Melatonin, the well-known “hormone of darkness” that induces sleep, It is also a powerful anti-inflammatory and antioxidant that can help prevent infection SARS-CoV-2 and for the treatment of severe cases of COVID-19.
This is what two clinical trials conducted by the University Hospital of La Paz in Madrid are trying to prove.
The antioxidant properties of this hormone have already been postulated as a treatment for other coronaviruses, such as SARS-COV-1 or MERS, in animal models that “support this,” explains the coordinator of the Central Clinical Research Unit to EFE. and Clinical Trials (UCICEC) Hospital La Paz, Dr. Alberto Borobia.
Further, melatonin was part of a cocktail of drugs used to treat the president of the United StatesDonald Trump when he was suffering from COVID-19, although it is difficult to say to what extent this contributed to his quick recovery.
Science shows us that this is a hormone that the body begins to release when darkness falls and travels along the bloodstream to synchronize the functions of our biological clock.
But, like other hormones, withu production decreases with age, starting at 35 or 40and it affects sleep, inflammatory diseases and even aging, according to the International Melatonin Institute at the University of Granada.
One working hypothesis is to test whether boosting endogenous melatonin can help prevent SARS-CoV-2 infection in healthy people at high risk of infection.
East This is the starting point for a clinical trial that you want to test in 450 toilets from different hospitals. Spaniards, if melatonin prevents infection or, in case of infection, prevents the development of a serious form of covid-19.
The first wave of the study has already been conducted with 350 volunteers, and the second wave is now under way with a hundred more, so the results on efficacy are expected by early 2021, according to researcher Alberto Borobia.
This is a randomized study in which one group receives an already marketed melatonin drug (2 milligram oral circadin, recommended for the treatment of insomnia) and the other group receives a placebo.
Since this is a replacement for a drug already on the market, safety has already been assessed at a dose of 2 milligrams and over 3 months, which is the dose and schedule indicated for insomnia.
“If a different dose were used, it would have to start at an earlier stage in the development of a new drug.“says Dr. Borobia.
During this first wave, several cases of SARS-CoV-2 infection were found among volunteers, but since this was a “double-blind and disguised” study to the end, it is not known if they fit into the melatonin group or the placebo group.
This trial is difficult to do without any funding. “Researchers are promoting thiswith the selfless help of the UCICEC staff and with donations of medicines and placebos from the Exeltis and Liconsa laboratories, ”notes the coordinator.
On the other hand, the second clinical trial, which is also collaborating with the La Paz research arm, is focused on studying the effects of melatonin on coronavirus patients admitted to the intensive care unit.
These are cases where there is an increased immune response that causes hyperinflammation in their bodies, and as a result, multiple organ failure due to sepsis (generalized infection) occurs.
“We want to know if the administration of high doses of melatonin, with anti-inflammatory and antioxidant properties, can have an immunomodulatory effect.“, – says Boronia.
Phase II of this study with 18 patients has just ended, in which safety was assessed: 12 received melatonin and 6 received placebo.
The dose is 5 milligrams per kilogram of body weight, up to a maximum of 500 milligrams per day, divided into four doses of intravenous melatonin.
“In this case This is not about repositioning the drug, but about a new formulation with as yet unappreciated doses. earlier, which requires clinical trials in phases II and III, ”clarifies the UCICEC coordinator.
A Phase III design (the last of the clinical trials) has already begun, where efficacy will be evaluated in about 200 or 300 patients from various Spanish hospitals, and perhaps, in addition to critics, it will be extended to moderate patients admitted to the ward. to avoid their transfer to the intensive care unit.
The drug is a patent for intravenous melatonin issued by the University of Granada and the Andalusian Health Service. licensed to the biotechnology company Pharmamel SL.
About three years ago, this was done in a second phase of clinical trials of this drug in patients with sepsis, and as a result, patients receiving intravenous melatonin not only reduced hospital stays by 40%, but also reduced mortality.
Dario Acuña, a pioneer in melatonin research in Spain and director of the International Melatonin Institute in Granada, explains this to the EFE.
When they were preparing a Phase III study of melatonin for sepsis, the coronavirus pandemic began, and it was noticed that severe cases died from generalized infection.
The study was redirected and work began with La Paz Hospital to confirm whether good melatonin results are good for sepsis in patients with this generalized infection.
Whether melatonin is preventative and / or contributes to the fight against covid-19 is something that science will be able to determine in the coming months.But that doesn’t mean drug store melatonin supplements for insomnia have a protective effect against coronavirus.
This is what science has not shown.