BIOMODULINA T in a long-lived population at high risk of COVID-19 infectio

Not Applicable

Recruiting

• Conditions: SARS-CoV2; Disease Prevention; Aging; COVID-19 prevention; COVID-19; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000335
• Lead Sponsor: Centro Nacional de Biopreparados (BioCen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-19
• Study Completion: 2021-05-14
• Results First Posted: 2021-06-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events-AE (Type (Name of AE), Location (Local or Systemic), Time of appearance (immediate or late), Duration (Less than one day or Greater than one day), Previous knowledge (expected or unexpected), Intensity (mild , moderate or severe), Consequence (serious or not serious), Causation (Very probable / certain, Probable, Possible, Improbable, Not related, Not evaluable / not classifiable), Outcome of AD (Recovered, Not Recovered, Recovered with sequelae, Death or Unknown) and attitude towards the study treatment (Continuation or definitive interruption)). Measurement time: in each administration of the product up to 30 days after the last dose is administered.

Secondary Outcome Measures

Name	Time	Method
1. COVID-19 infection (incidence, occurrence of complications and mortality). Measurement time: 30 days after finished treatment. <br>2. Appetite improvement (Yes, No). Measurement time: 30 days after finished treatment. <br>3. Improvement of osteoarticular pain (Yes, No). Measurement time: 30 days after finished treatment. <br>4. Improvement of sleep disorders (Yes, No). Measurement time: 30 days after finished treatment.