Status:
UNKNOWN
Clinical Effect of Dialyzable Leukocyte Extract in Suspected or Confirmed Cases of COVID-19 (FUTURE-T)
Lead Sponsor:
National Polytechnic Institute, Mexico
Conditions:
COVID-19
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 case...
Detailed Description
Dialyzable Leukocyte Extract (DLE) (Transferon oral®) is a dialyzed extract obtained from human leukocytes. Its active ingredient is a complex mixture of low molecular weight peptides obtained from di...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT04379479
Start Date
May 1 2020
End Date
December 1 2020
Last Update
May 7 2020
Active Locations (1)
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1
Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional
Mexico City, Mexico, 11 340