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

NCT04568863 | Completed Phase 2 DMC

• 1 other identifier: PHM-2020-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV 2; Coronavirus Infection

Keywords

Melatonin intravenous; Placebo intravenous; ICU patients; COVID-19

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  one month

Study Arms (2)

Melatonin

EXPERIMENTAL

(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

Placebo

PLACEBO COMPARATOR

(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

Interventions

Melatonin intravenous 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.

Melatonin

Placebo intravenous DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pharmamel S.L.: lead
• Hospital Universitario La Paz: collaborator
• Instituto de Investigación Hospital Universitario La Paz: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (2)

• 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.

  PMID: 32758298 BACKGROUND

• 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.

  PMID: 32770854 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: phase II, single-center, double-blind, randomized placebo-controlled trial

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: September 29, 2020
• Study Start: June 20, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 18, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)