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

NCT ID: NCT06676709

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-03-05

Brief 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.

Detailed Description

Outpatients with mild to moderate COVID-19 symptoms and a confirmed SARS-CoV-2 infection were enrolled. These patients were randomly assigned to receive either IMMUNEPOTENT-CRP (I-CRP) or a placebo over a 14-day period. The study was double-blind, meaning neither the patients nor the researchers knew who was receiving I-CRP or placebo, ensuring unbiased results. The main objective of the study was to measure changes in the levels of specific cytokines and chemokines in the blood-IL-1β, IL-6, IL-10, TNF-α, IFN-α, IFN-γ, and IL-8-which are key players in the inflammatory response linked to severe COVID-19 cases. High levels of these molecules are associated with worse outcomes and more severe symptoms. Additionally, other markers of inflammation and immune system activity, such as lactate dehydrogenase (LDH), high-sensitivity C-reactive protein (hs-CRP), ferritin, and D-dimer, were measured, as these are commonly used to assess the severity of inflammation and risk of complications in COVID-19 patients.

Throughout the study, outpatients were regularly monitored for symptoms, and their vital signs-such as oxygen levels and body temperature-were checked during home visits. Blood samples were collected at different intervals to measure cytokine levels and the other included inflammatory markers. Patients were also tested four times for the presence of the virus to determine their infection status during the follow-up period.

Conditions

COVID-19; SARS-CoV2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

I-CRP group

IMMUNEPOTENT-CRP (I-CRP) was supplied in a 5 Unit (U) per vial presentation. One U is defined as the lyophilized product obtained from the dialysis of 1×10\^8 bovine spleen cells. The dosing schedule extended over 14 days. On the first day (Day 0), outpatients ingested seven doses at two-hour intervals each one. From days one through four, four doses were taken one every four hours, and from days five to thirteen, three doses were consumed one every eight hours.

Group Type: EXPERIMENTAL

IMMUNEPOTENT-CRP (I-CRP)

Intervention Type: BIOLOGICAL

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.

Placebo control

The placebo was prepared from a lyophilized corn starch extract and was provided in an identical appearance and presentation to IMMUNEPOTENT-CRP (I-CRP). The dosing schedule extended over 14 days. On the first day (Day 0), outpatients ingested seven doses at two-hour intervals each one. From days one through four, four doses were taken one every four hours, and from days five to thirteen, three doses were consumed one every eight hours.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: 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).

Intervention Type: BIOLOGICAL

Other Intervention Names

Bovine Dialyzable Leukocyte Extract (DLE)

Eligibility Criteria

Inclusion Criteria

• Laboratory-confirmed SARS-CoV-2 infection (by antigen or RT-qPCR test).
• With mild to moderate symptoms of COVID-19.
• Aged ≥ 18 years.
• Not participating in any other clinical study.
• Written informed consent duly signed.

Exclusion Criteria

• Undergoing any process of primary or secondary immunosuppression.
• Any autoimmune disease.
• Receiving chemotherapy.
• History of lymphoma or any malignancy.
• Pregnancy or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorio de Inmunologia y Virologia - UANL

OTHER

Sponsor Role: collaborator

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: collaborator

Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jose Manuel Vazquez-Guillen

Full-Time Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Rodriguez-Padilla, Ph.D.

Role: STUDY_DIRECTOR

Universidad Autonoma de Nuevo Leon

Rene Rodriguez-Gutierrez, Ph.D.

Role: STUDY_CHAIR

Universidad Autonoma de Nuevo Leon

Jose Manuel Vazquez-Guillen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonoma de Nuevo Leon

Locations

Hospital Universitario "Dr. Jose E. Gonzalez", Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, Mexico

Laboratorio de Inmunologia y Virologia

San Nicolás de los Garza, Nuevo León, Mexico

Countries

Mexico

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Other Identifiers

EN21-00050

Identifier Type: OTHER

Identifier Source: secondary_id

EN21-00050/LIVFCB-2021-001

Identifier Type: -

Identifier Source: org_study_id