Biomodulina T - IM - covid-19 - older adult

Not Applicable

• Conditions: Prevention of infections including COVID-19; COVID-19; SARS-CoV2; Infections; Disease Prevention; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; SARS Virus; Betacoronavirus

• Registration Number: RPCEC00000319
• Lead Sponsor: Centro Nacional de Biopreparados (BIOCEN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-29
• Results First Posted: 2021-09-01
• Study Completion: 2021-09-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory infections (Number (0 to infinity), Type (- High Respiratory, including a common cold, Sinusitis, Otitis, Laryngitis or Pharyngotonsillitis; - Low Respiratory such as Bronchitis, Bronchopneumonia), Etiology (Bacterial, Viral, Fungal or Parasitic), Need for antibiotic treatment (Yes or No), Route of administration of antibiotic treatment (Oral or Parenteral), Need for hospital admission (Yes or No) and Mortality due to infection (Yes or No). Measurement time: In the initial evaluation, in the monthly evaluation and final evaluation (6 weeks)