drugset / Trial / NCT06676709
Effect of IMMUNEPOTENT-CRP on Serum Pro-Inflammatory Cytokines in Mild to Moderate COVID-19
Phase 1/2
Completed
80 enrolled
Autonomous University of Nuevo León
Hospital Universitario Dr. Jose E. Gonzalez · collabLaboratorio de Inmunologia y Virologia - UANL · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-04-20
- Primary completion
- 2022-02-03
- Completion
- 2022-03-05
Publications
- Background Franco-Molina MA, Santana-Krímskaya SE, Zarate-Triviño DG, Zapata-Benavides P, Hernández-Martínez SP, Cervantes-Wong F, et al. Bovine dialyzable leukocyte extract immunepotent CRP: Evaluation of biological activity of the modified product. Appl Sci 2021;11. https://doi.org/10.3390/app11083505.
- Background Ayala MC, Gonzalez NM, Palacios G, Rivera-Morales LG, Rodriguez-Padilla C. [Dialyzed leukocyte extracts for the treatment of recurrent and severe infections in pediatric patients with cellular immunodeficiency: 15 years of experience]. Rev Alerg Mex. 2019 Jan-Mar;66(1):27-37. doi: 10.29262/ram.v66i1.531. Spanish.
- Background Franco-Molina MA, Mendoza-Gamboa E, Castillo-Leon L, Tamez-Guerra RS, Rodriguez-Padilla C. Bovine dialyzable leukocyte extract protects against LPS-induced, murine endotoxic shock. Int Immunopharmacol. 2004 Dec 15;4(13):1577-86. doi: 10.1016/j.intimp.2004.06.014.
- Background Armides Franco-Molina M, Mendoza-Gamboa E, Castillo-Tello P, Tamez-Guerra RS, Villarreal-Trevino L, Tijerina-Menchaca R, Castillo-Leon L, Zapata-Benavides P, Rodriguez-Padilla C. In vitro antibacterial activity of bovine dialyzable leukocyte extract. Immunopharmacol Immunotoxicol. 2006;28(3):471-83. doi: 10.1080/08923970600928072.
- Background Franco-Molina MA, Mendoza-Gamboa E, Miranda-Hernandez D, Zapata-Benavides P, Castillo-Leon L, Isaza-Brando C, Tamez-Guerra RS, Rodriguez-Padilla C. In vitro effects of bovine dialyzable leukocyte extract (bDLE) in cancer cells. Cytotherapy. 2006;8(4):408-14. doi: 10.1080/14653240600847266.
- Background Mendoza-Gamboa E, Franco-Molina MA, Zapata-Benavides P, Castillo-Tello P, Vera-Garcia ME, Tamez-Guerra RS, Rodriguez-Padilla C. Bovine dialyzable leukocyte extract modulates AP-1 DNA-binding activity and nuclear transcription factor expression in MCF-7 breast cancer cells. Cytotherapy. 2008;10(2):212-9. doi: 10.1080/14653240801891659.
- Background Franco-Molina MA, Mendoza-Gamboa E, Zapata-Benavides P, Castillo-Tello P, Isaza-Brando CE, Zamora-Avila D, Rivera-Morales LG, Miranda-Hernandez DF, Sierra-Rivera CA, Vera-Garcia ME, Tamez-Guerra RS, Rodriguez-Padilla C. Antiangiogenic and antitumor effects of IMMUNEPOTENT CRP in murine melanoma. Immunopharmacol Immunotoxicol. 2010 Dec;32(4):637-46. doi: 10.3109/08923971003663253. Epub 2010 Mar 5.
- Background Lara HH, Ixtepan-Turrent L, Garza-Trevino EN, Badillo-Almaraz JI, Rodriguez-Padilla C. Antiviral mode of action of bovine dialyzable leukocyte extract against human immunodeficiency virus type 1 infection. BMC Res Notes. 2011 Nov 1;4:474. doi: 10.1186/1756-0500-4-474.
- Background Sierra-Rivera CA, Franco-Molina MA, Mendoza-Gamboa E, Zapata-Benavides P, Santaolalla-Tapia J, Coronado-Cerda EE, Tamez-Guerra RS, Rodriguez-Padilla C. Effect of bovine dialyzable leukocyte extract on induction of cell differentiation and death in K562 human chronic myelogenous leukemia cells. Oncol Lett. 2016 Dec;12(6):4449-4460. doi: 10.3892/ol.2016.5285. Epub 2016 Oct 18.
- Background Lorenzo-Anota HY, Reyes-Ruiz A, Calvillo-Rodriguez KM, Mendoza-Reveles R, Urdaneta-Peinado AP, Alvarez-Valadez KM, Martinez-Torres AC, Rodriguez-Padilla C. IMMUNEPOTENT CRP increases intracellular calcium through ER-calcium channels, leading to ROS production and cell death in breast cancer and leukemic cell lines. EXCLI J. 2023 Mar 16;22:352-366. doi: 10.17179/excli2022-5568. eCollection 2023.
- Background Garcia Coronado PL, Franco Molina MA, Zarate Trivino DG, Menchaca Arredondo JL, Zapata Benavides P, Rodriguez Padilla C. Putative Wound Healing Induction Functions of Exosomes Isolated from IMMUNEPOTENT CRP. Int J Mol Sci. 2023 May 18;24(10):8971. doi: 10.3390/ijms24108971.
- Background Calvillo-Rodriguez KM, Lorenzo-Anota HY, Rodriguez-Padilla C, Martinez-Torres AC, Scott-Algara D. Immunotherapies inducing immunogenic cell death in cancer: insight of the innate immune system. Front Immunol. 2023 Nov 23;14:1294434. doi: 10.3389/fimmu.2023.1294434. eCollection 2023.
- Background Coronado-Cerda EE, Franco-Molina MA, Mendoza-Gamboa E, Prado-Garcia H, Rivera-Morales LG, Zapata-Benavides P, Rodriguez-Salazar Mdel C, Caballero-Hernandez D, Tamez-Guerra RS, Rodriguez-Padilla C. In Vivo Chemoprotective Activity of Bovine Dialyzable Leukocyte Extract in Mouse Bone Marrow Cells against Damage Induced by 5-Fluorouracil. J Immunol Res. 2016;2016:6942321. doi: 10.1155/2016/6942321. Epub 2016 Apr 17.
- Background Rodriguez-Salazar MDC, Franco-Molina MA, Mendoza-Gamboa E, Martinez-Torres AC, Zapata-Benavides P, Lopez-Gonzalez JS, Coronado-Cerda EE, Alcocer-Gonzalez JM, Tamez-Guerra RS, Rodriguez-Padilla C. The novel immunomodulator IMMUNEPOTENT CRP combined with chemotherapy agent increased the rate of immunogenic cell death and prevented melanoma growth. Oncol Lett. 2017 Jul;14(1):844-852. doi: 10.3892/ol.2017.6202. Epub 2017 May 18.
- Background Martinez-Torres AC, Reyes-Ruiz A, Benitez-Londono M, Franco-Molina MA, Rodriguez-Padilla C. IMMUNEPOTENT CRP induces cell cycle arrest and caspase-independent regulated cell death in HeLa cells through reactive oxygen species production. BMC Cancer. 2018 Jan 3;18(1):13. doi: 10.1186/s12885-017-3954-5.
- Background Martinez-Torres AC, Gomez-Morales L, Martinez-Loria AB, Uscanga-Palomeque AC, Vazquez-Guillen JM, Rodriguez-Padilla C. Cytotoxic activity of IMMUNEPOTENT CRP against non-small cell lung cancer cell lines. PeerJ. 2019 Sep 27;7:e7759. doi: 10.7717/peerj.7759. eCollection 2019.
- Background Santana-Krimskaya SE, Franco-Molina MA, Zarate-Trivino DG, Prado-Garcia H, Zapata-Benavides P, Torres-Del-Muro F, Rodriguez-Padilla C. IMMUNEPOTENT CRP plus doxorubicin/cyclophosphamide chemotherapy remodel the tumor microenvironment in an air pouch triple-negative breast cancer murine model. Biomed Pharmacother. 2020 Jun;126:110062. doi: 10.1016/j.biopha.2020.110062. Epub 2020 Mar 12.
- Background Lorenzo-Anota HY, Martinez-Torres AC, Scott-Algara D, Tamez-Guerra RS, Rodriguez-Padilla C. Bovine Dialyzable Leukocyte Extract IMMUNEPOTENT-CRP Induces Selective ROS-Dependent Apoptosis in T-Acute Lymphoblastic Leukemia Cell Lines. J Oncol. 2020 Jun 8;2020:1598503. doi: 10.1155/2020/1598503. eCollection 2020.
- Background Martinez-Torres AC, Reyes-Ruiz A, Calvillo-Rodriguez KM, Alvarez-Valadez KM, Uscanga-Palomeque AC, Tamez-Guerra RS, Rodriguez-Padilla C. IMMUNEPOTENT CRP induces DAMPS release and ROS-dependent autophagosome formation in HeLa and MCF-7 cells. BMC Cancer. 2020 Jul 13;20(1):647. doi: 10.1186/s12885-020-07124-5.
- Background Lorenzo-Anota HY, Martinez-Loria AB, Tamez-Guerra RS, Scott-Algara D, Martinez-Torres AC, Rodriguez-Padilla C. Changes in the natural killer cell repertoire and function induced by the cancer immune adjuvant candidate IMMUNEPOTENT-CRP. Cell Immunol. 2022 Apr;374:104511. doi: 10.1016/j.cellimm.2022.104511. Epub 2022 Mar 26.
- Background Rivera-Lazarin AL, Martinez-Torres AC, de la Hoz-Camacho R, Guzman-Aguillon OL, Franco-Molinaa MA, Rodriguez-Padilla C. The bovine dialyzable leukocyte extract, immunepotent CRP, synergically enhances cyclophosphamide-induced breast cancer cell death, through a caspase-independent mechanism. EXCLI J. 2023 Jan 13;22:131-145. doi: 10.17179/excli2022-5389. eCollection 2023.
- Background Rivera-Lazarin AL, Calvillo-Rodriguez KM, Izaguirre-Rodriguez M, Vazquez-Guillen JM, Martinez-Torres AC, Rodriguez-Padilla C. Synergistic Enhancement of Chemotherapy-Induced Cell Death and Antitumor Efficacy against Tumoral T-Cell Lymphoblasts by IMMUNEPOTENT CRP. Int J Mol Sci. 2024 Jul 20;25(14):7938. doi: 10.3390/ijms25147938.
- Background Lara HH, Turrent LI, Garza-Trevino EN, Tamez-Guerra R, Rodriguez-Padilla C. Clinical and immunological assessment in breast cancer patients receiving anticancer therapy and bovine dialyzable leukocyte extract as an adjuvant. Exp Ther Med. 2010 May;1(3):425-431. doi: 10.3892/etm_00000066. Epub 2010 May 1.
- Background Franco-Molina MA, Mendoza-Gamboa E, Castillo-Tello P, Isaza-Brando CE, Garcia ME, Castillo-Leon L, Tamez-Guerra RS, Rodriguez-Padilla C. Bovine dialyzable leukocyte extract modulates cytokines and nitric oxide production in lipopolysaccharide-stimulated human blood cells. Cytotherapy. 2007;9(4):379-85. doi: 10.1080/14653240701320262.
- Background Franco-Molina MA, Mendoza-Gamboa E, Castillo-Leon L, Tamez-Guerra RS, Rodriguez-Padilla C. Bovine dialyzable leukocyte extract modulates the nitric oxide and pro-inflammatory cytokine production in lipopolysaccharide-stimulated murine peritoneal macrophages in vitro. J Med Food. 2005 Spring;8(1):20-6. doi: 10.1089/jmf.2005.8.20.
- Background Franco-Molina MA, Mendoza-Gamboa E, Zapata-Benavides P, Vera-Garcia ME, Castillo-Tello P, Garcia de la Fuente A, Mendoza RD, Garza RG, Tamez-Guerra RS, Rodriguez-Padilla C. IMMUNEPOTENT CRP (bovine dialyzable leukocyte extract) adjuvant immunotherapy: a phase I study in non-small cell lung cancer patients. Cytotherapy. 2008;10(5):490-6. doi: 10.1080/14653240802165681.
- Background Reyes-Ruiz A, Calvillo-Rodriguez KM, Martinez-Torres AC, Rodriguez-Padilla C. The bovine dialysable leukocyte extract IMMUNEPOTENT CRP induces immunogenic cell death in breast cancer cells leading to long-term antitumour memory. Br J Cancer. 2021 Apr;124(8):1398-1410. doi: 10.1038/s41416-020-01256-y. Epub 2021 Feb 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMMUNEPOTENT-CRP (I-CRP) | Peptide | — | — |