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

Phase 4

• 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: 19 August 2024

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

Primary Outcome Measures

Name	Time	Method
Adverse Events-AE (The AE will be classified according to Type, Location, Time of appearance, Duration, Previous knowledge, Intensity, Consequence, Causality, Result and, attitude regarding the study treatment). Measurement time: In each administration of the product and, 30 days after the last dose of the product was administered.

Secondary Outcome Measures

Name	Time	Method
A) Clinical response variables <br>1. COVID-19 infection (incidence, occurrence of complications and mortality) Measurement time: one month after the end of treatment; 6 months and, one year after starting treatment. <br>2. Infections: Number, Type (depending on the organ or system affected), Need for antibiotic treatment, Route of administration of antibiotic treatment, Need for hospital admission, Mortality. Measurement time: initial evaluation (up to 1 year before), in the evaluation one month after the treatment; 6 months and one year after starting treatment. <br>