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

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ClinicalTrials.gov Identifier: NCT04568863
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Hospital Universitario La Paz
Instituto de Investigación Hospital Universitario La Paz
Information provided by (Responsible Party):
Pharmamel S.L.

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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Coronavirus Infection Drug: Melatonin intravenous Drug: Placebo intravenous Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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
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)
Actual Study Start Date : June 20, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
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.
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.

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




Primary Outcome Measures :
  1. Mortality [ Time Frame: one month ]
    Mortality in each study group represented in frequency and time-to-event at day 28 after randomization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568863


Contacts
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Contact: Germaine Escames, PhD +34950241000 ext 20363 gescames@ugr.es

Locations
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Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Germaine Escames, PhD    +34958241000 ext 20363    gescames@ugr.es   
Contact: Darío Acuña-Castroviejo, PhD    +34958241000 ext 20169    dacuna@ugr.es   
Principal Investigator: Juan C Figueira, PhD         
Sub-Investigator: Pedro C de la Oliva, PhD         
Sub-Investigator: Cristina Arévalo Martín, PhD         
Sub-Investigator: Claudio Gutiérrez Mavarez, PhD         
Sub-Investigator: Andoni García Muñoz, PhD         
Sub-Investigator: Alberto Borovia, PhD         
Sub-Investigator: Irene García García, PhD         
Sub-Investigator: Miguel Rodríguez Rubio, PhD         
Sub-Investigator: José M Añón, PhD         
Sub-Investigator: José R Arribas, PhD         
Sub-Investigator: Julio García Rodríguez, PhD         
Sub-Investigator: Darío Acuña-Castroviejo, PhD         
Sub-Investigator: Germaine Escames, PhD         
Sponsors and Collaborators
Pharmamel S.L.
Hospital Universitario La Paz
Instituto de Investigación Hospital Universitario La Paz
Publications:
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Responsible Party: Pharmamel S.L.
ClinicalTrials.gov Identifier: NCT04568863    
Other Study ID Numbers: PHM-2020-001
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pharmamel S.L.:
Melatonin intravenous
Placebo intravenous
ICU patients
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants