Clinical Effect of Dialyzable Leukocyte Extract in Suspected or Confirmed Cases of COVID-19 (FUTURE-T)
Status:
Not yet recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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).