New Hydroxychloroquine Trial Could Be Destined to Fail

AP Photo/John Locher

The politicization of hydroxychloroquine has been one of the most frustrating aspects of Trump Derangement Syndrome during this pandemic. Early studies in France and clinical outcomes from multiple treating physicians using a combination therapy that included the drug provided hope to combat the virus. However, it made President Trump hopeful, so it had to be obliterated.


Crappy studies of the drug given to the most severe patients were touted as proof the president was wrong. Then there was Fish Tank Cleaner Gate. This is the problem with political reporters covering press briefings about a pandemic. They either aren’t provided an internet connection by their employers or are too lazy to do 15 minutes of research.

Now, the NIH has finally announced it will begin a clinical trial using hydroxychloroquine and azithromycin in COVID-19 patients with mild to moderate symptoms. Every clinician who has advocated hydroxychloroquine-azithromycin has said this is the appropriate stage of the disease to use the drug combination. Dr. Vladimir Zelenko began giving it to diagnosed and presumed COVID-19 patients during a severe outbreak in New Rochelle, New York. He started the drug when patients were suffering from mild shortness of breath.

Dr. Anthony Cardillo also explained how he effectively used the drug. His method was to give the medicine with azithromycin and zinc for a specific biological reason. This mineral needs to be added to the NIH trial based on volumes of scientific research on how it works in combination with hydroxychloroquine. Cardillo explained it succinctly:

“It was actually the hydroxychloroquine opening up a channel in the cellular membranes allowing zinc to come into the cells,” he said, “And we do know high levels of zinc inside of the cell that’s infected with the virus shuts down that viral replication machinery.”


The reaction to hydroxychloroquine was very perplexing. The NIH studied drug’s older cousin chloroquine following the SARS epidemic. In 2005 the NIH noted chloroquine had both prophylactic effects for prevention and anti-viral effects in cell cultures:


Chloroquine is effective in preventing the spread of SARS CoV in cell culture. Favorable inhibition of virus spread was observed when the cells were either treated with chloroquine prior to or after SARS CoV infection. In addition, the indirect immunofluorescence assay described herein represents a simple and rapid method for screening SARS-CoV antiviral compounds.

Because of how the drug works, especially in combination with zinc, Dr. Anthony Fauci’s inability to articulate the clinical case for exploring it was quite odd. His own agency had investigated chloroquine in a dozen ways following the SARS outbreak. It makes logical sense if chloroquine could inhibit viruses in vitro that its lower-risk cousin would have a similar effect. The science was always on the president’s side for use of the three-drug combination in the early course of illness. Fauci’s inability to articulate it was maddening and, in my own opinion, quite suspicious.

In the press release for the NIH’s new hydroxychloroquine study, Dr. Fauci offers a rationale for the new trial:


“We urgently need a safe and effective treatment for COVID-19. Repurposing existing drugs is an attractive option because these medications have undergone extensive testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment,” said NIAID Director Anthony S. Fauci, M.D. “Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes.”

I agree wholeheartedly. With a background and education in health care, I would be loath to take a drug that is not at least 10 years old and preferably a generic. By then all side effects are known, the class action suits have started, and you know it doesn’t have a black box warning. I’d prefer this cocktail to the new drug Remdesivir any day of the week based on age and previous usage.

However, every clinician who has shared his or her success in treating patients early emphasized the role of zinc. Hydroxychloroquine holds the door to the cell open so zinc can run inside and stop the virus from making photocopies of itself. They work together to stop the viral load from increasing so the patient’s own immune system has a better shot. The NIH trial does not include the mineral. This requires some explanation given what the NIH already knows.


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