Can medicinal cannabis play a role in the fight against COVID-19? That’s the hypothesis behind a new clinical trial set to begin in January 2022. More specifically, the study — being conducted by InCor, the Heart Institute of the São Paulo University Medical School — will test the efficacy of pharmaceutical-grade CBD (a non-psychoactive substance derived from cannabis) in improving the quality of life for people suffering from long-haul COVID symptoms.
As if contracting COVID-19 isn’t horrific enough, studies indicate that more than half (54%) of the patients who survived still experience at least one symptom six months or more after their initial diagnosis. A comprehensive survey, published in the Journal of the American Medical Association, reflects the results from 57 studies of more than 250,000 COVID-19 survivors.
This condition, known variously as post-acute COVID-19, long COVID or long-haul COVID syndrome, carries with it a daunting list of potentially debilitating symptoms including anxiety, cardiac complications, depression, difficulty breathing, fatigue, sleep disorders and short-term memory loss — often described as “brain fog” — to name but a few.
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Here’s the kicker. Long-haul COVID symptoms can affect anyone who has been infected by COVID-19, even when their cases were mild, or they were initially asymptomatic.
COVID-19 has not been kind to Brazil, to say the least. This month, the number of cases hit 22,094,459. Globally, the U.S. and India rank first and second, respectively, followed by Brazil in terms of the countries that have fared the worst. It’s a dubious “honor” at best.
A quick crunch of the numbers indicates that nearly 12 million Brazilians will likely suffer from symptoms associated with long-haul COVID syndrome. As more variants appear — like Omicron, with three cases already confirmed in Brazil — those numbers of people impacted could climb dramatically.
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As a result of the ongoing pandemic, Brazil’s jobless rate hit an all-time high (14.7%) in March 2021. A significant population experiencing prolonged symptoms of long-haul COVID syndrome could further threaten the recovery of a severely weakened economy that entered a “technical recession” on December 2 after a Central Bank report found that Brazil’s GDP shrank 0.1 percent during Q3-2021.
Ready to hear some potentially better news? Depending on the results of the clinical trial, relief for COVID-19 long haulers may soon be visible on the horizon.
New clinical study to test Verdemed CBD in early 2022
Nothing about medicinal cannabis in Brazil is simple. But to better understand the clinical study, it helps to have a bit of background — so here goes:
Brazil maintains stringent guidelines to regulate medicinal-cannabis products, all of which must receive a seal of approval from ANVISA, the country’s national health regulatory agency, which is the equivalent of the United States’ Food and Drug Administration (FDA). One of those requirements: before a company can make any medical claim, it must provide clinical data indicating the efficacy of a cannabis-based pharmaceutical.
Verdemed is pharmaceutical cannabis company founded by Brazilians and headquartered in Toronto, Canada. It owns a subsidiary, Verdemed Farmacêutica Ltda., based in Brazil. Clever Leaves, one of Verdemed’s many suppliers, is a multinational, licensed producer of pharmaceutical-grade cannabinoids, developed and processed from its cannabis cultivation and laboratories in Colombia.
Through its Brazilian subsidiary, Verdemed registered a full-spectrum, pharmaceutical-grade CBD extract — developed by Clever Leaves — with ANVISA. Why? Only Brazilian pharma companies can register cannabis-based products in Brazil. The InCor clinical trial will test a 50-milligram per milliliter version of this potentially valuable CBD product.
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The 2019 Brazilian Cannabis Act (RDC 327) forms the regulatory framework for cannabis-derived medicines produced under the same strict pharmaceutical standards of any other drug. This, according to Jose Bacellar, president and CEO of Verdemed, makes the pharmaceutical-grade designation essential.
Adhering to pharmaceutical-grade manufacturing processes means our medicinal-cannabis formulation is consistent, and each prescription remains stable for 18 months. Patients receive the same intrinsic quality found in any pharmaceutical-grade product.
Jose Bacellar, president and CEO of Verdemed
Cannabis on clinical trial
Dr. Edimar Bocchi, director of the Heart Failure and Mechanical Devices for Cardiac Insufficiency Nucleus at InCor, will lead the double-blind clinical trial. Over a three-month period, 290 patients will take either a placebo or the CBD extract.
“The objective of the study is to test the hypothesis that cannabidiol can improve the quality of life of patients with long-haul COVID syndrome compared with a 100 mg placebo twice a day,” said Bocchi. “Also, to evaluate the effect of cannabidiol on improving specific symptoms or signs of disease consequent to COVID-19 at three months treatment compared to the placebo.”
While long-haul COVID syndrome is still new, the data about it is both significant and alarming.
Based on epidemiological data, it has been proposed that long-haul COVID syndrome will be the next public-health disaster. Although data is still emerging, the average age of patients with long-haul COVID is about 40, which means the majority of those affected are in their prime working years and face economic consequences.
Edimar Bocchi, director of the Heart Failure and Mechanical Devices for Cardiac Insufficiency Nucleus at InCor
By April next year, both Bacellar and Bocchi expect to know — one way or the other — whether Verdemed’s medicinal cannabis improves the quality of life for people with long-haul COVID syndrome.
“This is a very important study, because CBD has never been tested for this purpose.” said Bacellar. “First, we must prove efficacy.”
If they do prove it, Bacellar will submit the findings to ANVISA for scrutiny. The Brazilian public-health agency could ask for further study before validating the Phase 3 trial results.
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If ANVISA agrees that the clinical trial successfully proves efficacy, Bacellar said the agency will most certainly demand a Phase 4 clinical trial involving 1,000 patients. Concurrently, Dr. Bocchi would take on the academic work of publishing the study in a medical journal for peer review.
However, the Phase 3 clinical trial would have proved efficacy, which would leave Verdemed free to make a medical claim for the product.
“If we can prove efficacy — that our CBD improves the quality of life for people with long-haul COVID syndrome — then I have a moral obligation to tell people to discuss it with their doctor, because it can help them,” said Bacellar.
