Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmamel S.L.
• Collaborators: Hospital Universitario La Paz; Instituto de Investigación Hospital Universitario La Paz
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Patient, family member or legal guardian has provided written Informed Consent.

• Age ε 18 years.

• Confirmed SARS-CoV-2 infection with compatible symptoms AND a positive RT-PCR.

• Admission to the ICU with acute hypoxemic respiratory failure attributed to SARS-CoV-2 infection.

• ICU length of stay of less than 7 days prior to randomization with or without MV and without signs of improvement in respiratory failure (MURRAY score at randomization greater or equal to the MURRAY score at ICU admission).

Exclusion Criteria:

• Participant in a different COVID-19 study in which the study drug is under clinical development and hasn't been previously authorized for commercialization.

• Liver enzymes > 5 times the upper normal range.

• Chronic kidney disease with GFR < 30 mL/min/1.73 m2 (stage 4 or greater) or need for hemodialysis.

• Pregnancy. A pregnancy test will be performed on every woman younger than 55 years of age prior to inclusion.

• Terminal surgical or medical illness.

• Autoimmune disease.

• Any patient condition that can prevent the study procedures to be carried out at the treating physician's judgement.