Clinical trial NCT06676709: Effect of IMMUNEPOTENT-CRP on Serum Pro-Inflammatory Cytokines in Mild to Moderate COVID-19
Official title: Effect of IMMUNEPOTENT-CRP, a Bovine Dialyzable Leukocyte Extract, on Serum Pro-Inflammatory Cytokines in Outpatients with Mild to Moderate COVID-19: a Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
SARS-CoV2 Infection
Keywords: Cytokine storm
Mild to moderate COVID-19
Inflammatory cytokines
Dialyzable Leukocyte Extract (DLE)
IMMUNEPOTENT-CRP (I-CRP)
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
Collaborators: name: Laboratorio de Inmunologia y Virologia - UANL
name: Hospital Universitario Dr. Jose E. Gonzalez
First posted: 2024-11-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Outpatients 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.

Outpatients 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.

Primary outcomes:
measure: Cytokine and Chemokine Serum Levels Evaluation
timeFrame: Assessments were performed at baseline (Day 0), and during the intervention period at Day 7 and Day 14.
Secondary outcomes:
measure: Lactate Dehydrogenase (LDH) Levels
timeFrame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
measure: High-Sensitivity C-Reactive Protein (hs-CRP) Levels
timeFrame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
measure: Ferritin Levels
timeFrame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
measure: D-Dimer Levels
timeFrame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
measure: Lymphocyte Subpopulations
timeFrame: Lymphocyte subpopulation counts in whole blood were measured at baseline (Day 0), Day 7, and Day 14 during the administration of I-CRP or placebo.
measure: SARS-CoV-2 Infection Status Evaluation
timeFrame: SARS-CoV-2 infection status was evaluated at baseline (Day 0), Day 7, Day 14, and Day 30 during outpatient follow-up.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose E. Gonzalez", Universidad Autonoma de Nuevo Leon
state: Nuevo Leon
city: San Nicolas de los Garza
country: Mexico
facility: Laboratorio de Inmunologia y Virologia
state: Nuevo Leon
Study officials:
affiliation: Universidad Autonoma de Nuevo Leon
name: Cristina Rodriguez-Padilla, Ph.D.
role: STUDY_DIRECTOR
affiliation: Universidad Autonoma de Nuevo Leon
name: Rene Rodriguez-Gutierrez, Ph.D.
role: STUDY_CHAIR
affiliation: Universidad Autonoma de Nuevo Leon
name: Jose Manuel Vazquez-Guillen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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