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 : Completed
First Posted : September 29, 2020
Last Update Posted : March 18, 2021
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19 SARS-CoV 2 Coronavirus Infection||Drug: Melatonin intravenous Drug: Placebo intravenous||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|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)|
|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|
|Actual Primary Completion Date :||November 30, 2020|
|Actual Study Completion Date :||November 30, 2020|
(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.
- Mortality [ Time Frame: one month ]Mortality in each study group represented in frequency and time-to-event at day 28 after randomization
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
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
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Responsible Party:||Pharmamel S.L.|
|Other Study ID Numbers:||
|First Posted:||September 29, 2020 Key Record Dates|
|Last Update Posted:||March 18, 2021|
|Last Verified:||September 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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