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Most promising studies on Hydroxychloroquine and Chloroquine (COVID-19)

What is a clinical trial? The answer is in my Youtube video above at 0:44 (1) Why Hydroxychloroquine and Chloroquine have become so interesting for COVID-19?  In laboratory experiments, both…

By thepharmacoach

Apr 22, 2020

What is a clinical trial?

The answer is in my Youtube video above at 0:44 (1)

Why Hydroxychloroquine and Chloroquine have become so interesting for COVID-19? 

In laboratory experiments, both chloroquine and hydroxychloroquine have been reported to neutralize SARS-CoV-2 which is the virus that causes the disease COVID-19 . Hydroxychloroquine has shown to be more powerful in the lab than chloroquine to inhibit the virus. The way they neutralize the virus is still unknown. As for right now, one of the suspected ways is that these agents change the pH of the cell membrane. This pH change would prevent the virus from binding to your cells and entering them. (2)

Fun fact: The interest for these drugs in viral infections is not new. During the last decade, they were at the center of a few studies on HIV/AIDS, SARS, Dengue and Ebola.

For more details on these studies, click on these links:

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(06)70361-9/fulltext 

https://www.liebertpub.com/doi/full/10.1089/jir.2014.0038

https://orca.cf.ac.uk/92762/1/Akpovwa-2016-Cell_Biochemistry_and_Function.pdf 

First trial on hydroxychloroquine (France): (Youtube video above at 4:14)

  • Study abstract : 

https://www.mediterranee-infection.com/wp-content/uploads/2020/03/Hydroxychloroquine_final_DOI_IJAA.pdf

  • Preliminary trial
  • Participants: 36 hospitalized COVID-19 patients 
  • Groups:
    1. 20 patients receiving hydroxychloroquine (including 6 patients receiving Hydroxychloroquine + an antibiotic called Azithromycine) 
    2. 16 patients not receiving hydroxychloroquine (control group)
  • Results: 
    1. At day 6, 70% of the hydroxychloroquine group tested negative for the virus.
    2. At day 6, 12% of the control group tested negative
    3. At day 6, 100% of the patients who received Azithromycin and Hydroxychloroquine tested negative. 

*** Considering that antibiotics treat bacterial infections, why an antibiotic (Azithromycine) was used to treat a viral infection (COVID-19)? 

The answer is in my Youtube video above at 

  • Limitations of this study
    • Small group of patients
    • Not randomized
  • To know what is a randomization and why it’s important, click on video above at 6:22

Because of these preliminary promising results with hydroxychloroquine and azithromycin, more research is being done , on a bigger scale.

There’s a clinical trial happening in Brazil that is looking to answer if the association of hydroxychloroquine and azithromycin is more effective than hydroxychloroquine alone.

Clinical trial description:

https://www.clinicaltrials.gov/ct2/show/NCT04321278?term=Hydroxychloroquine&recrs=adf&cond=covid-19&phase=123&draw=2&rank=8

In Europe, there’s an ongoing Phase 3 Study called Discovery. It will involve around 3000 hospitalized patients with severe COVID-19 patients, including 800 in France. The goal with this trial is to evaluate and compare the efficacy and safety of 5 different experimental COVID-19 treatments. The compared treatments are Remdesivir vs Lopinavir/Ritonavir vs Interferon Beta-1A vs Hydroxychloroquine vs Standard of care.

https://clinicaltrials.gov/ct2/show/NCT04315948?term=discovery&cond=COVID-19&draw=2&rank=1

In Canada and the USA, these drugs do not have an official use for COVID-19 but they have been approved only  for clinical trials

The FDA issued an emergency use authorization (EUA) to allow the use of both drugs (hydroxychloroquine or chloroquine) for hospitalized COVID-19 patients who are not eligible for clinical trials and for which these drugs are safe.

FDA emergency use authorization:(Youtube video above at 9:05)

https://www.fda.gov/media/136538/download (hydroxychloroquine)

https://www.fda.gov/media/136536/download (chloroquine)

Currently there is a phase 4 clinical trial being held in the US that will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19.

Clinical trial description:

https://www.clinicaltrials.gov/ct2/show/NCT04334967?term=Hydroxychloroquine&recrs=adef&cond=covid-19&phase=123&draw=2

In Canada, particularly in the province of Quebec where I live, Quebec pharmacists now have the temporary obligation to stop treatments of chloroquine and hydroxychloroquine for patients with certain conditions. If you want more details about this obligation (why and which condition), click on Youtube video above at 10:40.

Here is the collective national prescription (only available in french): 

https://www.inesss.qc.ca/fileadmin/doc/INESSS/COVID-19/COVID-19_OC-PMN_HCQ.pdf

China has completed a hydroxychloroquine trial in China. The goal was to evaluate the efficacy and safety of hydroxychloroquine in the treatment of pneumonia caused by COVID-19. 

Clinical trial description:

https://www.clinicaltrials.gov/ct2/show/NCT04261517?term=Hydroxychloroquine&recrs=adef&cond=covid-19&phase=123&draw=2&rank=12

Unfortunately this trial is not very reliable because it was very small around (30 patients) and doesn’t really reveal anything. We obviously must wait for the results of the larger trials that are being conducted in China. 

As for Italy,  for the moment, there is no published Italian data on the use of hydroxychloroquine or chloroquine even though Italian recommendations indicate the use of hydroxychloroquine for COVID-19. (3)

Concerning the use of hydroxychloroquine for COVID-19 prevention:

There are 2 clinical trials looking to evaluate the efficacy of hydroxychloroquine to prevent COVID-19 among healthcare workers. There is a Phase 3 trial in Spain with over 4000 participants. 

Description of Phase 3 clinical trial in Spain:

https://www.clinicaltrials.gov/ct2/show/NCT04334928?term=Hydroxychloroquine&recrs=adf&cond=covid-19&phase=123&draw=2&rank=9

Description of Phase 2 clinical trial in US:

https://www.clinicaltrials.gov/ct2/show/NCT04333225?term=Hydroxychloroquine&recrs=adf&cond=covid-19&phase=123&draw=2&rank=1

For post-prophylaxis, there’s a collaboration study between Canada and the US.

https://www.clinicaltrials.gov/ct2/show/NCT04308668?term=Hydroxychloroquine&recrs=adf&cond=covid-19&map_cntry=CA&phase=123&draw=2&rank=2 

There are fewer trials on chloroquine. Why? The answer is in my Youtube video above at 12:53

However, chloroquine is in the chinese guidelines for the management of COVID-19.

https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30093-X/fulltext

We have two phase 2  trials for chloroquine that haven’t started recruiting. 

There is one  that’s supposed to take place in Israel involving patients with mild COVID-19 symptoms.

https://www.clinicaltrials.gov/ct2/show/NCT04333628?term=Chloroquine&recrs=abdef&cond=covid-19&phase=0123&draw=2&rank=1 

There’s one in Vietnam targeting hospitalized COVID-19 patients.

https://www.clinicaltrials.gov/ct2/show/NCT04333628?term=Chloroquine&recrs=abdef&cond=covid-19&phase=0123&draw=2&rank=1 

There is a Phase 2 trial taking place in Brazil. They’re currently recruiting patients to evaluate the efficacy of Chloroquine to treat hospitalized patients with severe COVID-19 symptoms.

https://www.clinicaltrials.gov/ct2/show/NCT04323527?term=Chloroquine&recrs=adef&cond=covid-19&phase=0123&draw=2&rank=2

For more complete information, feel free to watch my Youtube video above. 

Let’s keep in mind that there are currently other treatments that are under investigation such as vaccines, antivirals including some HIV medications and other medications used for inflammatory conditions. I also made a youtube video on these: https://www.youtube.com/watch?v=AGXebyG8dgI

Other references:

  1. https://www.who.int/ictrp/glossary/en/#TrialPhase
  2. https://www.ncbi.nlm.nih.gov/pubmed?term=32150618
  3. https://www.medscape.com/viewarticle/927758?nlid=134829_2049&src=WNL_mdplsnews_200403_mscpedit_imed&uac=251833FN&spon=18&impID=2334280&faf=1

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