Today, the Federal Council of Medicine of Brazil published an official Opinion, embracing early treatment of COVID-19 patients with hydroxychloroquine and chloroquine.
Such use is to be decided at the discretion of the treating medical doctor, and with the patient’s consent.
Three criteria / scenarios are identified.
The first possibility in which the use of chloroquine and hydroxychloroquine can be considered is in the case of a patient with mild symptoms, in the beginning of a clinical diagnostic, in which other viruses (such as influenza, H1N1, dengue) have been ruled out. ) and there is a confirmed test of COVID 19.
The second hypothesis is in a patient with important symptoms, but still without the need for intensive care, with or without a recommendation for hospitalization.
The third possible scenario is in a critical patient receiving intensive care, including mechanical ventilation.
However, the Opinion points out, “it is difficult to imagine that in patients with established severe lung injury and, in most cases, with systemic inflammatory response and other organic insufficiencies, hydroxychloroquine or chloroquine may have a clinically important effect”.
The links towards the media release and official opinion, in Portuguese, are here:
To be noted also is this recent study showing a sharp reduction in the need for hospitalisation thanks to such treatment.
See below the medial release translated in English via google translate – this is obviously not an official text.
CFM conditions use of chloroquine and hydroxychloroquine at medical discretion and patient consent
Thursday, 23 April 2020 10:05
The Federal Council of Medicine (CFM) issued Opinion No. 04/2020 in which it establishes criteria and conditions for the prescription of chloroquine and hydroxychloroquine in patients with a confirmed diagnosis of COVID-19. After analyzing extensive scientific literature, the municipality reinforced its understanding that there is no solid evidence that these drugs have a confirmed effect on the prevention and treatment of this disease. However, in view of the exceptional situation and during the declared period of the COVID-19 pandemic, CFM believes that it is possible to prescribe these drugs in three specific situations.
In all situations, the principle that must, mandatorily, guide the treatment of the patient is that of the physician’s autonomy, as well as the valorization of the doctor-patient relationship, “this being the closest possible, with the objective of offering the patient the best medical treatment available at the moment ”.
Scenarios – In CFM’s view, the first possibility in which the use of chloroquine and hydroxychloroquine can be considered is in the case of a patient with mild symptoms, in the beginning of a clinical picture, in which other viruses (such as influenza, H1N1, dengue) have been ruled out. ) and there is a confirmed diagnosis of COVID 19. The second hypothesis is in a patient with important symptoms, but still without the need for intensive care, with or without a recommendation for hospitalization.
The third possible scenario is in a critical patient receiving intensive care, including mechanical ventilation. However, the Opinion points out, “it is difficult to imagine that in patients with established severe lung injury and, in most cases, with systemic inflammatory response and other organic insufficiencies, hydroxychloroquine or chloroquine may have a clinically important effect”.
In all contexts, the prescription of drugs will be the responsibility of the attending physician, in a decision shared with the patient. The CFM document emphasizes that the professional is obliged to explain to the patient that, so far, there is no scientific work, with an adequate clinical trial, done by recognized researchers and published in high-level scientific journals, which proves any benefit of the use of drugs for the treatment of COVID-19. He must also explain the possible side effects, obtaining the Free and Informed Consent from the patient or family, when applicable.
Ethical infraction – Observing these aspects, the physician who uses chloroquine or hydroxychloroquine in patients with the disease will not commit an ethical infraction. In its opinion, CFM also points out the need for constant monitoring of scientific advances in confronting COVID-19.
“These considerations that served as a basis for CFM decisions were based on current knowledge, and can be modified at any time by the Federal Council of Medicine as results of new quality research are released in the literature”, the text points out.
To reach these conclusions, CFM held meetings with representatives of different societies of medical specialties, in addition to invited researchers. The group did an extensive review of the available scientific literature on the topic.
Evidence – At the end of the work, it was concluded that “there is no robust evidence of high quality that allows the indication of a specific pharmacological therapy for COVID-19”. It has also been found that, since the end of 2019, drugs are being tested, many of them with promising results in laboratory tests and through clinical observation. Despite this, “none has yet been approved in clinical trials with a scientifically adequate design, and therefore cannot be safely recommended”.
For CFM, now, the constant monitoring of the results of studies with medicines is extremely important to periodically update the recommendations on the treatment of COVID-19. According to the document, there is a consensus among researchers from different countries that clinical trials, with an adequate design from a scientific point of view, are urgent to guide doctors on the best treatment for this disease.
There are reports that in the care of patients with COVID-19, chloroquine and hydroxychloroquine, alone or associated with antibiotics, have been used, based on the results of observational studies. However, as explained by the CFM, although there are justifications for the use of these drugs, based on their anti-inflammatory actions and against other infectious agents, their low cost and the known side effects, there are, to date, no good clinical studies. that prove its effectiveness in patients with COVID-19.
Adverse effects – However, this situation can change quickly. For example, the American Society of Infectious Diseases, in a document published on April 11, recommends that hydroxychloroquine and chloroquine, alone or associated with azithromycin, be used only in patients admitted only within clinical research protocols.
In turn, the Brazilian Society of Rheumatology (SBR), when analyzing the safety of chloroquine and hydroxychloroquine, makes some considerations, such as the description of its most common side effects: abdominal discomfort, nausea, vomiting and diarrhea. However, ocular, cardiac, neurological and skin toxicity can also occur.
Patients with psoriasis, porphyria and alcoholism may be more susceptible to adverse skin events, usually without severity. In rare cases, hemolysis may occur in patients with glucose-6-phosphate dehydrogenase deficiency. The SBR also calls for special attention to be given to interaction with other drugs, such as macrolides, quinolones, some antivirals and antipsychotics, which can lead to heart problems (enlargement of the QT interval).
Prevention – With regard to COVID-19 prevention strategies and methods, the CFM document emphasizes that the only ones recognized, so far, to prevent infection, are to reinforce hygiene and avoid exposure to the virus. There is no mention of any medication or substance for this purpose.
“Social isolation measures have been recommended worldwide as the only effective strategy to prevent the rapid spread of the coronavirus.” Thus, the overload of health systems is prevented, allowing care for patients with COVID-19, especially the most severe, who need hospitalization and ICUs.
The municipality also states that measures focused on hygiene are also highly recommended, such as washing your hands frequently; do not touch the eyes, nose and mouth with unwashed hands; avoid close contact with people; and cover your mouth and nose with your forearm when coughing or sneezing or with disposable tissues.
It is still recommended to seek medical attention immediately if the person has a fever, cough and difficulty breathing. “Early recognition of new cases is paramount for preventing transmission. Currently, it is known that undetected and asymptomatic cases are the main responsible for the high transmission rate of SARS-CoV2 ”.
In the case of patients with severe conditions, the CFM’s opinion points out that the scientific literature indicates that there is strong evidence that effective care for patients with COVID-19, with reduced mortality, is related to the provision of adequate infrastructure. Thus, the presence of doctors and health teams with adequate preparation and sufficient personal protective equipment; the existence of hospitalization and ICU beds; the presence of good quality mechanical ventilation equipment in sufficient numbers; as well as referral to intensive care, when indicated, are listed among the recommended actions.