Clinical Effect of Dialyzable Leukocyte Extract in Suspected or Confirmed Cases of COVID-19 (FUTURE-T)

Summary

Main goal: To generate information on the efficacy and safety of Dialyzable Leukocyte Extract (DLE) as an aid in the treatment of patients with acute respiratory infection (suspected or confirmed cases of COVID-19). Primary goal: To generate information on the efficacy of DLE as an aid in symptomatic treatment, by reducing the signs and symptoms of acute respiratory infection (suspected/confirmed cases of COVID-19). Secondary goals: 1. To evaluate clinical deterioration and respiratory alarm data. 2. To evaluate the duration of the clinical picture. 3. To explore cytokine changes associated with the therapeutic effect induced by DLE. 4. To obtain data on the safety of DLE as an aid in the symptomatic treatment of acute respiratory infection (suspected/confirmed cases of COVID-19). 5. To generate information to validate the contingency scale to assess the severity of acute respiratory disease (suspected/confirmed cases of COVID-19). Justification The systemic inflammatory response has been recognized as being responsible for COVID-19 complications. Immunomodulation strategies to control it are currently being considered, including the use of systemic steroids to down-regulate the systemic inflammatory response, the use of human immunoglobulin and even chloroquine given its anti-inflammatory and antiviral qualities; however, none of these treatments has been sufficiently studied or has shown any significant change in the clinical course of infected patients. Due to the importance of the COVID-19 pandemic and in the absence of specific treatment, it is important to implement new treatments that allow modulating the immune response, and one strategy may be the addition of DLE to symptomatic and supportive treatment. Hypotheses by goals. 1. The addition of DLE to the symptomatic treatment could decrease the severity of the clinical outcome (signs and symptoms) in individuals with an acute respiratory infection (cases suspected/confirmed by COVID-19). 2. The addition of DLE to the symptomatic treatment could decrease the clinical deterioration due to the acute respiratory infectious process (suspected/confirmed cases of COVID-19). 3. The addition of DLE to the symptomatic treatment could decrease the duration of the clinical outcome (suspected/confirmed cases of COVID-19).

Timeline

Start

2020-05

Primary completion

2020-08

Completion

2020-12

Publications

• Background Carballo-Uicab G, Linares-Trejo JE, Mellado-Sanchez G, Lopez-Morales CA, Velasco-Velazquez M, Pavon L, Estrada-Parra S, Perez-Tapia SM, Medina-Rivero E. Validation of a Cell Proliferation Assay to Assess the Potency of a Dialyzable Leukocyte Extract Intended for Batch Release. Molecules. 2019 Sep 20;24(19):3426. doi: 10.3390/molecules24193426.
• Background Avila S, Munoz-Garcia L, Vazquez-Leyva S, Salinas-Jazmin N, Medina-Rivero E, Pavon L, Mellado-Sanchez G, Chacon-Salinas R, Estrada-Parra S, Vallejo-Castillo L, Perez-Tapia SM. Transferon, a peptide mixture with immunomodulatory properties is not immunogenic when administered with various adjuvants. J Immunotoxicol. 2017 Dec;14(1):169-177. doi: 10.1080/1547691X.2017.1346009.
• Background Ramirez-Ramirez D, Vadillo E, Arriaga-Pizano LA, Mayani H, Estrada-Parra S, Velasco-Velazquez MA, Perez-Tapia SM, Pelayo R. Early Differentiation of Human CD11c+NK Cells with gammadelta T Cell Activation Properties Is Promoted by Dialyzable Leukocyte Extracts. J Immunol Res. 2016;2016:4097642. doi: 10.1155/2016/4097642. Epub 2016 Oct 25.
• Background Medina-Rivero E, Vallejo-Castillo L, Vazquez-Leyva S, Perez-Sanchez G, Favari L, Velasco-Velazquez M, Estrada-Parra S, Pavon L, Perez-Tapia SM. Physicochemical Characteristics of Transferon Batches. Biomed Res Int. 2016;2016:7935181. doi: 10.1155/2016/7935181. Epub 2016 Jul 20.
• Background Salinas-Jazmin N, Estrada-Parra S, Becerril-Garcia MA, Limon-Flores AY, Vazquez-Leyva S, Medina-Rivero E, Pavon L, Velasco-Velazquez MA, Perez-Tapia SM. Herpes murine model as a biological assay to test dialyzable leukocyte extracts activity. J Immunol Res. 2015;2015:146305. doi: 10.1155/2015/146305. Epub 2015 Apr 23.
• Background Medina-Rivero E, Merchand-Reyes G, Pavon L, Vazquez-Leyva S, Perez-Sanchez G, Salinas-Jazmin N, Estrada-Parra S, Velasco-Velazquez M, Perez-Tapia SM. Batch-to-batch reproducibility of Transferon. J Pharm Biomed Anal. 2014 Jan;88:289-94. doi: 10.1016/j.jpba.2013.09.004. Epub 2013 Sep 17.
• Background Homberg T, Sáenz V, Galicia-Carreón J, Lara I, Cervantes-Trujano E, Andaluz MC, Vera E, Pineda O, Ayala-Balboa J, Estrada-García A, Estrada-Parra S, Pérez-Tapia M, Jiménez-Martínez MC.The adverse event profile in patients treated with Transferon TM (Dialyzable leukocyte extracts): A preliminary report. Pharmacology & Pharmacy. 2015; 6(02): 65.

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