A Phase 1/2 interventional study of IMMUNEPOTENT-CRP (I-CRP) and Placebo Comparator in COVID-19 and SARS-CoV2 Infection, sponsored by Universidad Autonoma de Nuevo Leon. Completed at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Universidad Autonoma de Nuevo Leon · Phase 1/2, Interventional, and Treatment
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.
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.
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Outpatients Inclusion Criteria:
Outpatients Exclusion Criteria:
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.
Biological: IMMUNEPOTENT-CRP (I-CRP)
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.
Biological: Placebo Comparator
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.
Also known as: Bovine Dialyzable Leukocyte Extract (DLE)
The placebo was prepared from a lyophilized corn starch extract and was provided in an identical appearance and presentation to IMMUNEPOTENT-CRP (I-CRP).
Cytokine and Chemokine Serum Levels Evaluation
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.
Time frame: Assessments were performed at baseline (Day 0), and during the intervention period at Day 7 and Day 14.
Lactate Dehydrogenase (LDH) Levels
Plasma levels of lactate dehydrogenase (LDH) were measured using standard biochemistry tests. Reference normal values are 230-460 mg/dL.
Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
High-Sensitivity C-Reactive Protein (hs-CRP) Levels
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.
Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
Ferritin Levels
Serum levels of ferritin were measured using standard biochemistry tests. Reference normal values are 13-150 ng/mL.
Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
D-Dimer Levels
Plasma levels of D-dimer were measured using standard biochemistry tests. Reference normal values are 0.0-0.5 μg/mL.
Time frame: Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.
Lymphocyte Subpopulations
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).
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.
SARS-CoV-2 Infection Status Evaluation
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.
Time frame: SARS-CoV-2 infection status was evaluated at baseline (Day 0), Day 7, Day 14, and Day 30 during outpatient follow-up.
Plan to share: Yes — The individual participant data (IPD) to be shared with other researchers will include the following variables related to the study participants: * Basic demographic information (such age, sex, and others) * Serum levels of pro-inflammatory cytokines * Relevant clinical data related to SARS-CoV-2 infection, such as symptom severity and clinical progression * Data on treatment group allocation (IMMUNEPOTENT-CRP or placebo) Prior to sharing the data, all identifiable participant information will be anonymized to ensure privacy and confidentiality. Measures will be taken to prevent any possible re-identification of participants.
Supporting information: Study protocol, Sap, Analytic code
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Universidad Autonoma de Nuevo Leon