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Effect of IMMUNEPOTENT-CRP on Serum Pro-Inflammatory Cytokines in Mild to Moderate COVID-19

NCT06676709 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-08

No results posted yet for this study

Summary

In this study, the effects of IMMUNEPOTENT-CRP (I-CRP), a dialyzable leukocyte extract (DLE) derived from bovine spleen cells, on the levels of key inflammatory cytokines in outpatients with COVID-19 were examined. I-CRP has been previously studied for its ability to regulate the immune system in other conditions, such as cancer and sepsis. Based on its potential to reduce harmful inflammation, the study aimed to determine if similar benefits could be observed in COVID-19 outpatients.

Conditions

Interventions

BIOLOGICAL

IMMUNEPOTENT-CRP (I-CRP)

IMMUNEPOTENT-CRP (I-CRP), a bovine dialyzable leukocyte extract (DLE) obtained from disrupted spleen cells, is a mixture of low-molecular-weight peptides (\<12 kDa) that exhibit non-specific immunomodulatory properties.

BIOLOGICAL

Placebo Comparator

The placebo was prepared from a lyophilized corn starch extract and was provided in an identical appearance and presentation to IMMUNEPOTENT-CRP (I-CRP).

Sponsors & Collaborators

  • Laboratorio de Inmunologia y Virologia - UANL

    collaborator OTHER

  • Hospital Universitario Dr. Jose E. Gonzalez

    collaborator OTHER

  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Cristina Rodriguez-Padilla, Ph.D. · Universidad Autonoma de Nuevo Leon

  • Rene Rodriguez-Gutierrez, Ph.D. · Universidad Autonoma de Nuevo Leon

  • Jose Manuel Vazquez-Guillen, Ph.D. · Universidad Autonoma de Nuevo Leon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2022-02-03
Completion
2022-03-05

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676709 on ClinicalTrials.gov