Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379479
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Toni Homberg von Thaden, National Polytechnic Institute, Mexico

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. 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).

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Infection Drug: Dialyzable Leukocyte Extract Drug: Placebo oral Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Clinical Effect of Dialyzable Leukocyte Extracts in Individuals With Acute Respiratory Infection (Suspected or Confirmed Cases of COVID-19) (FUTURE-T)
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Dialyzable Leukocyte Extract

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
Experimental Intervention. Dialyzable Leukocyte Extract
Other Name: Transferon oral

Placebo Comparator: Placebo

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
Placebo
Other Name: Placebo comparator




Primary Outcome Measures :
  1. Change in the score of the "Contingency scale to assess the severity of acute respiratory disease in cases suspected/confirmed by COVID-19" [ Time Frame: 35 days ]
    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.


Secondary Outcome Measures :
  1. Clinical deterioration [ Time Frame: 35 days ]
    Defined as the presence of signs and symptoms related with respiratory alarm symptoms. The respiratory alarm data will be daily evaluated with the patient's diary in the cell app.

  2. Duration of the clinical status [ Time Frame: 35 days ]
    Defined as the number of days with any of the symptoms mentioned in contingency table during the visits and follow-up through the patient's diary in the cell app.


Other Outcome Measures:
  1. Cytokine concentration [ Time Frame: 35 days ]
    Defined as the changes in the total concentration of the serum cytokines IL-6, TNF-α and type I and II Interferons due to DLE treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults who agree to participate and sign informed consent.
  2. Suspected case, according to the operational definition (CONAVE).*
  3. 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).**
  4. The time of acute respiratory symptoms should be no longer than 72h.
  5. Negative to the rapid test for influenza A/B.
  6. 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.

Exclusion Criteria:

  1. Pregnancy.
  2. Evidence of severe acute respiratory infection, even if it meets the criteria for a suspected or confirmed case.
  3. Hepatic insufficiency
  4. Diseases that occur with immunosuppression or therapeutic immunosuppression.
  5. Heart diseases; controlled hypertension is allowed.
  6. Metabolic diseases; controlled diabetes mellitus is allowed.
  7. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379479


Contacts
Layout table for location contacts
Contact: Melissa I Espinosa-Navarro, MD +525557296000 ext 62369 melissa.espinosa@useic.com.mx
Contact: Maricarmen Sánchez-Leon, MD +525557296000 ext 62531 maria.sanchez@useic.com.mx

Locations
Layout table for location information
Mexico
Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional
Mexico City, Mexico, 11 340
Contact: Melissa I Espinosa-Navarro, MD    +525557296000 ext 62359    melissa.espinosa@useic.com.mx   
Contact: Maricarmen Sánchez-León, MD    +525557296000 ext 52531    maria.sanchez@useic.com.mx   
Principal Investigator: Toni A Homberg, MD         
Sponsors and Collaborators
National Polytechnic Institute, Mexico
Investigators
Layout table for investigator information
Study Director: Sonia Mayra Pérez-Tapia, PhD Instituto Politecnico Nacional
Study Director: Maria C Jimenez-Martínez, MD PhD Universidad Nacional Autonoma de Mexico
Principal Investigator: Toni A Homberg von Thaden, MD National Polytechnic Institute, Mexico
Additional Information:
Publications:
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.

Layout table for additonal information
Responsible Party: Toni Homberg von Thaden, Principal Investigator, National Polytechnic Institute, Mexico
ClinicalTrials.gov Identifier: NCT04379479    
Other Study ID Numbers: IC-20-001
SH-001-2020 ( Other Identifier: Instituto Politécnico Nacional )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be shared that underlies results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toni Homberg von Thaden, National Polytechnic Institute, Mexico:
Dialyzable leukocyte extract
Treatment COVID-19
Treatment SARS-CoV-2 infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection