Recent Forum Topics › Forums › The Public House › Chloroquine, other approaches
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April 4, 2020 at 6:22 pm #113336wvParticipant
Chloroquine inhibits the virus in test-tubes, is used with Lupus patients as an anti-inflamatory. Might prove effective, might not.
This scientist has some thots on other approaches.
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April 4, 2020 at 8:36 pm #113338znModerator“Solidarity” clinical trial for COVID-19 treatments
“Solidarity” is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.
The Solidarity trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.
Until there is sufficient evidence, WHO cautions against physicians and medical associations recommending or administering these unproven treatments to patients with COVID-19 or people self-medicating with them. WHO is concerned by reports of individuals self-medicating with chloroquine and causing themselves serious harm. WHO guidance on compassionate use can be found here.
Key Links
Landscape analysis of therapeutics21 March 2020
18 March 2020
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 18 March 2020
Rationale
The pressure COVID-19 puts on health systems means that WHO considered the need for speed and scale in the trial. While randomized clinical trials normally take years to design and conduct, the Solidarity trial will reduce the time taken by 80%.Enrolling patients in one single randomized trial will help facilitate the rapid worldwide comparison of unproven treatments. This will overcome the risk of multiple small trials not generating the strong evidence needed to determine the relative effectiveness of potential treatments.
Participation in Solidarity
The Solidarity trial provides simplified procedures to enable even overloaded hospitals to participate, with no paperwork required. As of March 27 2020, over 70 countries have already confirmed they will contribute to the trial, with many others in the process of joining.The greater the number of participating countries, the faster results will be generated. WHO is facilitating access to thousands of treatment courses for the trial through donations from a number of manufacturers. WHO is also inviting developers and companies to collaborate on ensuring affordability and availability of the treatment options if they prove effective.
Treatment options under study
Based on evidence from laboratory, animal and clinical studies, the following treatment options were selected: Remdesivir; Lopinavir/Ritonavir; Lopinavir/Ritonavir with Interferon beta-1a; and Chloroquine or Hydroxychloroquine.Remdesivir was previously tested as an Ebola treatment. It has generated promising results in animal studies for Middle East Respiratory Syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS), which are also caused by coronaviruses, suggesting it may have some effect in patients with COVID-19.
Lopinavir/Ritonavir is a licensed treatment for HIV. Evidence for COVID-19, MERS and SARS is yet to show it can improve clinical outcomes or prevent infection. This trial aims to identify and confirm any benefit for COVID-19 patients. While there are indications from laboratory experiments that this combination may be effective against COVID-19, studies done so far in COVID-19 patients have been inconclusive.
Interferon beta-1a is used to treat multiple sclerosis.
Chloroquine and hydroxychloroquine are very closely related and used to treat malaria and rheumatology conditions respectively. In China and France, small studies provided some indications of possible benefit of chloroquine phosphate against pneumonia caused by COVID-19 but need confirmation through randomized trials.
Support for Solidarity
“The quest for knowledge about the coronavirus is a global effort. The Solidarity trial is an import part of the puzzle. I am proud that Norway will contribute both by having the first patient included in the study. I would like to commend the WHO for the global leadership and its initiative in setting up the Solidarity trial.”– Bent Høie, Minister of Health and Care Services, Norway
“There is only one way the world can exit this pandemic – and that is through science. We need diagnostics to detect and limit the spread of this virus, vaccines to provide long-term protection, treatments to save lives in the shorter-term and social science to understand the behavioural and societal implications. It’s critical that the global research effort is rapid, robust and is conducted at scale and co-ordinated across multiple countries. The World Health Organization’s Solidarity trial will provide this by testing existing and new drugs to treat COVID-19 and ensure equitable access to any drugs that prove effective. The start of these clinical trials is hugely important and an incredible achievement. Global powers must now step-up to ensure the WHO has all the support needed.”
– Dr Jeremy Farrar, Director of Wellcome and Chair of the WHO R&D Blueprint Scientific Advisory Group
How the Solidarity trial works
Adults with COVID-19 admitted to participant hospitals can join this study. Eligible patients will be asked to sign to show they understand the possible risks and benefits and consent to joining the study. The medical team responsible for each patient will check whether any of the study treatments would definitely be unsuitable.After those checks, brief identifying details and any other conditions are digitally recorded for the patient, who is then randomly allocated to one of the study options. This may or may not involve one of the study treatments. Neither the patient nor the medical staff choose which of the study options a patient will receive, as a computer makes this allocation at random.
Critical anonymized information for the trial will only be collected at the randomization stage and when the patient is discharged or dies: which study drugs were given (and for how many days); whether ventilation or intensive care was received (and, if so, when it began), date of discharge, or date and cause of death while still in hospital.
Interim trial analyses are monitored by a Global Data and Safety Monitoring Committee, which is an independent group of experts.
Countries, or particular groups of hospitals, may want to collaborate in making further serial measurements or observations, relating to areas such as virology, blood gases or chemistry and lung imaging. It also possible to incorporate documentation of other aspects of disease status, for example, through linking in electronic healthcare records and routine medical databases. While well-organised additional research studies of the natural history of the disease or of the effects of the trial treatments could well be valuable, they are not core requirements.
Adults (age ≥18 years) recently hospitalised, or already in hospital, with confirmed COVID-19 and, in the view of the responsible doctor, no contra-indication to any of the study treatments will be randomly allocated between
● Local standard of care,
OR local standard of care plus one of
● Remdesivir
● Chloroquine or Hydroxychloroquine
● Lopinavir with Ritonavir
● Lopinavir with Ritonavir plus Interferon beta-1a.
Underlying conditions recorded are: diabetes, heart disease, chronic lung disease, chronic liver disease and asthma, extending to HIV and tuberculosis in the African region.
Severity of illness at entry is determined by recording: shortness of breath, being given oxygen, already on a ventilator, and, if lungs imaged, major bilateral abnormality.
April 4, 2020 at 8:37 pm #113339znModeratorClinical Trials Set To Determine If Anti-Malaria Drug Effective Against COVID-19
A pack of Plaquenil, (Hydrochloroquine) is displayed in a Parisian pharmacy on Tuesday in Paris, France. Chloroquine or Hydroxychloroquine, is now one treatments being evaluated in clinical trials as a possible preventative or treatment for COVID-19.
Laurent Viteur/Getty Images
A nationwide trial is underway to see if the drug hydroxychloroquine can prevent disease in people exposed to the novel coronavirus. A second trial will test to see if the drug can prevent severe disease in people who are already showing COVID-19 symptoms.The trials are being run by David Boulware, an infectious disease scientist at the University of Minnesota.
“My normal research is doing clinical trials in Africa for fungal meningitis of the brain,” Boulware says.
But the COVID-19 demanded his attention. “Somebody needed to do something,” he says, “so I got my team together and we sort of jumped on this.”
That was on March 9. Eight days later, the trial was up and running. Hydroxychloroquine has been used for decades as a treatment for malaria. The rationale for trying it as a preventative for COVID-19 is based on laboratory studies that show the drug is capable of keeping the coronavirus from entering cells.
In the prevention part of the trial, Boulware and his colleagues are looking for people who recently had contact with someone who tested positive for the virus, for example healthcare workers or people living with someone who is infected. Recruiting is done online.
Once someone joins the study, they take either the drug or a placebo for five days. As of March 31, Boulware says he and his team had enrolled 558 volunteers. The aim is to recruit 1,500 people. With that number of volunteers, they should be able to determine if the drug is able to reduce the progression to disease by half or more.
The trial is double blind — neither the patients participating nor the doctors providing it know who is getting the active drug and who is getting the placebo.
Boulware says the trial has the approval of the Food and Drug Administration. Although the final results are several weeks off, a committee of independent experts known as the data safety and monitoring board will take an initial look at the results next week.
In the other part of the study, Bouware says his team is recruiting patients who are already showing signs of the disease. They are not giving the drug to people who are hospitalized.
Here again, patients will take hydroxychloroquine for five days to see if it slows the progression of the disease.
Many people, including President Trump, have been touting the promise of hydroxychloroquine without much data to back that up.
“Our goal is to find out, does this actually work,” Boulware says.
April 6, 2020 at 3:11 am #113376znModeratorHeated disagreement breaks out in Situation Room over hydroxychloroquine
CNN Digital Expansion 2017 Jim AcostaKaitlan Collins byline(CNN)There was a heated disagreement in the Situation Room this weekend over the efficacy of the anti-malaria drug hydroxychloroquine — but multiple sources say it was mostly one-sided, as President Donald Trump’s top trade adviser Peter Navarro feuded with other officials over the drug’s unproven effectiveness to treat coronavirus.
The debate is not a new one inside the coronavirus task force — and medical experts have repeatedly explained to the President that there is a risk in enthusiastically touting hydroxychloroquine in case the drug doesn’t ultimately work to combat the virus. But other aides and outside advisers have sided with Trump, including Navarro, who is still not a formal part of the task force but has wedged himself into the meetings.
Axios first reported on the disagreement inside the White House about the drug.
While discussing the latest on hydroxychloroquine this weekend, an exasperated Navarro lashed out at Dr. Anthony Fauci, one of the advisers who has urged caution about the drug, a person familiar with the meeting told CNN.
Navarro had brought a stack of paperwork with him into the Situation Room on the drug, arguing it was proof that it could work to treat coronavirus, which Fauci, the nation’s top infectious disease expert, disagreed with because it was not data.
“What are you talking about?” Fauci asked — a question that set Navarro off. He became indignant, and at one point, accused Fauci of opposing Trump’s travel restrictions on China, which confused many in the room, given Fauci was one of the initial few to agree with Trump on the move, the source said.A source close to the task force said Fauci is not backing off of his belief that hydroxychloroquine is not a proven treatment for coronavirus. When CNN’s Jeremy Diamond asked Fauci to comment on the matter Sunday night, Trump stepped in and didn’t allow Fauci to answer. But a source said the doctor has already offered his opinion on the drug in other venues and would continue to do so.
Several aides later said they were unfazed by Navarro’s outburst, given he has them regularly. But the argument highlights how deep the divide runs over the task force’s response to the coronavirus pandemic.
Another source told CNN that despite the disagreement in the Situation Room between Fauci and Navarro, Fauci continues to have a good relationship with Trump and Pence, though some staffers have shown irritation when his opinions differ.April 6, 2020 at 9:00 am #113377wvParticipant“we dont really understand seasonality”
April 7, 2020 at 12:12 am #113408znModeratorBTW there’s a lot of misleading info out there in the right-wing media about treatments and the data regarding them. The 2nd quotation here is from a great article.
1.
. https://www.statnews.com/2020/04/06/trump-hydroxychloroquine-fact-check/
In press releases, the FDA has stressed that “there are no currently approved treatments for COVID-19.” However, the agency says both hydroxychloroquine and chloroquine phosphate “have shown activity in laboratory studies against coronaviruses,” referring to a broad category of illnesses known as coronaviruses, not the 2019 strain that causes Covid-19. A number of federal agencies are currently working to facilitate clinical trials to determine whether or not the drug is effective.
2.
. https://rantt.com/right-wing-media-misrepresents-hydroxychloroquine-poll
The Post incorrectly reported: “Of the 6,227 physicians surveyed in 30 countries, 37 percent rated hydroxychloroquine the ‘most effective therapy’ for combating the potentially deadly illness, according to the results released Thursday.”
A press release from Sermo, the company that conducted the survey, said: “Hydroxychloroquine was overall chosen as the most effective therapy[b] amongst COVID-19 treaters.”[/b]
The Sermo survey shows that the subgroup of COVID-19 treaters is 2171 — not 6227, as multiple news outlets have since reported.
April 7, 2020 at 8:25 am #113411wvParticipantNYtimes:https://www.nytimes.com/2020/04/06/us/politics/coronavirus-trump-malaria-drug.html
Trump’s Aggressive Advocacy of Malaria Drug for Treating Coronavirus Divides Medical CommunityWhile Dr. Anthony Fauci has urged caution in using hydroxychloroquine, some doctors are prescribing it to patients who have the virus despite the fact it has never been tested for it.
WASHINGTON — President Trump made a rare appearance in the Situation Room on Sunday as his pandemic task force was meeting, determined to talk about the anti-malaria medicine that he has aggressively promoted lately as a treatment for the coronavirus.
Once again, according to a person briefed on the session, the experts warned against overselling a drug yet to be proved a safe remedy, particularly for heart patients. “Yes, the heart stuff,” Mr. Trump acknowledged. Then he headed out to the cameras to promote it anyway. “So what do I know?” he conceded to reporters at his daily briefing. “I’m not a doctor. But I have common sense.”
Day after day, the salesman turned president has encouraged coronavirus patients to try hydroxychloroquine with all of the enthusiasm of a real estate developer. The passing reference he makes to the possible dangers is usually overwhelmed by the full-throated endorsement. “What do you have to lose?” he asked five times on Sunday.
Bolstered by his trade adviser, a television doctor, Larry Ellison of Oracle and Rudolph W. Giuliani, a former New York mayor, Mr. Trump has seized on the drug as a miracle cure for the virus that has killed thousands and paralyzed American life. Along the way, he has prompted an international debate about a drug that many doctors in New York and elsewhere have been trying in desperation even without conclusive scientific studies.
Mr. Trump may ultimately be right, and physicians report anecdotal evidence that has provided hope. But it remains far from certain, and the president’s assertiveness in pressing the case over the advice of advisers like Dr. Anthony S. Fauci, the government’s top infectious disease specialist, has driven a wedge inside his coronavirus task force and has raised questions about his motives.
If hydroxychloroquine becomes an accepted treatment, several pharmaceutical companies stand to profit, including shareholders and senior executives with connections to the president. Mr. Trump himself has a small personal financial interest in Sanofi, the French drugmaker that makes Plaquenil, the brand-name version of hydroxychloroquine.
“I certainly understand why the president is pushing it,” said Dr. Joshua Rosenberg, a critical care at Brooklyn Hospital Center. “He’s the president of the United States. He has to project hope. And when you are in a situation without hope, things go very badly. So I’m not faulting him for pushing it even if there isn’t a lot of science behind it, because it is, at this point, the best, most available option for use.”
A senior physician at Wyckoff Heights Medical Center in Brooklyn, where doctors are not providing the drug, however, said the current demand was worrisome for patients on it chronically for rheumatic diseases. At St. Barnabas Hospital in the Bronx, another doctor said his staff was giving it to coronavirus patients but criticized the president and Gov. Andrew M. Cuomo for “cheerleading” the drug without proof. “False hope can be bad, too,” he said.
The professional organization that published a positive French study cited by Mr. Trump’s allies changed its mind in recent days. The International Society of Antimicrobial Chemotherapy said, “The article does not meet the society’s expected standard.” Some hospitals in Sweden stopped providing hydroxychloroquine to treat the coronavirus after reports of adverse side effects, according to Swedish news media.
But Mr. Cuomo told reporters on Monday that he would ask Mr. Trump to increase the federal supply of hydroxychloroquine to New York pharmacies, allowing the state to lift a limit on purchases. “There has been anecdotal evidence that it is promising,” Mr. Cuomo said, while noting the lack of a formal study….see link
April 11, 2020 at 10:38 am #113546nittany ramModeratorThis is a study from @waynestate, by the way, the university where I'm faculty. It's not truly randomized, but it is depressing. It suggests that, instead of benefiting #COVID19 patients, #Hydroxychloroquine might well cause harm. At the very least, this study shows zero benefit. https://t.co/DC6Shyhd7N
— David Gorski, MD, PhD (@gorskon) April 11, 2020
April 11, 2020 at 10:44 am #113548nittany ramModeratorHydroxychloroquine trial stopped due to major cardiac risk…
- This reply was modified 4 years, 8 months ago by nittany ram.
April 12, 2020 at 5:40 pm #113576wvParticipantIts being used in two London hospitals now, fwiw.
“..Hydroxychloroquine is being used at Barts in London and the Royal Devon and Exeter to keep critically ill coronavirus patients alive.
President Trump described the drug as a ‘game changer’ and it has been added to the Chinese guidance for tackling the disease, but up until now the NHS has strongly discouraged its use….”
April 13, 2020 at 9:54 pm #113612nittany ramModeratorA small (n = 440) Brazillian trial of chlorquine (not hydroxychloroquine) alongside azithromycin has been halted after 20 days because the drug had no benefit for #COVID19 patients and was killing people. https://t.co/omHLJCfQCR Do. Not. Recommend. Unproven. Therapies.
— Brian Dunning (@BrianDunning) April 13, 2020
April 18, 2020 at 5:31 pm #113785wvParticipantLAtimes:https://www.latimes.com/science/story/2020-04-17/malaria-drugs-fails-to-help-coronavirus-patients-in-controlled-studies
Malaria drugs fail to help coronavirus patients in controlled studiesBy Melissa HealyStaff Writer
April 17, 2020
3:08 PMThe malaria drugs touted by President Trump as potentially “the biggest game changers in the history of medicine” have received a decidedly more sober assessment of their coronavirus-fighting potential from researchers in China, France and Brazil.
Both chloroquine and its close relative hydroxychloroquine offered signs that they may ease some of the hallmark symptoms of coronavirus infection in patients who were hospitalized with COVID-19. But the drugs largely failed to deliver improvements on other key measures when evaluated in rigorous research studies.
In research done in France, hydroxychloroquine reduced neither deaths nor admissions to intensive care units among patients who received it. In a study conducted in China and another in Brazil, the two drugs failed to help patients clear the coronavirus faster.
And in Brazil, two deaths and a rash of heart troubles among patients who got a high dose of chloroquine prompted a hasty alteration of the trial there after just 13 days. Concluding that “enough red flags” had been raised, the researchers halted testing of the drug in its extra-strength form.
“My own impression so far is that these medications are a colossal ‘Maybe,’” said Dr. Michael H. Pillinger, a professor of medicine at New York University and chief of rheumatology at the Veterans Affairs’ New York Harbor Healthcare System.
“Is there enough possible benefit that we could use these on a wing and prayer until something better comes along? I’m underwhelmed” by the evidence for that, Pillinger said.
In the Brazil study, two of the 37 patients who were getting high doses of chloroquine developed ventricular tachycardia, a dangerous heart arrhythmia that led to their deaths. Five other patients in this arm of the trial developed QT interval prolongation, a condition that makes the heart’s electrical system slower to recharge between beats. It can cause the heart to beat erratically, also raising the risk of sudden death.
The death toll among patients who were randomly assigned to receive high-dose chloroquine did not rise above that in a comparison group of patients who did not get the drug. But researchers had set out to establish that high-dose chloroquine would save lives. When it failed to do so, they concluded the risks of cardiac side effects could not be justified.
“Preliminary findings suggest that the higher chloroquine dosage should not be recommended for COVID-19 treatment because of its potential safety hazards,” the study authors wrote in a report posted Thursday to MedRxiv, a clearinghouse for preliminary research results.
After the two deaths, the remaining 39 patients were switched to a lower dose of chloroquine, which was already being tested in 40 other patients. All would be tracked for an additional 13 days, with results still to come.
Brazilian President Jair Bolsonaro has allied himself closely with President Trump and has echoed his extravagant claims about chloroquine and hydroxychloroquine. He has ordered the Brazilian army to ramp up its orders of chloroquine and told the public that the malaria drugs “could go down in history as having saved thousands of lives in Brazil.”
The authors of the Brazil study, which was conducted in the Amazonian city of Manaus, suggested that Bolsonaro’s support complicated their efforts to test the drugs as rigorously as they would have liked.
Normally, they would have conducted a head-to-head comparison by randomly assigning some people to get the drugs while others received a dummy pill, or placebo. But since the drugs have been “recommended at the national level,” the researchers were unable to assign anyone to a group that would not get chloroquine. Instead, they used “historical data from the literature to infer comparisons.”
The French study of hydroxychloroquine, posted Tuesday to MedRxiv, followed a more conventional design. Researchers there enrolled 181 COVID-19 patients who were admitted to four French hospitals over the last two weeks of March, then compared the outcomes of 84 people who quickly received hydroxychloroquine to 91 patients who never received the drug. (Patients in both groups got a range of other treatments, including antiviral medications, corticosteroids and breathing support.)
The researchers found that treatment with hydroxychloroquine did not reduce the likelihood that a COVID-19 patient would die or be admitted to the intensive care unit within a week of hospital admission. Nor did it drive down a patient’s likelihood of developing serious breathing problems.
Hydroxychloroquine did, however, raise some risks. Eight of the 84 patients who got hydroxychloroquine experienced changes in heart rhythm that required discontinuation of the drug, and another patient developed a related heart-rhythm disorder.
“The negative clinical results of this study argue against the widespread use of hydroxychloroquine in patients with COVID-19 pneumonia,” the French researchers concluded.
Chinese researchers were just a bit more encouraging.
Their study, also posted to MedRxiv on Tuesday, found that COVID-19 patients who got hydroxychloroquine were no better at clearing the coronavirus from their systems than patients who didn’t get the drug. And at the 28-day mark, patients in both groups had the same number of symptoms.
But two weeks after admission to the hospital, patients who got hydroxychloroquine reported they felt better than their counterparts who did not. And they appeared to have lower levels of inflammation — a symptom of COVID-19 that can escalate and lead to death if unchecked. (In fact, in doses much lower than those tested in the COVID-19 trials, hydroxychloroquine is used to treat autoimmune diseases such as lupus and rheumatoid arthritis because of its anti-inflammatory effects.)
Also, while 30% of the patients who got hydroxychloroquine reported a side effect, just 9% of patients in the comparison group did so. None of these side effects appeared to be heart-related.
The Chinese researchers referred to “shreds of evidence” that support the hope that hydroxychloroquine could help patients fend off bouts of inflammation that can damage the lungs and other organs.
But researchers in the United States cautioned that the small number of patients in the studies, their hurried execution and the difficulty of assessing any drug during a medical crisis made all of the findings far from definitive. And it doesn’t help that the drugs have become political footballs, they added.
“We kind of have the red pill people and the blue pill people,” said Dr. Michael J. Ackerman, a Mayo Clinic cardiologist who was among the first to warn that the malaria drugs can dangerously disturb heart rhythms. “I don’t think either side now has the ammunition to say these drugs do or don’t work,” he added.
Yale University cardiologist Harlan Krumholz agreed. He noted that the studies, none of which has been vetted in a traditional peer-review process, “can’t exclude large effects in either direction. They leave us a little bit where we started.”
But there is a troubling signal in these and previous studies, and they create a challenge for those who would advocate use of the malaria drugs, he said.
When a drug that could be widely used poses potentially deadly dangers to the heart, “we will need a strong amount of evidence that they provide benefit,” Krumholz said. “At the moment, there is no evidence” for that, he added.
April 22, 2020 at 8:19 pm #113943znModeratorDr. Oz, on Fox & Friends, says the VA study on hydroxychloroquine shows that "we don't know" if it works and "we are better off waiting for the randomized trials Dr. Fauci has been asking for."
Just an astonishing turnaround for a network that has been aggressively promoting it. pic.twitter.com/9EzzzNAzrQ
— Matthew Gertz (@MattGertz) April 22, 2020
April 23, 2020 at 11:13 am #113958nittany ramModeratorLink: https://theness.com/neurologicablog/index.php/hydroxychloroquine-not-looking-good-for-covid-19/
We have been tracking the story of the hype surrounding hydroxychloroquine over at Science-Based Medicine, but there is a brief follow up I wanted to comment on. The short version of the story so far is that one very bad French study claimed to show dramatic reduction in detected virus in those treated. This study, however, was not only preliminary, it was a horrible study, so much so that the results are uninterpretable. The big problem was that it did not count patients who became too sick or died. That is a classic way to make a treatment look better than it is. The author is also a climate change denier who initially mocked China for taking steps to mitigate Covid-19. He does not exactly have street cred within the scientific community.
But that one horrible study from a sketchy researcher was enough to spark media hype, at least in certain circles, and capture the attention of a president apparently desperate to make this problem go away. Amid the fear of a pandemic, that was a toxic combination. The notion that hydroxychloroquine (with our without the antibiotic, azythromycin) might fight the SARS-Cov2 virus is not implausible. But most things in medicine that are “not implausible” don’t work out. We need high quality clinical science to ultimately tell.
The big question always is – what is the risk vs benefit? Hydroxychloroquine and Azythromycin both have the same potentially deadly side effect, prolonging the QT interval of the heart, which increases the risk for sudden cardiac death. This is a manageable side effect in the right setting, but is potentially serious. This is not a good drug or combination to be taking just on the chance it might help.
The entire episode is a good reason to remind everyone why science-based medicine is so important, the nature of clinical research, and the pitfalls of falling for preliminary data. After that initial terrible study there were two more preliminary studies, the kind that are done to see if there is any potential for the treatment that deserves more rigorous study. An open-label study in China found no benefit from hydroxychloroquine. There was also a French study attempting to replicate the results of the original study, and could not. They also found no benefit from the drug – no reduction in the virus, directly contradicting the original study.
But perhaps most devastating is the most recent study to show results – this was a VA retrospective study comparing patients treated with hydroxychloroquine, hydroxychloroquine + azithromycin, and just usual care. They found no benefit on any measure for those treated with the drugs. However, those treated with the drugs were twice as likely to die:
Rates of death in the HC, HC+AZ, and no HC groups were 27.8%, 22.1%, 11.4%, respectively.
That is a huge red flag, the kind of preliminary finding that could kill the prospects for a new drug. That is exactly the reason that small preliminary studies are done, to make sure the treatment isn’t killing people before doing a larger study. Even these results are not the final word, however. This is a retrospective study, which means subjects were not randomized. It is therefore possible that sicker patients were given the drugs, for example. But we can look at all the preliminary data we have so far and conclude that it’s not looking good for the prospects of hydroxychloroquine as a treatment for Covid-19. Further, this drug has a serious potential side effect that may actually increase the risk of death for those given the treatment.
Certainly, this is not the stage when this drug or combination should be hyped or recommended. It is nothing less than dangerously reckless to do so. Further, hydroxychloroquine is a proven treatment for some autoimmune diseases, like Lupus, and some patients who rely it are finding it difficult to get the drug because demand has spiked due to the hype. It’s pretty much a lose-lose all around.
At this point we do need a double-blind randomized placebo controlled trial of hydroxychloroquine in Covid-19 to get some rigorous evidence. One solid negative trial, however, should end it. If the results are promising, then further study should be done. There would be many finer questions about dose, who should get the drug, who should not get it, etc. But at this point the odds are in favor of this treatment not working out, and in fact being harmful. No one should be taking this drug for Covid-19 outside an approved clinical trial.
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