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2020-05-21 at 12:30 AM UTC in What happened to hydroxychloriquine?Home
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FEATURED NEWS TOPICSNovel CoronavirusEbolaMERS-CoVChronic Wasting Disease
Study calls into question use of malaria drug for COVID-19
Filed Under: COVID-19
Chris Dall | News Reporter | CIDRAP News | Apr 23, 2020
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hydroxychloroquine_tablets.jpg
Hydroxychloroquine tablets
Bartek Szewczyk / iStock
A retrospective study of patients with COVID-19 at Veterans Affairs (VA) hospitals found no evidence that the antimalaria drug hydroxychloroquine, either with or without the antibiotic azithromycin, reduced mortality or the need for mechanical ventilation.
Researchers also found that hydroxychloroquine alone was associated with increased mortality.
The findings, published this week on the preprint server medRxiv, suggest hydroxychloroquine may not have as much promise for treating COVID-19 patients as initially hoped. The study was not a randomized controlled trial, so the implications of the findings are limited, and the results have not been peer-reviewed. Still, the authors say the results suggest clinicians need to be careful about using the drug in COVID-19 patients.
"Data from ongoing, randomized controlled studies will prove informative when they emerge," they wrote. "Until then, the findings from this retrospective study suggest caution in using hydroxychloroquine in hospitalized COVID-19 patients, particularly when not combined with azithromycin."
No benefit found
For the study, researchers with Columbia VA Health Care System, the University of South Carolina, and the University of Virginia School of Medicine looked at data from 368 VA patients with confirmed COVID-19 treated from Mar 9 until Apr 11.
The patients were assigned to one of three cohorts based on medication exposure: patients treated with hydroxychloroquine alone (97), patients treated with hydroxychloroquine and azithromycin (113), and patients who did not receive hydroxychloroquine (158). The two primary outcomes were death and the need for mechanical ventilation.
Overall, there were 27 deaths (27.8%) in the hydroxychloroquine group, 25 deaths (22.1%) in the hydroxychloroquine/azithromycin group, and 18 deaths (11.4%) in the group that did not receive hydroxychloroquine. Mechanical ventilation occurred in 13.3% of the hydroxychloroquine patients, 6.9% of the hydroxychloroquine/azithromycin patients, and 14.1% of the no-hydroxychloroquine group.
Multilevel statistical analysis of the outcomes showed that, compared with the group that did not receive hydroxychloroquine, the risk of death from any cause was more than two-and-a-half times higher in the hydroxychloroquine patients (adjusted hazard ratio
, 2.61; 95% confidence interval [CI], 1.10 to 6.17; P = 0.03), but was not significantly higher in the hydroxychloroquine/azithromycin patients (adjusted HR, 1.14; 95% CI, 0.56 to 2.32; P = 0.72).
The researchers observed no difference in the risk of ventilation in either the hydroxychloroquine group (adjusted HR, 1.43; 95% CI, 0.53 to 3.79; P = 0.48) or the hydroxychloroquine/ azithromycin patients (adjusted HR, 0.43; 95% CI, 0.16 to 1.12; P = 0.09) compared with the no-hydroxychloroquine group.
"Specifically, hydroxychloroquine use with or without co-administration of azithromycin did not improve mortality or reduce the need for mechanical ventilation in hospitalized patients," the authors wrote. "On the contrary, hydroxychloroquine use alone was associated with an increased risk of mortality compared to standard care alone."
The authors note that hydroxychloroquine, both with and without azithromycin, was more likely to be prescribed to sicker patients, which could play a role in the increased mortality findings. But the increase still persisted in the hydroxychloroquine-only patients when they adjusted the analysis for the propensity of being treated with the drug.
"We are likely seeing that the clinicians treating these patients were choosing hydroxychloroquine-based regimens for patients who were more ill," said Jason Gallagher, PharmD, a clinical professor and infectious diseases specialist at Temple University School of Pharmacy who was not involved in the study. But even with a propensity score adjustment, which attempts to account for differences between groups, "the hydroxychloroquine group had higher odds of death than patients who received standard of care.
"The hydroxychloroquine-azithromycin combination group did not do worse in this analysis, but they didn't do better, either," he added.
Current data don't support early hype
The findings from the study, which is the largest to date to report on outcomes from treating COVID-19 patients with the anti-malaria drug and uses a database that has been used for many different studies, suggest that the hydroxychloroquine/azithromycin combination may not be as promising for treating COVID-19 as some have hoped.
Early excitement about the combination was based on a French study that found hydroxychloroquine was significantly associated with the reduction and disappearance of the COVID-19 viral load in a handful of patients, and that the effect was enhanced by azithromycin. The authors of the study recommended that the repurposed drug, in combination with azithromycin, be used for treating COVID-19 patients, and President Donald Trump soon began touting the combination as a potential "game changer."
The Food and Drug Administration (FDA) issued an Emergency Use Authorization for hydroxychloroquine and chloroquine in late March, allowing for the drugs to be donated to the National Strategic Stockpile for use in COVID-19 patients. The drug is now being used widely to treat COVID-19, both alone and with azithromycin, despite concerns that have been raised about the methodology of the French study, which was not randomized, and results from subsequent studies that have shown little benefit in COVID-19 patients.
There are also concerns about the potential for the hydroxychloroquine/azithromycin combination to prolong the QT interval, which can cause an irregular heartbeat and increase the risk of sudden cardiac arrest. A recent study by researchers with New York University Langone Health found that 11% of COVID-19 patients treated with the hydroxychloroquine/azithromycin combination experienced severely prolonged QT intervals.
Gallagher said the potential for hydroxychloroquine/azithromycin to increase the risk for a potentially fatal heart arrythmia concerns him.
"In the studies of hospitalized patients who receive them, patients receive monitoring," he said. "That is unlikely to occur with outpatient use."
In addition, the interest in hydroxychloroquine, which is also used to treat lupus and rheumatoid arthritis, has led to shortages of the drug, affecting patients who need it for those conditions.
Gallagher said that while he understands people's desperation for a potential treatment for COVID-19, the data right now don't support the use of hydroxychloroquine.
"We need to remember that this is not the first virus that hydroxychloroquine has been tried against. It has in vitro activity against many viruses—Zika, chikungunya, even HIV," he said, referring to lab studies. "But it has never translated into clinical success."
New NIH guidelines agree
New treatment guidelines for COVID-19 released this week by the National Institutes of Health (NIH) have come to the same conclusion.
The guidelines, developed by a panel of experts from federal agencies and professional societies, concluded that the data are insufficient to recommend any antiviral or immunomodulatory therapy for COVID-19 patients who have mild, moderate, or severe illness. The panel recommended that any promising, unapproved, or unlicensed treatment for COVID-19, including drugs like hydroxychloroquine that have been approved for other indications, be studied in well-designed controlled clinical trials.
"Although reports have appeared in the medical literature and the lay press claiming successful treatment of patients with COVID-19 with a variety of agents, definitive clinical trial data are needed to identify optimal treatments for this disease," the panel wrote.
Outside of clinical trials, several of which are now being conducted, the panel recommended against the use of hydroxychloroquine/azithromycin for COVID-19 because of the potential for toxicities.
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2020-05-21 at 12:30 AM UTC in What happened to hydroxychloriquine?Home
News & Perspective
Infectious Disease Topics
Antimicrobial Stewardship
Ongoing Programs
About Us
DONATE NOW
FEATURED NEWS TOPICSNovel CoronavirusEbolaMERS-CoVChronic Wasting Disease
Study calls into question use of malaria drug for COVID-19
Filed Under: COVID-19
Chris Dall | News Reporter | CIDRAP News | Apr 23, 2020
Share Tweet LinkedIn Email Print & PDF
hydroxychloroquine_tablets.jpg
Hydroxychloroquine tablets
Bartek Szewczyk / iStock
A retrospective study of patients with COVID-19 at Veterans Affairs (VA) hospitals found no evidence that the antimalaria drug hydroxychloroquine, either with or without the antibiotic azithromycin, reduced mortality or the need for mechanical ventilation.
Researchers also found that hydroxychloroquine alone was associated with increased mortality.
The findings, published this week on the preprint server medRxiv, suggest hydroxychloroquine may not have as much promise for treating COVID-19 patients as initially hoped. The study was not a randomized controlled trial, so the implications of the findings are limited, and the results have not been peer-reviewed. Still, the authors say the results suggest clinicians need to be careful about using the drug in COVID-19 patients.
"Data from ongoing, randomized controlled studies will prove informative when they emerge," they wrote. "Until then, the findings from this retrospective study suggest caution in using hydroxychloroquine in hospitalized COVID-19 patients, particularly when not combined with azithromycin."
No benefit found
For the study, researchers with Columbia VA Health Care System, the University of South Carolina, and the University of Virginia School of Medicine looked at data from 368 VA patients with confirmed COVID-19 treated from Mar 9 until Apr 11.
The patients were assigned to one of three cohorts based on medication exposure: patients treated with hydroxychloroquine alone (97), patients treated with hydroxychloroquine and azithromycin (113), and patients who did not receive hydroxychloroquine (158). The two primary outcomes were death and the need for mechanical ventilation.
Overall, there were 27 deaths (27.8%) in the hydroxychloroquine group, 25 deaths (22.1%) in the hydroxychloroquine/azithromycin group, and 18 deaths (11.4%) in the group that did not receive hydroxychloroquine. Mechanical ventilation occurred in 13.3% of the hydroxychloroquine patients, 6.9% of the hydroxychloroquine/azithromycin patients, and 14.1% of the no-hydroxychloroquine group.
Multilevel statistical analysis of the outcomes showed that, compared with the group that did not receive hydroxychloroquine, the risk of death from any cause was more than two-and-a-half times higher in the hydroxychloroquine patients (adjusted hazard ratio
, 2.61; 95% confidence interval [CI], 1.10 to 6.17; P = 0.03), but was not significantly higher in the hydroxychloroquine/azithromycin patients (adjusted HR, 1.14; 95% CI, 0.56 to 2.32; P = 0.72).
The researchers observed no difference in the risk of ventilation in either the hydroxychloroquine group (adjusted HR, 1.43; 95% CI, 0.53 to 3.79; P = 0.48) or the hydroxychloroquine/ azithromycin patients (adjusted HR, 0.43; 95% CI, 0.16 to 1.12; P = 0.09) compared with the no-hydroxychloroquine group.
"Specifically, hydroxychloroquine use with or without co-administration of azithromycin did not improve mortality or reduce the need for mechanical ventilation in hospitalized patients," the authors wrote. "On the contrary, hydroxychloroquine use alone was associated with an increased risk of mortality compared to standard care alone."
The authors note that hydroxychloroquine, both with and without azithromycin, was more likely to be prescribed to sicker patients, which could play a role in the increased mortality findings. But the increase still persisted in the hydroxychloroquine-only patients when they adjusted the analysis for the propensity of being treated with the drug.
"We are likely seeing that the clinicians treating these patients were choosing hydroxychloroquine-based regimens for patients who were more ill," said Jason Gallagher, PharmD, a clinical professor and infectious diseases specialist at Temple University School of Pharmacy who was not involved in the study. But even with a propensity score adjustment, which attempts to account for differences between groups, "the hydroxychloroquine group had higher odds of death than patients who received standard of care.
"The hydroxychloroquine-azithromycin combination group did not do worse in this analysis, but they didn't do better, either," he added.
Current data don't support early hype
The findings from the study, which is the largest to date to report on outcomes from treating COVID-19 patients with the anti-malaria drug and uses a database that has been used for many different studies, suggest that the hydroxychloroquine/azithromycin combination may not be as promising for treating COVID-19 as some have hoped.
Early excitement about the combination was based on a French study that found hydroxychloroquine was significantly associated with the reduction and disappearance of the COVID-19 viral load in a handful of patients, and that the effect was enhanced by azithromycin. The authors of the study recommended that the repurposed drug, in combination with azithromycin, be used for treating COVID-19 patients, and President Donald Trump soon began touting the combination as a potential "game changer."
The Food and Drug Administration (FDA) issued an Emergency Use Authorization for hydroxychloroquine and chloroquine in late March, allowing for the drugs to be donated to the National Strategic Stockpile for use in COVID-19 patients. The drug is now being used widely to treat COVID-19, both alone and with azithromycin, despite concerns that have been raised about the methodology of the French study, which was not randomized, and results from subsequent studies that have shown little benefit in COVID-19 patients.
There are also concerns about the potential for the hydroxychloroquine/azithromycin combination to prolong the QT interval, which can cause an irregular heartbeat and increase the risk of sudden cardiac arrest. A recent study by researchers with New York University Langone Health found that 11% of COVID-19 patients treated with the hydroxychloroquine/azithromycin combination experienced severely prolonged QT intervals.
Gallagher said the potential for hydroxychloroquine/azithromycin to increase the risk for a potentially fatal heart arrythmia concerns him.
"In the studies of hospitalized patients who receive them, patients receive monitoring," he said. "That is unlikely to occur with outpatient use."
In addition, the interest in hydroxychloroquine, which is also used to treat lupus and rheumatoid arthritis, has led to shortages of the drug, affecting patients who need it for those conditions.
Gallagher said that while he understands people's desperation for a potential treatment for COVID-19, the data right now don't support the use of hydroxychloroquine.
"We need to remember that this is not the first virus that hydroxychloroquine has been tried against. It has in vitro activity against many viruses—Zika, chikungunya, even HIV," he said, referring to lab studies. "But it has never translated into clinical success."
New NIH guidelines agree
New treatment guidelines for COVID-19 released this week by the National Institutes of Health (NIH) have come to the same conclusion.
The guidelines, developed by a panel of experts from federal agencies and professional societies, concluded that the data are insufficient to recommend any antiviral or immunomodulatory therapy for COVID-19 patients who have mild, moderate, or severe illness. The panel recommended that any promising, unapproved, or unlicensed treatment for COVID-19, including drugs like hydroxychloroquine that have been approved for other indications, be studied in well-designed controlled clinical trials.
"Although reports have appeared in the medical literature and the lay press claiming successful treatment of patients with COVID-19 with a variety of agents, definitive clinical trial data are needed to identify optimal treatments for this disease," the panel wrote.
Outside of clinical trials, several of which are now being conducted, the panel recommended against the use of hydroxychloroquine/azithromycin for COVID-19 because of the potential for toxicities.
Share this page: Share Tweet LinkedIn Email Print & PDF
NEWSLETTER SIGN-UP
Get CIDRAP news and other free newsletters.
Sign up now»
OUR UNDERWRITERS
Unrestricted financial support provided by
Bentson Foundation Gilead
Grant support for ASP provided by
bioMérieux
Become an underwriter»
RELATED NEWS ALL NEWS
MAY
20
2020
CDC's COVID-19 reopening guidelines released
MAY
20
2020
As COVID-19 cases near 5 million, WHO sees long road ahead
MAY
20
2020
Critical illness common in New York COVID-19 inpatients: study
MAY
19
2020
Scientists isolate live COVID-19 virus from feces, detect RNA on surfaces
MAIN MENU
HomeNews & PerspectiveInfectious Disease TopicsAntimicrobial StewardshipOngoing Programs
Antimicrobial Stewardship
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CONNECT WITH US
Newsletter Signup
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CIDRAP - Center for Infectious Disease Research and Policy
Office of the Vice President for Research, University of Minnesota, Minneapolis, MN
© 2020 Regents of the University of Minnesota. All rights reserved.
The University of Minnesota is an equal opportunity educator and employer.
CIDRAP | Office of the Vice President for Research | Contact U of M | Privacy Policy -
2020-05-21 at 12:26 AM UTC in So this chick is telling me to call her... like not asking nicely but straight up demanding that shit... how do I respond?
Originally posted by Cathay Coof Insightful post there §m£ÂgØL.
The other day I was pulling my Pomeranian off the toddler she was mauling, and I had similar thoughts.
Why are people so breedist?
Pure ignorance and hate I concluded.
It's a cute equation you're trying to make, but not a very good troll. Keep trying kiddo -
2020-05-21 at 12:14 AM UTC in So this chick is telling me to call her... like not asking nicely but straight up demanding that shit... how do I respond?
Originally posted by Cathay Coof I googled, but couldn't find anything. Turns out that all the rumors about pitbulls were labrador-supremacist propaganda.
Told you. Pits are one of the most friendly and loving breeds imo.
German Shepards are another 'aggressive' breed but they're really high strung and anxious and you have to know what you're doing to own one.
Small dogs I think are the most bitey. Dachshunds and Chihuahuas in particular can have horrible attitudes.
Golden Retrievers are best. I have never met one which was 'bad'. Crazy, yes. But not a bad dog.
Also hounds are annoying and stupid as fuck. I hate hounds. -
2020-05-20 at 9:48 PM UTC in So this chick is telling me to call her... like not asking nicely but straight up demanding that shit... how do I respond?
Originally posted by Cathay Coof Oh.
And do they only attack other dogs and animals that deserve it too?
I have a whole bunch of liveleak videos of pitbulls attacking children ready to post, but I want to see your answer first.
Yep. They always deserve it, like I said. Post your videos. I'll point out where you're wrong -
2020-05-20 at 9:35 PM UTC in Maciej Wieslaw Lata appears in court on molestation chargesOur form of system, yes Wariat
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2020-05-20 at 8:42 PM UTC in So this chick is telling me to call her... like not asking nicely but straight up demanding that shit... how do I respond?I guess we tell him what to do?
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2020-05-20 at 8:04 PM UTC in Maciej Wieslaw Lata appears in court on molestation charges
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2020-05-20 at 8:03 PM UTC in Maciej Wieslaw Lata appears in court on molestation chargesCalifornia courts are working with Raphael Luciano
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2020-05-20 at 8:02 PM UTC in I have decided to become fluent in Mandarin
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2020-05-20 at 8:02 PM UTC in Maciej Wieslaw Lata appears in court on molestation charges10 pages of everybody ripping the fuck out of wariat lol
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2020-05-20 at 8:01 PM UTC in Maciej Wieslaw Lata appears in court on molestation charges
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2020-05-20 at 7:56 PM UTC in If Jesus was alive today he would be a socialist
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2020-05-20 at 7:56 PM UTC in Maciej Wieslaw Lata appears in court on molestation charges
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2020-05-20 at 7:51 PM UTC in Maciej Wieslaw Lata appears in court on molestation chargesLol no not everybody can get a restraining order. There typically has to be evidence that the person in question poses a threat to you. I tried to get one before and couldn't for that very reason.
In California where this happened, the law says:To ask for a civil harassment restraining order there are several steps you have to take. But first make sure that:
1. A restraining order is right for you. Read Can a Civil Harassment Restraining Order Help Me? (Form CH-100-INFOPDF file type icon).
2. You qualify for a civil harassment restraining order. You qualify if:
The person you want to restrain has stalked, harassed, sexually assaulted, or threatened you with violence;
and
The person you want to restrain is your:
neighbor,
roommate,
friend,
family member more than 2 degrees removed, like an aunt or uncle, a niece or nephew, cousins, and more distant relatives, or
another person you are not closely related to.
https://www.courts.ca.gov/1278.htm?rdeLocaleAttr=en -
2020-05-20 at 7:46 PM UTC in So this chick is telling me to call her... like not asking nicely but straight up demanding that shit... how do I respond?That dog is adorable. I told you they were sweeties.
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2020-05-20 at 7:45 PM UTC in If Jesus was alive today he would be a socialist
Originally posted by the man who put it in my hood No, he would be a christian. The leader of his political party is God.
Jesus refused to accept political office. (John 6:15) He taught his disciples to be “no part of the world” and made it clear that they should not take sides in political issues. John 17:14, 16; 18:36 Mark 12:13-17.
so republicans are all hypocrites -
2020-05-20 at 7:38 PM UTC in If Jesus was alive today he would be a socialistWhoever gives to the poor will not want, but he who hides his eyes will get many a curse. - Proverbs 28:27
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2020-05-20 at 7:37 PM UTC in If Jesus was alive today he would be a socialistBear one another's burdens, and so fulfill the law of Christ. - Galatians 6:2
For I do not mean that others should be eased and you burdened, but that as a matter of fairness your abundance at the present time should supply their need, so that their abundance may supply your need, that there may be fairness. As it is written, “Whoever gathered much had nothing left over, and whoever gathered little had no lack.” - Corinthians 8:13-15
Jesus said to him, “If you would be perfect, go, sell what you possess and give to the poor, and you will have treasure in heaven; and come, follow me.” - Matthew 19:21
But if anyone has the world's goods and sees his brother in need, yet closes his heart against him, how does God's love abide in him? - John 3:17
Come now, you rich, weep and howl for the miseries that are coming upon you. Your riches have rotted and your garments are moth-eaten. Your gold and silver have corroded, and their corrosion will be evidence against you and will eat your flesh like fire. You have laid up treasure in the last days. Behold, the wages of the laborers who mowed your fields, which you kept back by fraud, are crying out against you, and the cries of the harvesters have reached the ears of the Lord of hosts. You have lived on the earth in luxury and in self-indulgence. You have fattened your hearts in a day of slaughter.- James 5:1-6
“If your brother becomes poor and cannot maintain himself with you, you shall support him as though he were a stranger and a sojourner, and he shall live with you. Take no interest from him or profit, but fear your God, that your brother may live beside you. You shall not lend him your money at interest, nor give him your food for profit. I am the Lord your God, who brought you out of the land of Egypt to give you the land of Canaan, and to be your God - Leviticus 25:35-38
This is what the Lord has commanded: ‘Gather of it, each one of you, as much as he can eat. You shall each take an omer, according to the number of the persons that each of you has in his tent.’” And the people of Israel did so. They gathered, some more, some less. But when they measured it with an omer, whoever gathered much had nothing left over, and whoever gathered little had no lack. Each of them gathered as much as he could eat. - Exodus 16:16-18
