On the other hand, when dealing with a novel coronavirus, a certain amount of speed and urgency is necessary. Professor Chris Molloy, Chief Executive Officer of the U.K,’s Medicines Discovery Catapult, told BioSpace that real-time data should be considered, with a different lens applied.
Our hopes have been dashed many times by “miracle cures” touted for COVID-19, so on September 25, when President Nicolás Maduro of Venezuela promoted one with no scientific evidence whatsoever to back it up, nobody could blame the research community for being just a bit skeptical.
Of course, we all remember hydroxychloroquine, the anti-malaria drug pushed by former U.S. President Donald Trump as a preventative treatment for COVID-19. This claim has been widely debunked, including by The World Health Organization (WHO). Here is a look at the relative potential of a few other proposed treatments for the novel coronavirus.
Maduro’s “Miracle Cure” of the Month
In October, President Nicolás Maduro let the Pan American Health Organization know that Venezuelan scientists had discovered a molecule that nullifies the replication capacity of SARS-CoV2.
Doctors say that the latest drug Maduro is peddling, Carvativir, is derived from the common garden herb, Thyme.
“Ten drops under the tongue every four hours and the miracle is done. It’s a powerful antiviral, very powerful, that neutralizes the coronavirus,” said Maduro in a televised appearance on Sunday.
The Venezuelan government, however, has provided no scientific proof and credited no scientist with the discovery, so the scientific community remains pretty much in the dark on the reasoning behind Maduro’s claim.
On Monday, Venezuela’s National Academy of Medicine said in a statement that Carvativir “has therapeutic potential against coronavirus. Nonetheless, it is prudent to wait for more data from the Carvativir tests ... to consider it a candidate for an anti-COVID-19 medication.”
Jury Still Out on Ivermectin as a Treatment for COVID-19
Anti-parasite drug, Ivermectin, has been the source of much controversy around the world, specifically in Latin America, as well as France, South Africa, and South Korea during the first few months of the COVID-19 pandemic.
Used to treat head lice, and river blindness in sub-Saharan Africa, Ivermectin was encouraged early on across social media as a treatment for COVID-19, but health authorities have countered that more testing is needed.
The inexpensive drug received rave reviews from governments, such as that of President Jair Bolsonaro, which authorized the drug to treat COVID-19 patients in May of 2020 despite admitting that there was “to date no scientific evidence of a drug treatment for COVID-19.”
Early support for Ivermectin was said to be due to analysis published in April, 2020 on a pre-print server.
“The policy decisions of ivermectin in Latin America have been largely based on the analysis presented in a pre-print in early April,” said experts at the Barcelona Institute for Global Health. The paper was later retracted.
The National Institutes of Health (NIH), which previously recommended against Ivermectin for the treatment of COVID-19, is now leaving the decision up to individual physicians.
According to guidance updated on January 14th, the NIH’s COVID-19 Treatment Guidelines Panel said that “there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19.”
Several physicians, such as Dr. Pierre Kory, president, and co-founder of the Front Line COVID-19 Critical Care Alliance (FLCCC), applauded the decision.
“We are encouraged that the NIH has moved off of its August 27 recommendation against the use of ivermectin,” said Kory, a pulmonologist and ICU specialist. “That recommendation was outdated. It was made just as the numerous compelling studies for ivermectin were starting to roll in.”
The FLCCC was not completely satisfied, however, with the neutral stance taken by the agency.
“Patients do not have time to wait, and we as healthcare providers in society do not have that time either,” the group wrote in a statement.
Perspective:
The FLCCC is not alone in its belief that a certain amount of speed and urgency is necessary. Professor Chris Molloy, Chief Executive Officer of the U.K,’s Medicines Discovery Catapult (MDC), told BioSpace that real-time data should be considered, with a different lens applied.
“There’s also the natural challenge of, is that information correct? Is this real news or fake news? That is a natural consequence of speed. But with the purpose that this COVID has given the entire community, actually, I think the community is comfortable to accept the issues of quality with the importance and the vital nature of speed,” said Molloy. “They’ll apply a different filter given the speed.”
Canada’s Colchicine Study Could Catch On
This different filter may be applied to the data from a study put out on January 22 as a press release by the Montreal Heart Institute (MHI). In the press release, MHI outlined the results of its COLCORONA Study, stating that Colchicine, originally intended to treat or prevent gout, reduced the risk of death or hospitalization in patients with COVID-19 by 21% when compared to a placebo.
MHI called the results of the global study, which consisted of 4488 patients, “clinically persuasive” and said that it approached “statistical significance.”
Colchicine works by reducing the inflammation caused by crystals of uric acid that occur in the joints. It is also indicated for viral pericarditis, coronary disease, and Familial Mediterranean Fever (FMF). Colchicine’s potential value in COVID-19 is against the inflammatory, or Cytokine, storm.
“It’s mechanism of action is through the inhibition of tubulin polymerization, with effects on the inflammasome, cellular adhesion molecules and inflammatory chemokines. In an experimental model of acute respiratory distress syndrome, colchicine was shown to reduce inflammatory lung injury and respiratory failure by interfering with leukocyte activation and recruitment,” said Dr. Andreas Orfanos, Director of The Montreal Health Innovations Coordinating Center (MHICC).
The primary objective of the COLCORONA study was to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19, while the secondary end-point aimed to determine its safety.
Initial doubt from the scientific community stemmed partly from the fact that definitive data was not released on the number of patients who became hospitalized, needed ventilation, or died.
The fact that this data was revealed through a press release, as opposed to in a peer-reviewed medical journal, also brought some skepticism. However, the Colchicine Coronavirus SARS-CoV2 (COLCORONA) trial boasts some impressive collaborators, including the National Heart, Lung, and Blood Institute (NHLBI), the Bill and Melinda Gates Foundation, and the Government of Quebec.
Orfanos told BioSpace that urgency was the driving factor behind the unorthodox publication method.
“We issued a press release on January 22, 2021, because of the importance in our opinion of the COLCORONA results. The scientific journal to which we submitted the full manuscript requested us initially to communicate publicly only a minimal amount of results and without p-values. Because of the requests of multiple governments, the journal editors then allowed us to make public the entire manuscript,” he said.
The preprint manuscript made public on January 27th on Biomedical Archives.
Dexamethasone Recommended on Strength of U.K. RECOVERY Trial
This inexpensive and ubiquitous steroid has been around since the 1960s. With its anti-inflammatory properties, dexamethasone gained a lot of attention early on in the pandemic, but scientists say more investigation is needed.
The hypothesis is that dexamethasone, currently in use to treat asthma, arthritis, multiple sclerosis, and severe allergies, helps to suppress the overblown immune response, or cytokine storm, associated with many of COVID-19’s most deadly symptoms.
Preliminary results announced in June from a RECOVERY trial run by the University of Oxford and including more than 11,500 patients from approximately 175 U.K. hospitals, indicated that the drug might be able to reduce death in ventilated COVID-19 patients by one-third, and by one-fifth for those requiring oxygen.
Based on these results, the National Institutes of Health (NIH) COVID-19 treatment guidelines “recommend the use of dexamethasone in certain people hospitalized with severe COVID-19.”
There is, however, concern in the medical community about the long-term effects of the drug. According to Dr. Jennifer Hanrahan, an infectious disease specialist and associate professor in the College of Medicine and Life Sciences at the University of Toledo, one-third of patients hospitalized with the SARS-CoV-1 during 2003 and 2004 and treated with corticosteroids like dexamethasone, experienced adverse effects such as osteoporosis.
Added Hanrahan, “For some of these patients who are critically ill – who are on ventilators – we are seeing some secondary bacterial infections when they’re in the hospital, so giving corticosteroids also potentially increases the risk of other infections.”
