PHASE II CLINICAL TRIAL, SINGLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED TO EXPLORE THE EFFECTIVENESS AND SAFETY OF MELATONIN IN PATIENTS WITH COVID-19 ENTERED INTO THE INTENSIVE CARE UNIT
- Conditions
- COVID-19 infectionMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001808-42-ES
- Lead Sponsor
- Pharmamel S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
• 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method