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
18 patient melatonin late treatment RCT with results not reported over 2.5 years after completion.
3 melatonin RCTs have results missing long after expected
Boukef, Piovezan, Rodríguez-RubioThe trials report a total of 268 patients, with 2 trials having actual enrollment of 168, and the other estimated.
Rodríguez-Rubio et al., 5 Aug 2020, Double Blind Randomized Controlled Trial, placebo-controlled, Spain, trial
NCT04568863 (history) (MELCOVID).
Contact:
gescames@ugr.es (corresponding author), pedro.oliva@salud.madrid.org.
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
Miguel Rodríguez-Rubio, Juan Carlos Figueira, Darío Acuña-Castroviejo, Alberto M Borobia, Germaine Escames, Pedro De La Oliva
Trials, doi:10.1186/s13063-020-04632-4
Objectives: • Primary objective: to evaluate the effect of intravenous melatonin (IVM) on mortality in adult patients admitted to the intensive care unit (ICU) with COVID-19.
• Secondary objectives: • To evaluate the effect of IVM on ICU length of stay. • To evaluate the effect of IVM on the length of mechanical ventilation (MV). • To evaluate if the use of IVM is associated with an increase in the number of ventilator-free days. • To evaluate if the use of IVM is associated with a reduced number of failing organs as determined by the sequential organ failure assessment (SOFA) scale. • To evaluate if the use of IVM is associated with a reduction of the frequency and severity of COVID-19-associated thromboembolic phenomena. • To evaluate if the use of IVM is associated with a decreased systemic inflammatory response assessed by plasma
Numbers to be randomized (sample size): A total of 18 patients will be randomized in this trial: 12 to the experimental arm and 6 to the control arm. Trial Status: Protocol version 2.0, June 5 th 2020. Trial status: recruitment not started. The first patient is expected to be recruited in October 2020. The last patient is anticipated to be recruited in August 2021. Trial registration: EU Clinical Trials Register. Date of trial registration: 10 July 2020. URL: https://www. clinicaltrialsregister.eu/ctr-search/trial/2020-001808-42/ES Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Keywords: COVID-19, Randomized Controlled Trial, protocol, melatonin, treatment, intensive care, ARDS, inflammation
Supplementary information Supplementary information accompanies this paper at https://doi.org/10. 1186/s13063-020-04632-4. Additional file 1. Full Study Protocol.
Authors' contributions Clinical trial design: JCF, DAC, AMB, GE, PdlO. Recruitment: JCF. Writing of the manuscript: MRR, JCF, DAC, AMB, GE, PdlO. Clinical Trial Coordination: JFC, AMB, PdlO. The authors read and approved the final manuscript.
Funding The start-up Pharmamel LTD financed the trial. The funding body had no role on the design of the study or the collection,..
