Enlarge /. United States President Donald Trump (L), flanked by U.S. Vice President Mike Pence, speaks during the daily briefing on the novel corona virus that causes COVID-19 on April 9, 2020 in the Brady Briefing Room in the White House in Washington. DC.
The U.S. National Institutes of Health began a clinical trial on Thursday to treat adult COVID-19 patients with hydroxychloroquine, a malaria drug that President Trump has repeatedly advertised during the pandemic, although there is no evidence of its effectiveness against the new coronavirus .
The study is one of dozens currently underway to test the drug currently used to treat malaria and rheumatoid diseases such as rheumatoid arthritis and lupus. At this point, there is only mixed, anecdotal evidence that supports its use against COVID-19.
However, this did not prevent President Trump from repeatedly promoting it as promising treatment and demanding its use. In tweets last month, Trump said that combination treatment of hydroxychloroquine and the antibiotic azithromycin "has a real chance of being one of the greatest game changers in medical history." He followed the explanation and hoped that they would be "put into operation IMMEDIATELY".
In a press conference on Saturday, April 4th, Trump continued: "I'll say it again: what do you have to lose? Take it. I really think you should take it … I think people should – if I would be – in fact I could do it anyway. I can take it. OK? I can take it. And I have to ask my doctors about it, but I can take it. "
There is no clear evidence that hydroxychloroquine – and the closely related drug chloroquine – are effective in the treatment of COVID-19. However, there is clear evidence of the risks of the medication, including headache, vomiting and rashes, vision loss (retinopathy), seizures, hypoglycemia, irregular heartbeat, and fatal heart damage. They can also pose a higher risk in patients with underlying health conditions such as diabetes and liver disease.
It is also unclear how hydroxychloroquine and chloroquine could hypothetically help fight COVID-19 infection. Early experiments with both chloroquine and hydroxychloroquine indicated that the drugs prevented the new coronavirus – SARS-CoV-2 – from infecting monkey cells grown in petri dishes. The data suggest antiviral activity, but this data is extremely preliminary to determine if a drug is effective against a virus that infects a whole person.
There is also hope that hydroxychloroquine and chloroquine could be useful in dampening out-of-control immune responses. Some critically ill patients with COVID-19 are believed to have devastating immune responses that wreak havoc on the lungs and other organs. And there is reason to believe that the drugs could help with this due to their immune-quenching effects in patients with rheumatoid diseases characterized by inflammation. Some studies have shown that the drugs thwart the action of certain receptors on human cells, which trigger cascades of inflammatory reactions. However, it is still not entirely clear how exactly the drugs interact with the immune system – or whether this would be relevant for the treatment of COVID-19.
The potential benefits of these drugs against COVID-19 are currently under investigation in numerous clinical trials, including the NIH trial, which is ongoing this week.
The NIH study is a blind, randomized, placebo-controlled experiment that aims to enroll 500 adult COVID-19 patients who have been hospitalized or receiving emergency care and are expected to be hospitalized. Researchers will give people randomized to the treatment group two doses of hydroxychloroquine a day for five days. They then track patient results and examine future hospital status, the need for oxygen or invasive mechanical ventilation, and death.
The first patients were admitted to the Vanderbilt University Medical Center in Nashville this week. It is one of dozens of medical centers on a network organized by the NIH's National Heart, Lung, and Blood Institute (NHLBI).
Given the unbridled excitement surrounding hydroxychloroquine – supported by President Trump – the researchers involved in the study are feeling the pressure to get results as soon as possible.
"Many US hospitals are currently using hydroxychloroquine as a first-line treatment for hospitalized COVID-19 patients, although the effectiveness of clinical data is extremely limited," said Dr. Wesley Self, an emergency physician at Vanderbilt University Medical Center, who leads the study in a statement. "Therefore, hydroxychloroquine data for the treatment of COVID-19 is urgently needed to inform clinical practice."
Amid Trump's drive for hydroxychloroquine, the Food and Drug Administration issued an emergency approval late last month that allows doctors to treat patients with COVID-19. The unusual move led to significant setbacks by former FDA officials, the science magazine reported.
In addition, Trump's enthusiasm for the drug is said to have prompted him to advance the disease control and prevention centers on the matter. The agency then released an unprecedented guide in which doctors were informed, based on anecdotal data, how to prescribe chloroquine and hydroxychloroquine for COVID-19.
According to Dr. Peter Lurie, a doctor and former FDA manager under Obama and Trump who spoke to Science, says the risk of side effects is widespread. “What is quite certain is that if a large number of people (hydroxychloroquine) are exposed, there are important adverse effects. This may be acceptable when setting known benefits, but is more difficult to accept if it is not and there may never be any benefit, ”he said. Lurie is now head of the Center for Science advocacy in the public interest.
Experts also fear that the availability of the drugs could undermine clinical trials trying to get this evidence. The availability of the drug could potentially prevent patients from participating in trials that randomly placebo, rather than promising treatment that is already available.
In addition, there is growing concern that increasing interest in these medicinal products will lead to life-threatening shortages in patients with rheumatoid diseases such as lupus who rely on them to achieve proven benefits.
Along with all of the concerns, play and recoil have increased. In a statement on March 31, the researchers asked their colleagues to protect patients with rheumatoid diseases and to avoid the misuse of hydroxychloroquine and chloroquine. They added: "Public figures should refrain from making unproven therapies known to the public, and instead deliver clear messages about the uncertainties we face when testing and using experimental treatments during the current pandemic, including the risk of more serious ones adverse events. "
Earlier this week, Reuters reported that the CDC removed the unusual guidelines for doctors treating COVID-19 patients. The CDC website now correctly states: "There are no drugs or other therapeutic agents approved by the United States Food and Drug Administration to prevent or treat COVID-19."
Criticism of a very small, flawed French study claiming that a combination of hydroxychloroquine and azithromycin could treat COVID-19 has also continued, a Trump-sponsored study. Among other things, the study discarded data on participants who worsened during treatment, including three ICU participants, one who dropped out of the study due to side effects, and one who died.
In a first statement on April 3, the medical society behind the journal that published the study said that the company shares "concerns" about the article that "does not meet society's expected standard". The company later updated the statement to determine that the study is undergoing an additional review and indicated that the study may be withdrawn entirely after the review is completed.
The NIH study and dozens of other studies attempt to provide solid data on the use of hydroxychloroquine and chloroquine for COVID-19. These include an international study organized by the World Health Organization called a solidarity study to test the drugs, and three other treatment candidates.