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Completed

NCT Number: NCT06676709

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Cytokine Release Syndrome Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV2 Infection Shock Systemic Inflammatory Response Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMMUNEPOTENT-CRP (I-CRP)

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.

Other names: Bovine Dialyzable Leukocyte Extract (DLE)

Placebo comparator

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).

Primary outcomes

  1. Cytokine and Chemokine Serum Levels Evaluation

    Time frame: Assessments were performed at baseline (Day 0), and during the intervention period at Day 7 and Day 14.

    Serum levels of IL-1β, IL-6, IL-10, TNF-α, IFN-α, IFN-γ, and IL-8 were measured using the Human Cytokine/Chemokine Magnetic Bead Panel (Milliplex, Darmstadt, Germany). Cytokine and chemokine concentrations in the serum are expressed in pg/mL.

Secondary outcomes

  1. Lactate Dehydrogenase (LDH) Levels

    Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.

    Plasma levels of lactate dehydrogenase (LDH) were measured using standard biochemistry tests. Reference normal values are 230-460 mg/dL.

  2. High-Sensitivity C-Reactive Protein (hs-CRP) Levels

    Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.

    Serum levels of high-sensitivity C-reactive protein (hs-CRP) were measured using standard biochemistry tests. Reference normal values are 0.0-0.3 mg/dL.

  3. Ferritin Levels

    Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.

    Serum levels of ferritin were measured using standard biochemistry tests. Reference normal values are 13-150 ng/mL.

  4. D-Dimer Levels

    Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.

    Plasma levels of D-dimer were measured using standard biochemistry tests. Reference normal values are 0.0-0.5 μg/mL.

  5. Lymphocyte Subpopulations

    Time frame: 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.

    The percentages (%) of lymphocyte subpopulations in whole blood were determined using the BD Multitest 6-color TBNK reagent kit (BD Biosciences, San Jose, USA) and analyzed with the BD FACSCanto™ flow cytometer (BD Biosciences).

  6. SARS-CoV-2 Infection Status Evaluation

    Time frame: SARS-CoV-2 infection status was evaluated at baseline (Day 0), Day 7, Day 14, and Day 30 during outpatient follow-up.

    Nasopharyngeal/oropharyngeal (NP/OP) flocked swabs collected in 3-5 mL of viral transport medium (VTM) were used to determine SARS-CoV-2 infection status via RT-qPCR. The 2019-nCoV CDC EUA Kit (IDT, Coralville, USA) primers and probe set were used for the assay. RT-qPCR results with a sigmoidal amplification curve and a cycle threshold (Ct) value of ≤37 were considered positive for SARS-CoV-2, while Ct values of 38 and above were considered negative.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez
  • Laboratorio de Inmunologia y Virologia - UANL

Registry information

Official study 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

Acronym: ICRPDLECOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 6, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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