Melatonin, the well-known “hormone of darkness” that induces sleep, It is also a powerful anti-inflammatory and antioxidant that may help prevent infection by SARS-CoV-2 and to treat severe cases of covid-19.
This is what two clinical trials led by the La Paz University Hospital in Madrid are trying to prove.
The antioxidant properties of this hormone have already been postulated as a treatment against other coronaviruses, such as SARS-COV-1 or MERS, in studies with animal models “that support it,” the coordinator of the Central Clinical Research Unit explains to EFE. and Clinical Trials (UCICEC) of the Hospital de La Paz, Dr. Alberto Borobia.
Further, melatonin has been part of the cocktail of drugs with which the president of the United States has been treated, Donald Trump, when he suffered from covid-19, although it is difficult to know in what proportion it contributed to his rapid recovery.
What science shows us is that it is a hormone that the body begins to release when the darkness of night arrives and travels through the blood circuit to synchronize the functions of our biological clock.
But like other hormones, su production declines with age, starting at 35 or 40 years, and this affects sleep, inflammatory diseases and even aging, according to data from the International Institute of Melatonin of the University of Granada.
One of the working hypotheses is to check whether reinforcing endogenous melatonin can help prevent SARS-CoV-2 infection in healthy people at high risk of infection.
It is It is the starting point of a clinical trial that you want to test in 450 toilets from different hospitals Spaniards if melatonin prevents infection or, in the event that it is contracted, prevents the development of a serious form of covid-19.
A first wave of the study has already been carried out with 350 volunteers and the second wave is now underway with another hundred more, so efficacy results are expected by early 2021, according to researcher Alberto Borobia.
It is a randomized study in which one group receives an already marketed melatonin drug (2-milligram oral Circadin indicated for insomnia) and the other group, a placebo.
As it is a replacement for a drug already on the market, safety is already evaluated at a dose of 2 milligrams and for 3 months, which is the dose and schedule indicated for insomnia.
“If another dose had been used, it would have been necessary to start at an earlier stage in the development of a new drug“says Dr. Borobia.
During this first wave, some cases of SARS-CoV-2 infection have been detected among the volunteers, but since it was a “double-blind and masked” study until the end, it is not known whether they correspond to the melatonin group or the placebo group.
This trial is challenging by doing without any funding. “Researchers are promoting it, with the selfless help of the UCICEC staff and with donations of the drugs and the placebo from the Exeltis and Liconsa laboratories “, points out its coordinator.
On the other hand, a second clinical trial, in which the La Paz research unit is also collaborating, focuses on knowing the effect of melatonin in coronavirus patients admitted to the ICU.
These are cases that suffer an exaggerated immune response that triggers hyperinflammation in their body and the outcome is the result of multi-organ failure due to sepsis (generalized infection).
“We want to know if, when melatonin is administered in high doses, with anti-inflammatory and antioxidant properties, there could be an immunomodulatory effect“, Borobia needs.
Phase II of this study with 18 patients has just finished, in which the safety has been evaluated: 12 have received a melatonin drug and another 6 a placebo.
The dose is 5 milligrams per kilo of weight, up to a maximum of 500 milligrams a day divided into four doses of intravenous melatonin.
“In this case It is not a question of repositioning a drug but of a new formulation with doses not evaluated previously, so clinical trials in phases II and III are required “, clarifies the coordinator of the UCICEC.
The design of phase III (the last of a clinical trial) has already begun, where the efficacy will be evaluated in some 200 or 300 patients from different Spanish hospitals and it may be that, in addition to critics, it will be extended to moderate patients admitted to the ward in order to avoid their passage to the ICU.
The drug is a patent for intravenous melatonin from the University of Granada and the Andalusian Health Service, which is licensed to the biotechnology company Pharmamel SL.
About three years ago it was carried out in a phase II clinical trial with this drug in patients with sepsis and the result was that those treated with intravenous melatonin not only reduced hospital stay by 40%, but mortality was zero.
Darío Acuña, a pioneer in the study of melatonin in Spain and director of the International Institute of Melatonin based in Granada, explains this to EFE.
When they were preparing phase III of this sepsis melatonin trial, the coronavirus pandemic began and it was observed that severe cases died of generalized infection.
The study was redirected and work began with the Hospital de La Paz to corroborate whether the good results of melatonin in sepsis are also good in covid patients with this generalized infection.
If melatonin is preventive and / or contributes to combat covid-19 is something that science will be able to determine in the coming monthsBut that does not mean that melatonin supplements for insomnia from pharmacies have protective effects against the coronavirus.
This is something that science has not evidenced.
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