<img src = "https://cdn.arstechnica.net/wp-content/uploads/2020/04/49715506727_2e92909c8d_k-800×571.jpg" alt = "Hospital Corpsman 3rd Class Kimberly Wyss from Ventura, California, wears surgical gloves on board the hospital ship USNS grace (T-AH 19). "/>
Enlarge /. Kimberly Wyss of Hospital Corpsman 3rd Class from Ventura, California, puts on surgical gloves on board hospital ship USNS Mercy (T-AH 19).
Update, April 24: On Friday, the FDA issued a safety notice regarding the use of Hydroxychloroquine or Chloroquine, where drug use "should be limited to clinical trial settings or to the treatment of certain hospital patients. "The move was in response to a growing number of reports of" adverse events "from hospitals and outpatient treatments that affected a known side effect of chloroquine and its Derivatives: changes in heart rhythm that can be (and appear to have been) fatal.
Chloroquine is known to alter a property of the heart's electrical activity called the QT interval. If this interval becomes too long, the heart may lose its rhythm completely. When the lower chambers stop coordinated contractions, the results are fatal unless they can be restarted. A single report of successful treatment for COVID-19 had paired chloroquine with the antibiotic azithromycin, which also extended the QT interval, which led to the medication being often prescribed together.
By restricting the use of the drug to hospital environments, the FDA tries to ensure that adequate care is available if the side effects become problematic. The side effects reports he cited suggest that while there have been some deaths, there have also been non-fatal cases of potentially fatal ventricular fibrillation, suggesting that the availability of medical personnel allowed these patients to recover.
The original story follows:
A study in COVID-19 patients found no evidence that the malaria drug hydroxychloroquine, which is touted as a possible treatment for COVID-19, affects the likelihood that patients will need a ventilator. The results also indicate that patients treated with hydroxychloroquine had a higher death rate than patients who were not treated with the drug.
The study was not a randomized clinical trial, which means that the evidence offered is preliminary and should be interpreted with caution. It was also published on the medRxiv preprint server, which means that it has not yet been reviewed by experts.
However, careful interpretation of the evidence does not mean completely ignoring it. This study is one of a growing number that tells us that we don't yet know enough about hydroxychloroquine, more of an argument that we have to wait for better quality evidence from randomized controlled trials before we start using the drug widely Weight gives significant side effects.
Some small studies have given us reason to believe that chloroquine and hydroxychloroquine may have potential for the treatment of COVID-19. In some cases, the results come from experiments in cultured cells that are not necessarily directly applicable to the use of the drug in sick people. In other cases, the results come from small studies that have critical shortcomings, e.g. For example, the use of very small patient groups without a control group or the exclusion of patients who died from the analysis.
"Normally, such research is at best viewed as hypothesizing," doctors Jinoos Yazdany and Alfred Kim wrote in an opinion article in the Annals of Internal Medicine. And they were released at the same time that other early studies found no evidence that these drugs help COVID-19 patients.
However, the early hype – including the repeated promotion of President Trump – led to a runaway train of enthusiasm for the drugs. The Food and Drug Administration approved the treatment of COVID-19 patients with chloroquine and hydroxychloroquine, although there was no good evidence of their effectiveness, leading to setbacks by former FDA officials.
These drugs have a number of possible side effects, including serious heart damage. The use in critically ill COVID-19 patients therefore not only carries the risk of not helping, but also actively injuring people. The worldwide use of the medication and the resulting bottlenecks are also a problem for patients who use it for diseases such as lupus, which have been found to be effective.
A number of clinical studies are ongoing to determine whether these drugs are actually useful. In the meantime, FDA approval means that more and more data are available from patients who have been treated with them.
The US Veterans Health Administration is a national system of clinics, hospitals and other medical centers. Because it is a single organization, patient data is collected consistently, making it easier for researchers to compare apples to apples.
A research team used VHA data to track the results of confirmed COVID-19 patients in veterinary hospitals who were treated with hydroxychloroquine, hydroxychloroquine plus an antibiotic, or none of the drugs. They found that 27.8 percent of the 97 patients treated with hydroxychloroquine only died compared to 11.4 percent of the 158 patients who were not treated with hydroxychloroquine at all, and 22.1 percent of the 113 patients who died were treated with hydroxychloroquine and an antibiotic. The ventilation rates were similar in all three groups.
This evidence is weaker than a randomized controlled trial because the patients who received different treatments may initially have other important differences. In a randomized study, patients are randomly assigned different treatments (or a placebo), which means that different groups should have an approximately similar mix of people who are very sick or just a little sick, old and young, and so on.
In a retrospective study like this, doctors may have given hydroxychloroquine treatment to only the sickest patients. In this case we would expect this group to perform worse. There are ways to account for this lack of randomization in the statistical tests that researchers use to calculate risks across groups. However, with these adjustments, researchers need to figure out what other factors could complicate the analysis – a difficult challenge with a random population like this.
The patients were also not representative of the wider population. They were all men and all older than 59 years, which means that the results in younger groups or in women are not necessarily the same.
The results do not mean that hydroxychloroquine is definitely useless or that clinical trials should be discontinued. Recent NIH guidelines for physicians treating COVID-19 patients state that there is currently insufficient evidence to recommend for or against treatment with hydroxychloroquine, and that remains true.
However, they provide further evidence that we don't yet know enough to advance the use of the medication for treatment. The authors of the study acknowledge the shortcomings of their own work, but argue that the results nevertheless "emphasize the importance of awaiting the results of ongoing prospective, randomized, controlled trials before these drugs are used widely".