https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771265

This randomized clinical trial did not detect a reduction in SARS-CoV-2 transmission with prophylactic administration of hydroxychloroquine, and all participants who did contract SARS-CoV-2 were either asymptomatic or had mild disease courses with full recoveries. As such, we cannot recommend the routine use of hydroxychloroquine among HCWs to prevent COVID-19.

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September 30, 2020

Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care WorkersA Randomized Clinical Trial

Benjamin S. Abella, MD, MPhil1; Eliana L. Jolkovsky, BA1; Barbara T. Biney, MPH1; et al

NO BENEFIT

Early results of Hydroxychloroquine in treatment of COVID-19 are not encouraging.

We have to wait for early results WHO-sponsored SOLIDARITY trial to have a definitive conclusion.

https://www.acc.org/latest-in-cardiology/journal-scans/2020/05/08/14/03/observational-study-of-hydroxychloroquine

https://www.sciencemag.org/news/2020/03/who-launches-global-megatrial-four-most-promising-coronavirus-treatments

Because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients". It is a preprint Paper has been peer reviewed.

the dosage is very high and gastroenteric intolerance was absolutely predictable for those who know the drug for clinical use in rheumatology.

Here you can read another preprint paper not peer reviewed that use low dosage without side effects with completely opposite results .

https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v3

Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial

Zhaowei Chen, Jijia Hu, Zongwei Zhang, Shan Jiang, Shoumeng Han, Dandan Yan, Ruhong Zhuang, Ben Hu, Zhan Zhang

medRxiv 2020.03.22.20040758; doi:https://doi.org/10.1101/2020.03.22.20040758

I think we have to wait The largest phase 3 placebo-controlled trial with anticipated enrollment of 1300 participants conducted by researchers at the University Hospital, Angers, France.

Dear Antonella,

In my opinion, the mechanism of action of hydroxychloroquine (HCL) should still be reliably proven to justify its clinical use. Currently, it is widely believed that it changes microenvironmental pH affecting the penetration of coronavirus. However, an alternative mechanism affecting capturing porphyrin in hemoglobin has also recently been proposed.

In France, the use of anti-malarial drugs chloroquine and HCL has been insisted by prof. Raoult from Marseille. Many specialists disagreed with him, claiming that his clinical studies do not reflect a real effect, since no comparisons have been performed with a randomly selected control group of patients. A few days ago, the first reliable results, obtained in other hospitals in France, do not confirm the benefits of hydroxychloroquine. A comparative study of 84 patients with COVID-19 who needed oxygen and received HCL (600 mg per day), and 97 similar patients who did not receive the drug (control group) showed that transfer to the intensive care unit or death from any cause within 7 days did not differ significantly between two groups (approximately 21% -22% of patients). Moreover, eight patients who received HCL (9.5%) had electrocardiogram changes requiring discontinuation of HCL therapy. These results do not support the use of HCL in patients hospitalized with a diagnosis of SARS-CoV-2 (preprint “No evidence of clinical efficacy of hydroxychloroquine in patients hospitalized for COVID-19 infection and requiring oxygen: results of a study using routinely collected data to emulate a target trial" published in medRxiv from 18/04/2020).

Let's wait for the results from other European centers currently engaged in a large-scale study of several drugs already clinically tested for other infections.

Regarding Covid 19 therapies , at the moment, there is no evidence of efficacy confirmed by randomized controlled clinical trials with adequately significant numbers of patients for any of drugs currently available. In the course of pandemic it is unethical to think of treating some patients with a potentially effective drug and others with placebo. It makes all more difficult especially when the outbreak advances and time goes on. Therefore several published clinical studies didn’t have strong evidence of efficacy . People die in a short time and intensive care units are full. Non-intensive hospitalizations are being set up but patients are increasing day by day. Many doctors died too.. In this setting an ideal drug available for using in a large population should have a rationale of efficacy, side effects already known because already employed for other indications in rheumatology, easy to do and low cost. Too much to put it all together ... yet from this analysis at the moment the available drug that brings them all together is called IDROSSICLOOCHINA . The interesting role of hydroxychloroquine may be not the antiviral activity but the immunomodulation in a early stage of covid 19. On march 17th AIFA approved the off label use of hydroxychloroquine for covid 19 in italy and many general practitioners started to use this drug for treatment of not severe ill covid patients at home .In the last weeks the hospitalizations decreased and especially acute ill patients admitted in critical unit decreased. Now we can wait for the results of currently randomized controlled large-scale studies of several drugs (including hydroxychloroquine) for fighting the outbreak all over the world.

In fact, for placebo, patients receive general treatment to reliably compare the effects of hydroxychloroquine. In Sweden, the drug was withdrawn from therapy due to the deterioration of the patient’s health. Some doctors question acute pneumonia as the main symptom; apparently, coronavirus also affects other organs. In France, we are also observe a transition of infection to a plateau, regardless of HCL therapy.

Currently, some other drugs have shown promising results in small groups of patients in the clinic. But I do not think that such drugs can provide the expected effectiveness. We need specific drugs for SARS-CoV2 under development. Unfortunately, much more time is required to undergo rigorous preclinical and clinical trials.

I agree therefore, if a clinically approved drug for another disease (like HCL and others) gives a positive effect against coronavirus, it can be used by decision of a doctor within the framework of the country's medical rules.

Lee SH, Son H, Peck KR. Can post-exposure prophylaxis for COVID-19 be considered as one of outbreak response strategies in long-term care hospitals? [published online ahead of print, 2020 Apr 16]. Int J Antimicrob Agents. 2020;105988. doi:10.1016/j.ijantimicag.2020.105988

If you are interested in funding your research go to free Virtual Partnering Event at

https://virtual-partnering.com

Good chance

I prefer to wait the results of the many studies that are ongoing .

I don’t understand what is the rational for using very hight dosage of hydroxichororquine in the TRIAL RECOVERY

Hydroxychloroquineby mouth for a total of 10 days as follows

Initial dose 800 mg

6 hours after initial dose 800 mg

12 hours after initial dose 400 mg

24 hours after initial dose 400 mg

Every 12 hours thereafter for 9 days 400 mg

The same hight dosage is applied in SOLIDARITY the megatrial of WHO

Toxic-pharmacological data and the clinical activity of chloroquine, given its worldwide use, are unquestionably acquired; chloroquine is reported on all official texts and is therefore to be considered a well-established drug.

Acute chloroquine intoxication (after high overdoses of 2-5 g) can cause death within 1-3 hours as a result of cardiocirculatory and respiratory arrest. ( the RECOVERY dosage of 1600 mg is very close to 2 grams)

Despite I use this drug every day and I'm sure that has a good safety profile and a good ration for using aganist SARS COV 2 , I would be afraid to recruit patients for these two studies.

Moreover, this high dosage could not be used on a large population . So what is the goal of these trials ?

Watson J et al. An open letter to Mehra et al and The Lancet. Zenodo 2020 May 28. Doi: https://doi.org/10.5281/zenodo.3862789

The Lancet published an Expression of Concern on the paper by Mehra et al on hydroxychloroquine and chloroquine published on May 22, 2020 https://hubs.ly/H0r2vFC0 Published:June 03, 2020DOI:https://doi.org/10.1016/S0140-6736(20)31290-3

Antonella Marcoccia Please check this out; it's not hcq, but my question more concerns the test results vs. what you know about hcq testing. This material seems at least as dangerous as that alleged for hcq. Why the difference in reception by the medical community?

https://www.medrxiv.org/content/10.1101/2020.06.22.20137273v1

https://en.wikipedia.org/wiki/Hydroxychloroquine#COVID-19

There is no strong scientific evidence to support the use of hydroxychloroquine for preventing or treating coronavirus disease 2019 (COVID‑19).[3][4][52][53] While its use is not approved by the FDA for COVID‑19 treatment, from April to June 2020, there was an emergency use authorization for its use in the United States,[54] and it has been used off label for potential treatment of the disease.[55] On 24 April 2020, citing the risk of "serious heart rhythm problems", the FDA posted a caution against using the drug for COVID‑19 "outside of the hospital setting or a clinical trial".[56] On 15 June, the FDA revoked its emergency use authorization, stating that it was "no longer reasonable to believe" that the drug was effective against COVID-19 or that its benefits outweighed "known and potential risks".[50][57][58][59]

On 29 May 2020, the European Medicines Agency (EMA) published a list of references of observational studies of chloroquine and hydroxychloroquine in people with COVID‑19.[60]

A randomized, double-blind, placebo-controlled study of hydroxychloroquine in 821 participants found that it did not treat COVID‑19 infection, although the study had limitations.[61][62] In June, use of hydroxychloroquine in the UK RECOVERY Trial was discontinued when an interim analysis of 1,542 treatments showed it provided no mortality benefit over 28 days to people hospitalized with severe COVID-19 infection.[51]

In 2020, during the COVID-19 pandemic, there was a discussion in a number of countries about the feasibility of using hydroxychloroquine to treat this disease. In particular, the use of hydroxychloroquine was advocated by US President Donald Trump. There was a scandal around the evidence and denials of the drug's efficacy due to falsification of scientific data[1].

In April 2020 the Russian Ministry of Health included this drug in the list of possible drugs for the treatment of COVID-2019 in adults[2]. In the USA earlier (on March 28, 2020) the FDA issued an "emergency use authorization" (EUA), which allowed the use of hydroxychloroquine to treat COVID-19 despite the lack of evidence of its effectiveness against the causative agent of this disease[3].

Hydroxychloroquine, like chloroquine, causes serious side effects. By June 2020, the accumulated clinical experience has shown that both known and potential benefits of both drugs do not outweigh the known and probable risks for their use. The U.S. Biomedical Advanced Research and Development Authority (BARDA) initiated the revocation of the "emergency use exemption" for these drugs in the treatment of COVID-19. On June 15, 2020 the FDA removed chloroquine and hydroxychloroquine from the list of drugs allowed for treatment of COVID-19[4][5][3]. Despite this, the Ministry of Health of the Russian Federation decided not to exclude it and in version 8 of the clinical recommendations for treatment of COVID-19 the hydroxychloroquine therapy is prescribed[6][7].

https://ru.wikipedia.org/wiki/%D0%93%D0%B8%D0%B4%D1%80%D0%BE%D0%BA%D1%81%D0%B8%D1%85%D0%BB%D0%BE%D1%80%D0%BE%D1%85%D0%B8%D0%BD