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The official student newspaper of Vanderbilt University

The Vanderbilt Hustler

The official student newspaper of Vanderbilt University.
The official student newspaper of Vanderbilt University

The Vanderbilt Hustler

The official student newspaper of Vanderbilt University.

Official ORCHID trial results to be released shortly, will tell us effectivity of hydroxychloroquine in acute COVID-19 cases

Hydroxychloroquine is an effective therapy for a number of illnesses, and ORCHID looks to determine its safety and efficacy in hospitalized COVID-19 patients.
Mattigan Kelly
According to its website, Vanderbilt University Medical Center “cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.” (Hustler Multimedia/Mattigan Kelly).

Editor’s Note: The quote from Lindsell speaking about the results of the study has since been removed as requested by Lindsell.

Vanderbilt University Medical Center (VUMC)’s ORCHID trial results to determine the safety and effectiveness of hydroxychloroquine (HCQ) in hospitalized COVID-19 patients are forthcoming. 

Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID)’s trial finished on June 19 after sufficient data had been collected. The data suggested that hydroxychloroquine had no benefit or harm to the patients in the trial. The official results of the trial were submitted last week to the National Institute of Health (NIH) and are currently undergoing peer-review, according to Dr. Christopher Lindsell.

Per Lindsell, the official date for the publication is yet to be determined. 

“It will all depend on when the journal accepts the manuscript,” Lindsell said.

Dr. Christopher Lindsell, a member of the ORCHID trial team, is also a biostatistician, co-director of the HEAlth Data Science (HEADS) Center and a professor of biostatistics at Vanderbilt. 

At the beginning of the trial, Lindsell created the database system, so that the data could be collected appropriately. He also worked with statisticians to create a system to analyze the data. During the trial, Lindsell said he looked at the results as they came in to determine whether or not more data was needed by incorporating a bayesian framework. 

About Hydroxychloroquine & the Trial at VUMC

Although laboratory studies had shown the promise of hydroxychloroquine (HCQ) as a therapy for COVID-19, no clinical trials had been conducted in patients according to the VUMC report prior to ORCHID.

On March 28, the Food and Drug Administration (FDA) issued an emergency use authorization to treat patients hospitalized with COVID-19 with HCQ. This order was declared prior to clinical trials to evaluate its safety and effectiveness in COVID-19 patients. The order was later revoked on June 15.

In order to determine if HCQ would speed recovery or prevent complications in severe cases of the virus, the VUMC led the ORCHID trial to attain clinical data. The trial began on April 2 according to the VUMC report.

The trial was conducted at medical centers across the country. It was also blinded, placebo-controlled and randomized with a total of 479 patients enrolled. The fact that the trial was blinded meant that neither patients nor clinicians knew who was receiving the placebo versus the HCQ and the treatment groups were randomly assigned. 

Conducting a Clinical Trial during a Pandemic

ORCHID was conducted during an international pandemic, and this came with its own set of obstacles for the team. 

“COVID, time, money—it’s huge,” Lindsell said.“How do you consent a patient when you aren’t allowed to go near that patient, or touch them or remove a piece of paper from their hospital room?” 

Informed consent is when clinicians provide information regarding the potential risks, protocol and uncertainty of the trial to the patient. According to Lindsell, the social distancing requirements surrounding the pandemic made it difficult to have a meaningful conversation with patients. 

Time was another obstacle the team faced. They had to create a protocol for the trial that could be scaled to medical centers around the country in a short period of time per Lindsell. This protocol was implemented at over 30 medical centers, Lindsell said.

“We were dealing with the adrenaline rush in academic timescale, of trying to solve massive problems quickly,” Lindsell said, “There is always, when working at that pace, a fear that by going too fast that attention to detail, rigor and reproducibility is insufficient, and that mistakes can creep in, which actually had a beneficial purpose of ensuring we took the right steps to do it properly. 

Per Lindsell, politics have also played a large role in HCQ and had an impact on recruiting patients for the trial.

“I think it is fair to say that the politicization of COVID, covid treatments, and public health response resulted in some patients making decisions based not on fact but on belief,” Lindsell said.

Despite such challenges, Lindsell said that the trial was conducted successfully and fairly quickly.

“This particular trial occurred at a time when every single skid was greased, everyone was working together to solve a common problem, so all of the typical slowdowns in clinical trials were avoided,” Lindsell said. “The sense of teamwork was really strong, and it is extraordinary what can be accomplished in a very short period of time when people do that. Typically what would have taken a year or more in start-up time took 14 days.”

A Successful Trial

Lindsell said that the success of the ORCHID trial demonstrates Vanderbilt’s leadership in clinical trials, acute care and critical care as well as in many other places. 

“It is why we got PassItOn and the funding for that is because ORCHID worked so well led by Vanderbilt. So, it has further cemented our leadership role in this kind of research, nationally and internationally,” Lindsell said. 

The publication time is dependent on the length of time for academic peer review. Although it is unknown where and when the official results of the trial will be published, it will be in the next few weeks per Lindsell.

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About the Contributors
Jazlyn Selvasingh
Jazlyn Selvasingh, Former Staff Writer
Jazlyn Selvasingh ('23) is from Seattle, WA and is majoring in biochemistry in the College of Arts and Sciences. When not writing for The Hustler, Jazlyn loves working on her research projects, going for runs, chilling with her pet turtle and reading/hearing stories.
Mattigan Kelly
Mattigan Kelly, Former Deputy Multimedia Director
Mattigan Kelly ('22) was Deputy Multimedia Director for The Vanderbilt Hustler. She has been on the staff since her freshman year. Mattigan majored in chemical engineering in the School for Engineering. In addition to shooting for The Hustler, she was the Development Coordinator for Camp Kesem at Vanderbilt, works in a research lab on campus and plays Club Tennis.
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John D. Horton
3 years ago

Belgium peer reviewed observational study 8000 patients 30% reduction in death for those on hydroxy, Italian peer reviewed study 3000 patients 30% reduction in death, Henry Ford 2000+peer reviewed study 50% reduction in death. Veterans hospital study shows, well a higher rate of death among those given hydroxy. Oh maybe you didnt see later data showing a pre existing 50% lower white blood cell count in those given hydroxy than those in the control group) Thats ok, it did its work-discrediting hydroxy use. That isnt quite true, the Lancet study results impelled the WHO to stop studying hydroxy…later the study was discredited and withdrawn in disgrace. Thats ok, the DISCOVERY study in Oxford stepped up to the plate and showed a higher level of deaths in the hydroxy group..and that killed off for good the WHO trials as far as I know.Wait, did I mention that the DISCOVERY trial used initially about 6x (2.4 grams/day) the maximum recommended dose? From what I have gathered-thats pushing toward the lethal range.. I am not a doctor but articles were published showing deep alarm about the dosage.What about the Brazilian study that showed no effect..ok. Oh wait did a mention a later statistical significant analysis showed that if you took those in the study treated very early(per recommended protocol-what a radical idea!) you actually had, I think it was 70%, reduction in death. One more thing – Dr. Fauci called the Henry Ford study “flawed”. Why? because, he said, “steroids were given to some who were also given hydroxy”(I never read anywhere he was simply glad that lives seem to be saved-maybe he did). Oh, did I mention that Henry Ford came out later and separated out the variables and still found that hydroxy lowered the death rate. Well, for all those “oh did I mentions”, neither the media,the FDA, and seemingly the overwhelming majority of the medical establishment, (and Dr Fauci) didnt mention it either. Now the 30 and 50% reduction in death was only for hospitalized patients-generally after autoimmune storm-not the most effective use. What about the case of Dr Steve Crawford who early before the drug became one that would kill the **** out of you(you saw all those scary newscasts didnt you? ) treated 52 of the 64 high risk patients in his nursing home(12 wouldnt let him) all 52 treated lived10 of 12 nontreated died) . I could go on for awhile more, honestly. All the things I mentioned are easily accessible with a Google search. there is much more evidence for its efficacy in early treatment.
I am truly grateful for science(I was a scientist for 20 years), doctors and medicine. I am asking for some brave people to honestly look into this and start saving lives. When an honest doctor made a mistake that almost killed my wife and he admitted it later I forgave him. I felt he was a competent, good willed man ,with feet of clay like me,doing the best he knew how….but he did admit it-that was very important to me. Please, anybody reading this, look into what tens of thousands are crying out to be looked into. If we are in the main wrong, show us where! I have been begging media outlets and hospital administrators for months to give this an honest hearing. I am crying out for those who have no voice. If you think we who have researched this are seeing something real, please spread the word. Pleases act.

Bryn Duffy
3 years ago

No ZInc? No early intervention.
This is all so very shameful.
Look in the mirror, guys, and tell yourselves that you are legitimately pursuing the truth.
Do you blink a lot, avoid eye contact? Yah, that is understandable. Hey, when you decide to put your patients and humanity first, you might start feeling that self-respect you crave.
The good news, if you can call it “good”, is that the continuous series of lies and misleading advice from once trusted medical professional has made the public rightly skeptical. So there is that.

John D. Horton
3 years ago

For about 6 months now we have in vain been looking for our hospitals to explore early use of hydroxy…or hydroxy/azith/zinc. The medical community in general seems to be willing to explore many aspects of hydroxy use. The only protocol they seem to strenuously resist is, well, the one where it is mainly claimed to work well-that is early treatment per Dr Vladimir Zelenko and/or Dr.Didier Raoult. Essentially no media outlet will intelligently address this. Pharmacists are refusing to give prescriptions out even if given under legal off label usage(at least about a month ago when a local doctor told a TV interviewer he couldnt find any pharmacy to fill his prescriptions). There are a few brave doctors like Yales brilliant epidimiologist Harvey Risch who have tried to remedy the lockdown on this drug. To all medical professionals, I ask you this question. “Wonder if Dr Risch is right, that we could save 10’s of thousands of people from choking to death on their own blood by an early use protocol?” I challenge you to make a “hard nosed” investigation of all sources concerning this. I only ask that you include Dr Rischs paper, and Didier Raoult + Vladimir Zelenko in their Twitter accounts. I honestly believe that the overwhelming evidence suggests you could save many,many lives. All I ask is an open mind that intelligently and honestly considers all sides. ..and a willingness to act on what you learn. I appeal to the thing that drove many of you to pursue medicine: The love of seeing a fellow human being be healed.

Boyd Zander
3 years ago

Ms Selvasingh, thank you for the report. Appreciate it. It has been well established that the primary efficacy of HCQ (low dose!) is arrived at when applied early and used in conjunction with Zinc and Azithromycin. Work by Dr. Zelenko, Dr. Raoult, and etc. have established this. Actual studies have established this.
Performing a study for potential efficacy using with HCQ alone when the cases have progressed to hospitalization does not make sense. In my opinion, studies should be trying to prove what is expected to succeed, not what is expected to fail. Even lay persons know that HCQ used alone after hospitalization is likely to show significantly decreased efficacy when compare to that arrived at when treatment is early using HCQ/Zinc.
If the study used HCQ alone, and ignored the well known and established treatment protocols, I would suggest that the trial could not be called a success. Treatment with HCQ alone after hospitalization shameful in my opinion.
A good addendum to your reporting would be provision of what the actual protocol was, i.e HCQ alone or in combination. What dose HCQ was used, was it a low dose as is required or a toxic dose? If the study did not use primarily Zinc or Azithromycin with the HCQ, a good follow on question would be why.

Frank Kushner
3 years ago

No mention of zinc which has been shown to be needed for early intervention. If there is no data on zinc given or how much was in patients’ blood throw the study where the lancet study and the US VA studies are: in the sewer. Also hope not a deadly dose of HCQ was used in any of hospitals as in recent study in Europe.
For the truth see
Also a small spanish tclinical trial showed great results for HCQ and high dose Vitamin D. P<0.001 for not going to ICU. No deaths for 50 compared to 2 out of 26 with pneumonia.

David H.
3 years ago

Exactly what is to be gained by treating patients with an antiviral drug in the hospital when it is obviously too late to be effective? Hydroxychloroquine sulfate has a 5-day temporal limitation, so one would either have to be an idiot or scamming the public to wait until one has become a hospitalized patient before treating. This lengthy delay is never part of any other antiviral therapy, so why COVID-19?