor: Centro Nacional de Biopreparados (BioCen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-05
• Results First Posted: 2021-09-01
• Study Completion: 2022-09-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 60 years and over.
2. Any sex and skin color.
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.

Study & Design

• Study Type: Observational
• Study Design: Not specified