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More and more evidence that hydroxychloroquine is not effective against COVID-19

by Cédric Ayisa - August 07, 2020   1601 Views   6 min
More and more evidence that hydroxychloroquine is not effective against  COVID-19

Claim

Hydroxychloroquine does not save the lives of COVID-19 patients

Verdict

Accurate as a whole (with reservations)

Ever since the beginning of the COVID-19 crisis, hydroxychloroquine and chloroquine have been alternatively praised and rejected by scientists and politicians alike in the fight against COVID-19. As the matter is still greatly debated on social media, we aim to show what reliable information is available. 

An article on the BBC website published on 5 June states that hydroxychloroquine "does not save lives" in the treatment of COVID-19. This statement is accurate with reservations. 

It is important to note that when this statement was made on June 5, it was unsubstantiated. As of the date of this publication, it is accurate as a whole. Our internal verdict has similarly evolved along with new proof and scientific consensus. 

A distinction to be made between the use of hydroxychloroquine for COVID-19 in hospitalized patients and for prophylaxis/post-disease management

As reported by the National Center for Biotechnoloy Information (NCBI), chloroquine is used to prevent and treat malaria and amoebiasis, while hydroxychloroquine, a less toxic metabolite of chloroquine, is used to treat rheumatic diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) and Sjogren's syndrome.

In March 2020, due to its antiviral properties and to preliminary tests conducted, researchers hypothesized that hydroxychloroquine would be as effective against COVID-19. 

Studies have been undertaken as part of several research programs on COVID-19, conducted by WHO, the European Union, England and others, to establish the effectiveness of the drug against COVID-19. These studies have focused on the use of hydroxychloroquine in a number of settings:

-clinical studies in patients hospitalized for COVID-19

-taking hydroxychloroquine for disease prevention (prophylaxis)

-post-disease intake of hydroxychloroquine

Studies are also being conducted to test the effectiveness of tandem administration of hydroxychloroquine and the antibiotic azythromicin. 

Scientific consensus on hydroxychloroquine

Several major clinical studies as well as scientific consensus have concluded that the administration of hydroxychloroquine offers no benefit to hospitalized patients with COVID-19. 

On July 4, 2020, the World Health Organization (WHO) accepted the recommendation of the International Steering Committee of the Solidarity research program to terminate clinical studies on hydroxychloroquine. The decision is based on the evidence obtained from the interim results of the Solidarity trial and a review of the evidence from all trials presented at WHO Research and Innovation Summit on COVID-19 in early July 2020. The discontinuation of WHO’s study program on hydroxychloroquine relates to the use of hydroxychloroquine in hospitalized patients and not to the use of the drug as disease prevention. 

WHO announced on May 25 the temporary suspension of hydroxychloroquine treatments in the framework of its Solidarity clinical study program. This announcement followed the publication of a study in the scientific journal, The Lancet, on 22 May 2020. The results of the research showed a high mortality rate and frequent cardiac arrhythmia in patients treated with this drug. However, WHO reversed its decision on 3 June and announced that clinical studies with hydroxychoroquine could resume. The reversal had been caused by doubts raised by other scientists about the study methodology and data used. The data came from the Surgisphere company (website now suspended), based in the United States, which claims to specialize in the analysis of health data. As the data could not be verified by an independent committee "due to confidentiality issues," Surgisphere said, the study was withdrawn by The Lancet.

In England, the preliminary findings of a study published in June by Oxford University through the RECOVERY Trial programme, an initiative of the British government, were reviewed by an independent committee. They indicate that hydroxychloroquine has "no beneficial effect on patients with COVID-19". After 28 days of treatment, the mortality rate for the group of 1,524 randomly selected COVID-19 patients was 25.7%, while the mortality rate for the 3,132 randomly selected patients who were treated as usual was 23.5%. Since the difference in the mortality rate was not significant between the two types of treatment, the researchers decided to suspend testing with hydroxychloroquine in the RECOVERY program

And even more recently, a study conducted in Brazil on more than 500 hospitalized patients with or suspected of having COVID-19 who had mild to moderate forms of the disease, and published in the Journal of New England Medicine, concluded that the use of hydroxychloroquine, with or without the antibiotic azythromicin, did not change the condition of patients compared to usual treatments. 

Hydroxychloroquine in disease prevention

The decision of WHO, of researchers from the RECOVERY program and other studies casts doubt on the effectiveness of hydroxychloroquine in general, including its use in disease prevention. A study conducted by Canadian and American universities to test the effectiveness of hydroxychloroquine in preventing COVID-19 showed no benefit. According to the results published in the New England Journal of Medicine, neither treatment with hydroxychloroquine nor treatment with placebo prevented the disease in people who had been exposed to the virus. In addition, side effects such as nausea, loose stools or abdominal pain were more present in patients treated with hydroxychloroquine than in those treated with placebo (40.1% versus 16.8%).

However, there are not yet enough studies on the use of hydroxychloroquine for the prevention of COVID-19 to stop clinical trials. We anticipate that this will change in the coming months and will publish an update in the "Update" section at the bottom of this article. Our reservations are due to the present uncertainty regarding the use of hydroxychloroquine for the prevention of COVID-19.

Compassionate and emergency use

Hydroxychloroquine is still undergoing clinical trials in some countries such as the United States, according to the Center for Disease Control and Prevention (CDC). Some researchers such as Professor Didier Raoult from France also continue to study its effectiveness but with an open clinical trial without a control group and a sample of 26 patients, their results cannot be considered reliable.

Furthermore, on June 15, 2020, the US FDA cancelled the emergency use of hydroxycloroquine and chloroquine to treat COVID-19 as a last resort. It cited the ineffectiveness of these drugs, serious adverse effects and the number of serious cardiac events to stipulate that the known and potential benefits of hydroxycloroquine and chloroquine no longer outweigh the known and potential risks of emergency use. The conclusion was the same in France, where authorities suspended the use of hydroxychloroquine in COVID19 treatments (including for compassionate and emergency use), except in clinical trials. In Belgium, the Federal Agency for Medicines and Health Products "strongly" advises against any "off-label" (no indication) use of hydroxychloroquine "outside of a clinical trial".

However, in some countries, despite controversies and the results of various studies, the use of hydroxychloroquine is still recommended. In India, it is used for prophylaxis (to prevent disease), in Senegal and in Brazil, health authorities continue to prescribe it to patients. In July, Brazilian President Jair Bolsonaro, who tested positive for coronavirus, praised hydroxychloroquine and showed himself taking the medication in a video posted on his Facebook account.

It is dangerous and harmful to promote a drug whose effectiveness has not been proven. It can lead to overdoses, unwanted side effects, and a shortage of drugs for those who really need them.

In a new context such as that of COVID-19, research is evolving and so is the urgency to act. These situations are driving scientists to change their approach and to change their position in response to new information. As for the population, it is faced with recommendations from the authorities, which change as things evolve. With respect to COVID-19, hydroxychloroquine remains, at present, a drug recommended only for clinical trials and compassionate use, at the discretion of countries. 

Our goal is to provide you with fact checks that are as accurate as and up-to-date as possible. If you think we've made an error or missed crucial information, please CONTACT US.

British Government 

https://www.gov.uk/government/news/worlds-largest-trial-of-potential-coronavirus-treatments-rolled-out-across-the-uk  

Recovery Trial 

https://www.recoverytrial.net/ 

https://www.recoverytrial.net/news/statement-from-the-chief-investigators-of-the-randomised-evaluation-of-covid-19-therapy-recovery-trial-on-hydroxychloroquine-5-june-2020-no-clinical-benefit-from-use-of-hydroxychloroquine-in-hospitalised-patients-with-covid-19 

Study Published in Brazil July 2020

https://www.nejm.org/doi/full/10.1056/NEJMoa2019014 

National Institute of Health 

https://www.covid19treatmentguidelines.nih.gov/whats-new/ 

Science direct 

https://www.sciencedirect.com/science/article/pii/S0924857920300996?via%3Dihub 

American College of Physicians 

https://www.acpjournals.org/doi/10.7326/M20-2496  

New England Journal of Medecine 

https://www.nejm.org/doi/full/10.1056/NEJMoa2016638 

World Health organization (WHO) 

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/q-a-hydroxychloroquine-and-covid-19

https://www.who.int/news-room/detail/04-07-2020-who-discontinues-hydroxychloroquine-and-lopinavir-ritonavir-treatment-arms-for-covid-19

US Food and Drug Administration 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or 

The Lancet 

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext 

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31290-3/fulltext 

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31324-6/fulltext 

Surgisphere 

https://surgisphere.com/  (Not available) 

National Center for Biotechnology Information 

https://www.ncbi.nlm.nih.gov/books/NBK537086/ 

Nature Research 

https://www.nature.com/articles/s41421-020-0156-0#Bib 

Ministère des solidarités et de la santé (France) 

https://solidarites-sante.gouv.fr/actualites/presse/communiques-de-presse/article/communique-de-presse-hydroxychloroquine-27-mai-2020 

Agence fédérale des médicaments et des produits de santé, AFMPS (Belgique) 

https://www.famhp.be/en/news/coronavirus_hydroxychloroquine_off_label_use_strongly_discouraged_and_new_benefit_risk

Science X 

https://medicalxpress.com/news/2020-05-india-hydroxychloroquine-virus.html 

https://medicalxpress.com/news/2020-05-brazil-hydroxychloroquine.html 

Government of Canada

https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/clinical-management-covid-19.html

https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals.html

COVID-19 Facts

https://www.covid19facts.ca/en/fact-checked/covid-19-dexamethasone-is-effective-in-treating-severe-cases

FDA

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/donate-covid-19-plasma/

  Claim

James Gallagher

Person
Hydroxychloroquine does not save the lives of COVID-19 patients

Verdict:

Accurate as a whole (with reservations)

 August 07, 2020


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