COVID-19 infection MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: melatonina 6mg/ml
Product Code: melatonina 6mg/ml
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Melatonin
CAS Number: 73-31-4
Current Sponsor code: Melatonin
Sponsors
Pharmamel S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Granting of informed consent by the patient, their family member or their legal representative. • Age equal to or greater than 18 years. • Presence of SARS-CoV-2 infection, with compatible symptoms and confirmation by PCR. • Admission to the ICU with acute hypoxemic respiratory failure attributed to SARS-CoV-2 infection • Have been admitted to the ICU for less than 7 days, with or without mechanical ventilation (MV) and with no signs of improvement in respiratory failure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: • Be included in another COVID-19 study that involves the administration of a drug in clinical development phase that lacks a prior marketing authorization. • Liver transaminases> 5 times the ULN. • Stage IV or dialysis kidney failure (GFR <30) • Pregnancy • Terminal medical or surgical illness. • Autoimmune disease. • Any condition of the patient that, in the opinion of the investigator, prevents the study procedures from being carried out.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess whether treatment with melatonin i.v. reduces mortality;Secondary Objective: Assess whether melatonin treatment i.v .: - reduces the duration of admission to the ICU - reduces the duration of mechanical ventilation (VM). - It is associated with an increase in VM free days. - is associated with a reduction in the number of vital organ failures, according to the SOFA scale. -is associated with a reduction in frequency and severity of thromboembolic processes caused by COVID-19. - it is associated with a reduction in the systemic inflammatory response, defined by the levels of ferritin, D-dimer, C-reactive protein (PCR) or procalcitonin (PCT) and IL-6. - is associated with improvement of hematological, biochemical, gasometric parameters. Describe the events and adverse reactions that occurred during the study.;Primary end point(s): Mortality in each treatment group, in frequencies and in time until the event.;Timepoint(s) of evaluation of this end point: Mortality in each treatment group, in frequencies and in time until the event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ICU admission time, time with mechanical ventilation and modification of the patient's state of severity with respect to baseline values;Timepoint(s) of evaluation of this end point: ICU admission time, time with mechanical ventilation and modification of the patient's state of severity with respect to baseline values | — |
Countries
Spain
Contacts
Public ContactCatedrática de Fisiología
Centro de Investigación Biomédica Universidad de Granada
Outcome results
None listed