Doctors are experimenting with a number of drugs around the world off label and through compassionate use to treat coronavirus patients.
Over the longer term, clinical trials will be needed to prove effectiveness and that the side effects are not worse than the disease – or at least for what types of patients the rewards justify the risks. But for critical COVID-19 patients, there is no time right now to wait, nor even for peer review. Keep in mind that for most people, COVID-19’s actual mortality rate looks to be significantly under one percent, but significantly higher and more contagious than seasonal than influenza – skewed much higher to elderly and those with underlying conditions like smoking, hypertension, and diabetes.
Barring a major breakthrough, most experts report a widely available vaccine – several are already in trials – looks to be at least a year away. At the same time, social distancing, testing and tracing continue and become more targeted. And healthy living, eating and exercise seem to greatly reduce the risk and severity of getting sick.
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Hydroxychloroquine (Plaquenil) and chloroquine (Arelene)
Approved by the FDA in 1955, the anti-malarial drug hydroxychloroquine is less toxic than its ancestor chloroquine. Chloroquine was in turn derived from quinine, a substance Incas found in the bark of trees and used to treat malaria going back to the 1600s. In more recent years, hydroxychloroquine has also been used to treat lupus and rheumatoid arthritis. Chinese, Korean, and French doctors have reported success using hydroxychloroquine to treat COVID-19. Major clinical trials are underway in Europe, and it’s being prescribed “off-label” in US. Many of these doctors have been using hydroxychloroquine combined with Azithromycin (Zithromax), an anti-bacterial drug used to fight pneumonia, in 4 to 10-day regimens.
In France, a charismatic long-haired physician, PhD, and lab director from Marseille named Didier Raoult has forcefully advocatedfor hydroxychloroquine’s use against COVID-19 on YouTube and elsewhere. He has reported strong improvement in 78 of 80 hospital patients given the drug. The treatment works best when people were given the antiviral relatively early, said Dr Raoult, who specializes in infectious diseases, meaning before they needed oxygen support.
So has Dr. Stephen Smith, founder of nonprofit Smith Center for Infectious Disease and Urban Healthin New Jersey, who has been treating at least 72 COVID-19 patients. Dr. Smith explains that Body Mass Index (BMI) – obesity, along with diabetes or pre-diabetic conditions, are strong predictors of severe cases of COVID-19. He reports that not a single COVID-19 patient of his that has been on the hydroxychloroquine and azithromycin regimen for five days or more has had to be intubated. He too calls it a “game-changer.” “I think this is the beginning of the end of the pandemic,” he says. “I’m very serious.”
In the US, Dr Raoult’s message about hydroxychloroquine got amplified on Twitter by Tesla billionaire Elon Musk, relayed by pundits on Fox News, and then President Trump. President Trump tweeted that the drug had a “real chance to be one of the biggest game changers in the history of medicine.” That prompted Anthony Fauci, Trump’s best-known health adviser and longtime director of the National Institute for Allergies and Infectious Disease, to warn against getting excited about what he called “anecdotal evidence,” and not assume it’s a “knockout drug.” Dr. Fauci and Thomas Navarro, an administration economic adviser, reportedly had a spirited debateabout the drug’s potential efficacy.
US Department of Health and Human Services (HHS) says there currently are no approved treatments for COVID-19 [it takes many months if not years to go through true clinical trials], but that both drugs have “shown activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19)… Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients,” HHS said in a statement. “Clinical trials are needed to provide scientific evidence that these treatments are effective.”
The drugs are made by Mylan, Novartis, Teva, Sanofi, among others, as it’s now generic and relatively cheap. These companies have already provided at least 29 million doses for the national stockpile in recent weeks, and they’re already being used on thousands of patients. States like Michigan, New York, and Nevada, concerned about hoarders keeping it from chronic patients- and also potentially affected by the partisan reporting on the subject – initially rejected the treatment unless it got approved by now-overwhelmed hospital bureaucracy. These states are now asking the FDA for supplies of the drug so doctors can prescribe them. In New York, the University of Albany’s School of Public Health and New York University’s Langone Medical School, among others, are tracking over 4000 patients who are already receiving it in the state.
Why not just give it to everyone? Hydroxychloroquine does have potentially serious side effects, though less than the earlier chloroquine. They include cardiac arrythmia, and for patients who are not critically ill, the risks may conceivably be higher than the benefits. The most serious – like eye toxicity and heart issues – tend to come with chronic use, not the short duration for malaria or COVID-19. However, medical professionals or others using it as a prophylactic (prevention) could be at greater risk.
Back in January, the World Health Organization suggested remdesiviras the most promising drug to treat COVID-19. It’san anti-viral drug that proved effective against Ebola. Remdesivir inhibits viral replication through premature termination of RNA transcription, according to the CDC and maker Gilead Labs – essentially sabotaging the virus’s genome to prevent replication. Gilead promised to donate 1.5 million doses, or enough to treat 140,000 patients. And more is being manufactured: enough for 500,000 patients by October, 1 million by the end of the year. Right now, it’s being tested at 75 universities.
Over the weekend, among surging demand, limited supplies and data, Gilead asked to limit emergency compassionate use requests for the drug in favor of enrolling in a clinical trial, concerned with limited supply as well as risks vs. rewards. They promised to process existing requests and make exceptions for children and pregnant women.
Leronlimab is a self-injectable treatment currently in clinical trials for HIV and breast cancer. When the virus infects the lungs, a person’s immune system sends chemicals to fight it. But in some patients – usually elderly or unhealthy ones, they over-respond and inflame the lungs, a “cytokine storm” which sometimes proves fatal. Leronlimab counters this storm, “calming” the immunoresponse. Doctors report using it successfullyfor critically ill patients. It’s now in two rushed clinical trials: one for moderately ill COVID-19 patients, and one for severely ill ones.
Vicromax is another orally administered, broad-spectrum antiviral drug, this one from Trek and now BioSig in Connecticut. BioSig reportsthat it’s already gone through clinical trials for other viruses and has shown a 90% reduction in the COVID-19 virus in trials.
Convalescent plasmaand hyperimmune globulin
These treatments rank among the most promisingand have a history of effectiveness going back to the 1918 Flu Pandemic. People who have recovered volunteer to donate blood plasma with their antibodies to those still sick with the virus. Convalescent plasma requires matching blood types, but one donor can help 3-4 patients and donate approximately every 28 days. Mt. Sinai-Icahn in New York City is one of at least 34 institutions participating in the National COVID-19 Convalescent Plasma Project, and the FDA has been working with companies for weeks already.
Hyperimmune globulin involves taking plasma from a lot of patients and then scaling it up through manufacturing. It could be given as a prophylaxis (prevention) – a temporary “vaccine” that could inoculate millions of people until a permanent vaccine is ready.
Dr. Haseltine, who remains highly critical of hydroxychloroquine, believes these treatments provide the most promise, but they will take months, like the next one.
Targeted monoclonal antibodies
“This is the thing that turned the tide against Ebola,” says Distributed Bio CEODr. Jacob Glanville, featured on the documentary Pandemic. “The Ebola used to be a death sentence, about 50 percent mortality rate,” Glanville continues. “And then once a good antibody neutralizing solution was made, then I think 94 percent of people can walk away.”
“We’ve also got antibodies to treat rabies. We’ve got antibodies to treat RSV in babies. Antibodies are used to for anti-venom. So this is extremely well-established platform technology. It has the advantage,” according to Glanville. “You can produce antibodies much faster than you can make a vaccine.”
He hopes to reach human trials this summer.
One such monoclonal antibody comes from Regeneron Pharmaceuticals and Sanofi. It’s reportedly in Phase II/III trials in Italy, Spain, Germany, France, Japan, Canada and Russia. It’s a fully human monoclonal antibody (mAb) that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. This would also “calm” the sometimes-fatal cytokine storm immunoresponse.
COVID-19 novel coronavirus
Vitamin C in large doses
Getting a healthy daily dose of vitamin C is generally recommended to aid the immune system. In a clinical trial underway in China, it’s being given in large doses to severely ill COVID-19 patients. It’s also likely being used elsewhere experimentally.
This is an anti-viral combo used to treat HIV and HPV. It reportedly “did not show promise” in a recent clinical trial in China, but was “underpowered,” possibly skewing results, and is still being studied by the WHO and perhaps others.
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