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

Primary Purpose

COVID-19, SARS-CoV 2, Coronavirus Infection

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Melatonin intravenous
Placebo intravenous
Sponsored by
Pharmamel S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Melatonin intravenous, Placebo intravenous, ICU patients, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

(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.

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

Outcomes

Primary Outcome Measures

Mortality
Mortality in each study group represented in frequency and time-to-event at day 28 after randomization

Secondary Outcome Measures

Full Information

First Posted
September 28, 2020
Last Updated
March 17, 2021
Sponsor
Pharmamel S.L.
Collaborators
Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT04568863
Brief Title
Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19
Acronym
MELCOVID
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmamel S.L.
Collaborators
Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV 2, Coronavirus Infection
Keywords
Melatonin intravenous, Placebo intravenous, ICU patients, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
phase II, single-center, double-blind, randomized placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
(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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
(6 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.
Intervention Type
Drug
Intervention Name(s)
Melatonin intravenous
Intervention Description
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
Intervention Name(s)
Placebo intravenous
Intervention Description
7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality in each study group represented in frequency and time-to-event at day 28 after randomization
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32758298
Citation
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.
Results Reference
background
PubMed Identifier
32770854
Citation
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.
Results Reference
background

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

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