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Two new studies, published in the respected British scientific journal The BMJ, again found no evidence that the use of hydroxychloroquine benefits Covid-19 patients, including those with mild and moderate cases.
Also, again, the researchers found adverse effects on the use of the drug.
Two other large, recent studies published in the renowned journals The New England Journal of Medicine and Jama (Journal of the American Medical Association) also found no reduction in deaths and intubation in Covid-19 patients who received hydroxychloroquine and azithromycin. These surveys analyzed data from more than 1,000 patients.
One of the surveys published on Thursday (14) was carried out in China with 150 patients with Covid-19 (of which only two were serious cases), between February 11 and 29, in 16 health units in the country, distributed in Hubei provinces. (starting point of the pandemic), Henan and Anhui. The authors state that this is the first randomized, controlled study to analyze the use of hydroxychloroquine against Covid-19.
However, the research is open: there are no “blind” groups that do not know if they are really taking the drug or a placebo, to avoid possible biases.
Among the patients, 75 received hydroxychloroquine (1,200 mg for three days and 800 mg daily for up to three weeks, depending on the case) plus standard symptomatic treatment. The other 75 underwent standard treatment only.
The researchers assessed whether Sars-CoV-2 persisted in the patients. For that, they used PCR tests in the evaluation of patients and then on days 4, 7, 10, 14, 21 and 28. When two consecutive tests, with a difference of 24 h, were negative and none of the following tests were positive The virus was considered to be no longer present. In addition, vital patient data was also collected.
109 patients were found to be negative for Sars-CoV-2 well before the 28 days determined in the study. Of these, 56 were part of the control group (who received standard treatment) and 53 had received hydroxychloroquine in addition to normal care.
Therefore, according to scientists, the probability that within 28 days people would have been negative for the virus was 85% in the group receiving hydroxychloroquine and 81% in the standard treatment group, that is, a result Similary.
According to Chinese researchers, the results did not indicate that hydroxychloroquine, combined with standard treatment, will bring benefits in removing the virus from the person’s body.
They also noted more gastrointestinal adverse events in the patients who received the drug.
Another study on hydroxychloroquine also published this Thursday in The BMJ and observational, that is, it uses previous care data, has not observed an effect of the drug to reduce the need for intensive care or reduce deaths after 21 days of starting treatment.
In it, French researchers analyzed data from 181 patients with severe Covid-19 conditions, who needed help with oxygen to breathe but were not in the ICU. The information is derived from four French medical centers.
Then, the survival of people without the need for admission to the ICU was analyzed.
Two treatment strategies were observed in the study. In one, 84 patients received a daily dose of 600 mg of hydroxychloroquine, and in the other, 89 were part of the control group, that is, those who did not receive the medication. People were followed until they died, were discharged, or until the end of the analysis, on April 24.
The group of patients in the intervention group (who had fewer associated diseases) received hydroxychloroquine within 48 hours after hospital admission.
The data show similarities in performance between the two patient groups. Considering possible imbalances between the groups, the researchers calculated that of the patients who received the test medication, 76% survived without the need to be transferred to intensive care. In the control group, the number was 75%. Progression-free survival levels for acute respiratory distress syndrome were 69% for those taking hydroxychloroquine, 74% for those who did not receive the medication. Finally, overall survival was 89% and 91%, respectively, after 21 days.
“Our results suggest that patients with fewer symptoms and a better prognosis on admission do not respond better to the use of hydroxychloroquine,” say the French researchers.
Drug-related adverse effects were again found. Among the 84 who took the drug, eight (representing 10%) had changes in their electrocardiograms and therefore had to stop treatment.
According to French scientists, it can be argued that when starting treatment with the drug can make a difference in the final image. However, the patients analyzed, at the time of inclusion in the study, had symptoms, on average, for seven days, that is, a short time. Still, they argue that the possibility should be explored in future studies.
The fact that the French study is observational is an important limitation. Larger, double-blind (where patients and clinicians do not know what they are taking or prescribing), randomized (as first reported here), and a control group (such as both present in this report) studies provide a higher level of evidence.
Even without studies proving the efficacy of chloroquine and hydroxychloroquine against Covid-19, President Jair Bolsonaro (without a party) continues to treat the drug as a solution to the pandemic and is now pressuring Health Minister Nelson Teich for El Ministry of Health adopts a protocol for the use of chloroquine in patients with early stages of the new coronavirus.
In a conference call with big businessmen organized this Thursday, Bolsonaro said that the current protocol, which supports the use of the drug for critical and serious cases, “can and will change.”
“Now they voted for me to decide and this problem with chloroquine passes through me. Everything is fine with the Minister of Health [Teich], without any problem, I believe in his work. But we will solve this chloroquine problem, “said the president.
Regarding the use of hydroxychloroquine against the new coronavirus, Teich has an evaluation similar to that of the former minister, Luiz Henrique Mandetta (the problems related to social isolation and chloroquine were some of the factors responsible for the confrontation between Bolsonaro and the former minister ).
“Chloroquine today remains an uncertainty. There were initial studies that suggested benefits, but today there are studies that say otherwise,” the minister said on April 29. “Preliminary data from China indicates that it had high mortality and that the drug will not be a turning point in relation to the disease.”
On Twitter, Teich also warned about the risks of using the drug: “Chloroquine is a drug with side effects. Therefore, any prescription must be made based on a medical evaluation. The patient must understand the risks and sign the ‘Form of consent ‘before starting to use chloroquine. “
