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New research suggests that melatonin may protect against COVID-19 by increasing tolerance to the virus. But randomized controlled trials are needed before we’ll know if it works. ozgurdonmaz / Getty Images
  • Through a “big data” approach, Cleveland Clinic researchers have identified the sleep aid melatonin as a potential treatment for COVID-19.
  • Melatonin could possibly protect against COVID-19 by increasing tolerance to the virus.
  • Randomized controlled trials are needed before we’ll know if it works.

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As the COVID-19 pandemic continues to surge, there’s a strong push to develop drugs and vaccines that will help control this disease.

According to Feixiong Cheng, PhD, a researcher at Cleveland Clinic’s Lerner Research Institute, one way that researchers have tried to fast-track potential treatments is by repurposing existing drugs.

Some examples of repurposed drugs already in use in the battle against COVID-19 include the steroid dexamethasone and the antiviral remdesivir.

“Traditional de novo [new] drug discovery is costly, and we have to wait a long time (10 to 15 years),” said Cheng. “Drug repurposing will significantly reduce cost and time for the emerging COVID-19 pandemic compared to traditional drug discovery approaches.”

One promising drug that Cheng’s team has identified is something that might already be in your medicine cabinet: the sleep aid melatonin.

According to Dr. Sanjay Sethi, who’s currently studying melatonin as a potential COVID-19 treatment at the University at Buffalo, a “big data” approach uses “large volumes of biological, biometric, and electronic health data for research.”

“It often requires special analytic tools and computing power to complete,” Sethi explained.

Cheng said that his team used network medicine methodologies as well as a large database of electronic health records from the Cleveland Clinic to identify symptoms and processes that COVID-19 has in common with other diseases.

They then obtained the host proteins that are targeted by human coronaviruses or are involved in critical pathways of the infection. These were compared to known drug-to-target interactions.

Based on their analyses, melatonin was identified as a potential treatment for COVID-19.

Sethi said that Cheng’s team had two lines of data that formed the basis of their assessment.

First, from their network analysis, they could see that there were pathways active in COVID-19 that could be affected by melatonin.

Second, they were able to determine that people who got tested for COVID-19 at the clinic who were also taking melatonin had a lower incidence of being positive for the disease.

Cheng said that melatonin might potentially help us by protecting us against the SAR-CoV-2 virus.

“Melatonin may not directly promote the host defense system against the virus but increase the tolerance of the host to the virus,” Cheng explained. “In other words, in some aspect, to reduce the host defense system, for example, reducing the innate immune response and inflammatory reactions of the host.

“Increase in the tolerance of the host to the virus will reduce the tissue and organ damage of the host and allow the host to survive sufficiently long to develop adaptive immune response, particularly the specific antibody, and finally kill or help clean the virus from [the] body.

“There are many possible mechanisms of melatonin in treating COVID-19,” added Cheng, “and our group is actively investigating it using cell-based and pre-clinical models.”

Although melatonin holds promise as a treatment for COVID-19, Cheng’s research is only the beginning.

Cheng said that what’s needed next are randomized controlled trials where melatonin is compared to an inactive placebo to determine the treatment effects as well as an effective dose.

Cheng noted that there are currently seven trials underway with the Cleveland Clinic. Among these trials is also one that Sethi’s team is involved in.

“We are conducting one such pilot study in which we would be enrolling 30 patients with mild to moderate COVID, of which 20 will receive melatonin and 10 will receive placebo,” said Sethi. “This is a double-blinded study.”

In a double-blinded study, neither the study participant nor the experimenter knows who’s receiving the active treatment or placebo.

“If this supports the safety of melatonin in COVID, larger studies will be required to show its efficacy,” Sethi explained.

He cautioned, however, that many promising drugs have shown mixed results in randomized controlled trials.

“Ultimately, the proof is in the pudding,” said Sethi, “and it has to show benefit in properly conducted trials before it is added to our treatment arsenal for COVID.

“It would be a welcome addition if it turns out to be safe and effective because it is inexpensive and widely available.”