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

NCT04379479 | Unknown Phase 2 DMC

• 2 other identifiers: IC-20-001SH-001-2020
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate clinical deterioration and respiratory alarm data.
2. 2.To evaluate the duration of the clinical picture.
3. 3.To explore cytokine changes associated with the therapeutic effect induced by DLE.
4. 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. 5.To generate information to validate the contingency scale to assess the severity of acute respiratory disease (suspected/confirmed cases of COVID-19).
6. 6.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).
7. 7.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).
8. 8.The addition of DLE to the symptomatic treatment could decrease the duration of the clinical outcome (suspected/confirmed cases of COVID-19).

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

Dialyzable leukocyte extract; Treatment COVID-19; Treatment SARS-CoV-2 infection

Outcome Measures

Primary Outcomes (1)

• Change in the score of the "Contingency scale to assess the severity of acute respiratory disease in cases suspected/confirmed by COVID-19"

  Change in the score of the "Contingency scale to assess the severity of acute respiratory disease in cases suspected/confirmed by COVID-19" at the end of treatment concerning the baseline value. The clinical effect will be daily evaluated with the patient's diary in the cell app. Minimum value 0, Maximum value 32 points. Higher scores mean worse outcome.

  35 days

Secondary Outcomes (2)

• Clinical deterioration

  35 days

• Duration of the clinical status

  35 days

Other Outcomes (1)

• Cytokine concentration

  35 days

Study Arms (2)

Dialyzable Leukocyte Extract

EXPERIMENTAL

Oral administration 2 mg/5 mL every 24 hours for 14 days, following by 2 mg/5 mL twice a week for 3 weeks. All patients will receive paracetamol as symptomatic treatment, 500 mg oral administration 3 times per day.

Drug: Dialyzable Leukocyte Extract

Placebo

PLACEBO COMPARATOR

Oral administration 5 mL every 24 hours for 14 days, following by 5 mL twice a week for 3 weeks. All patients will receive paracetamol as symptomatic treatment, 500 mg oral administration 3 times per day.

Drug: Placebo oral

Interventions

Dialyzable Leukocyte Extract DRUG

Experimental Intervention. Dialyzable Leukocyte Extract

Also known as: Transferon oral

Dialyzable Leukocyte Extract

Placebo oral DRUG

Placebo

Also known as: Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who agree to participate and sign informed consent.
• Suspected case, according to the operational definition (CONAVE).\*
• In the case of confirmed cases, will be those individuals who meet the operational definition of a suspected case and have a confirmed diagnosis by molecular biology, according to the operational definition (CONAVE).\*\*
• The time of acute respiratory symptoms should be no longer than 72h.
• Negative to the rapid test for influenza A/B.
• Live in an urban area with easy access for visits.
• Person of any age that has presented at least two of the following signs and symptoms: cough, fever or headache
• Accompanied by at least one of the following signs or symptoms:
• Dyspnea (signal of severity) Arthralgia Myalgia Odynophagia / pharyngeal burning Rhinorrhea Conjunctivitis Chest pain
• \*\*SARS-CoV2 infection confirmed by molecular diagnostic by one laboratory from the National Network of Public Health Laboratories recognized by InDRE.

You may not qualify if:

• Pregnancy.
• Evidence of severe acute respiratory infection, even if it meets the criteria for a suspected or confirmed case.
• Hepatic insufficiency
• Diseases that occur with immunosuppression or therapeutic immunosuppression.
• Heart diseases; controlled hypertension is allowed.
• Metabolic diseases; controlled diabetes mellitus is allowed.
• Individuals who have been treated with DLE in the last 6 months.
• CONAVE: National Committee for Epidemiological Surveillance. InDRE: Institute of Epidemiological Diagnosis and Reference.

Sponsors & Collaborators

• National Polytechnic Institute, Mexico: lead

Study Sites (1)

Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional

Mexico City, 11 340, Mexico

Location

Related Publications (7)

• 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.

  PMID: 31547184 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.

  PMID: 28707490 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.

  PMID: 27847830 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.

  PMID: 27525277 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.

  PMID: 25984538 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.

  PMID: 24099727 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.

  BACKGROUND

Related Links

• Official site

MeSH Terms

Conditions

COVID-19

Interventions

Transfer Factor

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Lymphokines; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Sonia Mayra Pérez-Tapia, PhD

  Instituto Politecnico Nacional

  STUDY DIRECTOR

• Maria C Jimenez-Martínez, MD PhD

  Universidad Nacional Autonoma de Mexico

  STUDY DIRECTOR

• Toni A Homberg von Thaden, MD

  National Polytechnic Institute, Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa I Espinosa-Navarro, MD

CONTACT

+525557296000; melissa.espinosa@useic.com.mx

Maricarmen Sánchez-Leon, MD

CONTACT

+525557296000; maria.sanchez@useic.com.mx

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Exploratory clinical trial, prospective, longitudinal, placebo-controlled, double-blinded, in patients with symptoms of non-severe acute respiratory infection (suspected/confirmed cases of COVID-19).

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 7, 2020
• Study Start: May 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available immediately at the end of study.
• Access Criteria: All data will be published in a scientific journal.

Locations

ME (1)