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 inoutpatients with COVID-19 were examined. I-CRP has been previously studied for itsability 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 ifsimilar 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.
Biological: 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.
Other Name: Bovine Dialyzable Leukocyte Extract (DLE)
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).
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.
Hospital Universitario "Dr. Jose E. Gonzalez", Universidad Autonoma de Nuevo Leon
Monterrey 3995465, Nuevo León 3522542, Mexico
Laboratorio de Inmunologia y Virologia
San Nicolás de los Garza 3985241, Nuevo León 3522542, Mexico