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

Universidad Autonoma de Nuevo Leon

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19; SARS-CoV2 Infection

Treatments: Biological: Placebo Comparator; Biological: IMMUNEPOTENT-CRP (I-CRP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06676709

EN21-00050 (Other Identifier)

EN21-00050/LIVFCB-2021-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

I-CRP group

Experimental group

Description:

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.

Treatment:

Biological: IMMUNEPOTENT-CRP (I-CRP)

Placebo control

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo Comparator