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

NCT ID: NCT04568863

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-20
• Study Completion Date: 2020-11-30

Brief 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.

Detailed Description

ICU COVID-19 patients show high risk of death mainly due to sepsis and respiratory disfunction. Prevention of these critical conditions is mandatory to reduce mortality and to improve patient's outcome.

Melatonin is an endogenous hormone involved not only in circadian rhythm control, but also in the cell protection due to its outstanding anti-inflammatory and antioxidative effects. High doses of melatonin have shown high efficacy against bacterial (sepsis) and viral infections. Melatonin is a safe product that consistently has shown lack of side-effects when it is administered to humans.

SARS-CoV 2 infection may yield severe forms of the disease that require the patients admission to the ICU. These patients may develop an excessive inflammatory response and a burst of free radicals, constituting the major cause of death in these subjects.

Our hypothesis is that high doses of melatonin intravenously administered to COVID-19 ICU patients might reach enough blood levels able to prevent/counteract the developing of sepsis and the production of free radicals, reducing mortality and hospital stay.

Conditions

COVID-19; SARS-CoV 2; Coronavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Melatonin

(12 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day.

Group Type: EXPERIMENTAL

Melatonin intravenous

Intervention Type: DRUG

7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day.

Placebo

(6 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.

Group Type: PLACEBO_COMPARATOR

Placebo intravenous

Intervention Type: DRUG

7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.

Interventions

Melatonin intravenous

7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day.

Intervention Type: DRUG

Placebo intravenous

7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Paz

OTHER

Sponsor Role: collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: collaborator

Pharmamel S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario La Paz

Madrid, , Spain

Countries

Spain

References

Rodriguez-Rubio M, Figueira JC, Acuna-Castroviejo D, Borobia AM, Escames G, de la Oliva P. A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Aug 5;21(1):699. doi: 10.1186/s13063-020-04632-4.

Reference Type: BACKGROUND

PMID: 32758298 (View on PubMed)

Acuna-Castroviejo D, Escames G, Figueira JC, de la Oliva P, Borobia AM, Acuna-Fernandez C. Clinical trial to test the efficacy of melatonin in COVID-19. J Pineal Res. 2020 Oct;69(3):e12683. doi: 10.1111/jpi.12683. Epub 2020 Aug 8.

Reference Type: BACKGROUND

PMID: 32770854 (View on PubMed)

Other Identifiers

PHM-2020-001

Identifier Type: -

Identifier Source: org_study_id