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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568863
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : March 18, 2021
Sponsor:
Collaborators:
Hospital Universitario La Paz
Instituto de Investigación Hospital Universitario La Paz
Information provided by (Responsible Party):
Pharmamel S.L.

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE September 29, 2020
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE June 20, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
Mortality [ Time Frame: one month ]
Mortality in each study group represented in frequency and time-to-event at day 28 after randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
phase II, single-center, double-blind, randomized placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • SARS-CoV 2
  • Coronavirus Infection
Intervention  ICMJE
  • Drug: 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.
  • Drug: Placebo intravenous
    7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Melatonin intravenous
  • Placebo Comparator: Placebo
    (6 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.
    Intervention: Drug: Placebo intravenous
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2020)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04568863
Other Study ID Numbers  ICMJE PHM-2020-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Pharmamel S.L.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pharmamel S.L.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Hospital Universitario La Paz
  • Instituto de Investigación Hospital Universitario La Paz
Investigators  ICMJE Not Provided
PRS Account Pharmamel S.L.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP