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https://www.fiercepharma.com/pharma-asia...t-clinical

Quote:First, in a small study involving 30 patients, hydroxychloroquine, used on top of conventional treatments, cleared the virus in 13 (86.7%) cases on day 7, while 14 (93.3%) patients in the control group had the virus cleared, according to a study abstract Raffat obtained. One patient on the malaria med progressed to severe during the treatment.

The median duration from hospitalization to virus-negative testing, as well as the median time to body temperature normalization, were also similar between the two arms. The only positive signal was disease progression shown on CT scans, which five hydroxychloroquine cases showed, versus seven in the control group. But Raffat said the trial size was simply too small to draw conclusions.


On the other hand...

https://www.thelancet.com/journals/langl...5/fulltext


Quote:Clinical trials of hydroxychloroquine treatment for COVID-19 pneumonia are underway in China (NCT04261517 and NCT04307693). We are reviewing the results from China as they emerge. The first study (NCT04261517) has showed positive preliminary outcomes (albeit not conclusive because of the small sample size) in terms of clinical management, with published data expected soon.

I look forward to seeing some of these results.

BC
There is also one unauthorized study of using chloroquine phosphate to combat Covid-19.  It was found to be fatal.
(03-24-2020, 01:48 PM)martyup Wrote: [ -> ]There is also one unauthorized study of using chloroquine phosphate to combat Covid-19.  It was found to be fatal.

Might have been a GMP issue.

BC
(03-24-2020, 01:55 PM)BostonCard Wrote: [ -> ]
(03-24-2020, 01:48 PM)martyup Wrote: [ -> ]There is also one unauthorized study of using chloroquine phosphate to combat Covid-19.  It was found to be fatal.

Might have been a GMP issue.

BC

Not at all.  It works perfectly for cleaning aquariums.  More of a DMF issue.
(03-24-2020, 02:00 PM)martyup Wrote: [ -> ]
(03-24-2020, 01:55 PM)BostonCard Wrote: [ -> ]
(03-24-2020, 01:48 PM)martyup Wrote: [ -> ]There is also one unauthorized study of using chloroquine phosphate to combat Covid-19.  It was found to be fatal.

Might have been a GMP issue.

BC

Not at all.  It works perfectly for cleaning aquariums.  More of a DMF issue.

I assume that in this case, you are not referring to a Drug Master File with the FDA but an alternate, more Urban Dictionary meaning for DMF.  

Cheers,
Pete F.
(03-24-2020, 02:49 PM)pefloresjr Wrote: [ -> ]
(03-24-2020, 02:00 PM)martyup Wrote: [ -> ]
(03-24-2020, 01:55 PM)BostonCard Wrote: [ -> ]
(03-24-2020, 01:48 PM)martyup Wrote: [ -> ]There is also one unauthorized study of using chloroquine phosphate to combat Covid-19.  It was found to be fatal.

Might have been a GMP issue.

BC

Not at all.  It works perfectly for cleaning aquariums.  More of a DMF issue.

I assume that in this case, you are not referring to a Drug Master File with the FDA but an alternate, more Urban Dictionary meaning for DMF.  

Cheers,
Pete F.
Affirmative Pete.  It reminds me of the urban legend story of a lady who had cruise control on her new Winnebago and engaged it while she went to the galley to make a sandwich.  Although she survived the ensuing accident and was, fortunately, over the age of reproduction, she was able to find a lawyer to successfully sue Winnebago for failing to warn her that cruise control was not autopilot.

(03-25-2020, 01:45 PM)martyup Wrote: [ -> ]This man disagrees:

https://www.westernjournal.com/coronavir...aved-life/

I'd put more weight on a controlled trial than an anecdote on a right-wing political web site.
(03-25-2020, 01:45 PM)martyup Wrote: [ -> ]This man disagrees:

https://www.westernjournal.com/coronavir...aved-life/

This is why we have randomized, placebo controlled trials.  If it really saved his life, then it ought to save the lives of other people like him.  And if it saves the lives of other people like him, then patients given chloroquine as part of a study will do better than patients in the same study who were given placebo.

BC
(03-25-2020, 01:45 PM)martyup Wrote: [ -> ]This man disagrees:

https://www.westernjournal.com/coronavir...aved-life/
Anecdotes ≠ data
BC, the study NCT04261517 is the one reported on yesterday.  The other study of 150 patients, comparing HCQ versus Lopinavir/ritonavir, is in phase 2.

I'm surprised Laurie Garrett, with good credentials, would jump on one small study (which seems flawed to me) and declare "nada" when there was another study of about the same size (and seemed flawed to me too) that seemed to have different results. 

30 treatment-naÏve patients, split randomly into a test group of 15 and a control group of 15.

I had to use Google Translate to pull some of the tabular results out    It indicates "Mean course of the disease" (I presume time since first symptom?) was 6.6 days for test group, 5.9 for control.  It indicates 9 of the test group had a fever while 13 of the control group had a fever.  That seems a bit odd to me.

The trail seems to only take one subsequent test for the virus, at 7 days, where 90% of all patients were without the virus.  That's not much room for discrimination.  That was the study's primary endpoint.

Only 1(in the test group) of the 30 became severe.  That's odd.   3% here versus 16% in the 1099-patient study.  Better outcome due to improved care?  How?

The test group median age was about 4 years older. (50.5 vs 46.7) which would bias things for worse outcome for the test group.
The test group had 5 of the 15 with hypertension, versus 3 in the control group.  The control group had one person with COPD. (Each group had one with diabetes.)
Overall 11 coexisting conditions (36%, 40% test group, 27% control group) compared to 24% in the 1099-patient study).

To me, the jury is still out.  My hopes are down though.
(03-25-2020, 01:55 PM)burger Wrote: [ -> ]
(03-25-2020, 01:45 PM)martyup Wrote: [ -> ]This man disagrees:

https://www.westernjournal.com/coronavir...aved-life/
Anecdotes ≠ data

That's not true; it's not an anecdote, it is artisanal data.

(03-25-2020, 01:56 PM)M T Wrote: [ -> ]BC, the study NCT04261517 is the one reported on yesterday.  The other study of 150 patients, comparing HCQ versus Lopinavir/ritonavir, is in phase 2.

I'm surprised anyone with any credentials would jump on one small study (which seems flawed to me) and declare "nada" when there was another study of about the same size (and seemed flawed to me too) that seemed to have different results. 

30 treatment-naÏve patients, split randomly into a test group of 15 and a control group of 15.

I had to use Google Translate to pull some of the tabular results out    It indicates "Mean course of the disease" (I presume time since first symptom?) was 6.6 days for test group, 5.9 for control.  It indicates 9 of the test group had a fever while 13 of the control group had a fever.  That seems a bit odd to me.

The trail seems to only take one subsequent test for the virus, at 7 days, where 90% of all patients were without the virus.  That's not much room for discrimination.  That was the study's primary endpoint.

Only 1(in the test group) of the 30 became severe.  That's odd.   3% here versus 16% in the 1099-patient study.  Better outcome due to improved care?  How?

The test group median age was about 4 years older. (50.5 vs 46.7) which would bias things for worse outcome for the test group.
The test group had 5 of the 15 with hypertension, versus 3 in the control group.  The control group had one person with COPD. (Each group had one with diabetes.)
Overall 11 coexisting conditions (36%, 40% test group, 27% control group) compared to 24% in the 1099-patient study).

To me, the jury is still out.  My hopes are down though.

To be clear, I didn't jump on one study as dispositive (I didn't even read it until you pointed it out, because, other than being the first randomized trial, I would not consider it to be high quality).  Indeed, the conclusion of the study "Larger sample size study [sic] are needed to investigate the effects of HCQ in the treatment of COVID-19".  A thirty patient study with an endpoint of RT-PCR clearance of virus is not much evidence it doesn't work, other than the fact that you can probably rule out a massive effect (I'm talking an effect the size of the early penicillin "trials", which were not randomized or placebo controlled, but for which the effect was so obvious as to be unambiguous).  But I think we would all call a drug "successful" if it resulted in a reduction in the need for ventilators among patients admitted to the hospital from 30% to 20% or cut mortality among hospitalized patients from 10% to 5%, which is something you need a much bigger study to evaluate.

My point was just to jump on the "chloroquine cured me" case report published in the prestigious journal The Western Journal.  That is even less credible than an under-powered negative study.

BC
Why would anyone resist trying something that may save lives?  Under a Dr's supervision this medication has little downside re side effects.  Dr. Fauci recommends prescribing it to severe cases.  I trust him more than some tweet saying "nada."

Oh, and now we are trusting "controlled" studies from China?
(03-25-2020, 01:45 PM)martyup Wrote: [ -> ]This man disagrees:

https://www.westernjournal.com/coronavir...aved-life/

There's a reason you do studies on these things.

Sometimes people just get better. There's a reason why, before modern scientific medicine, people believed all kinds of crazy things helped them (and why people still do, despite all evidence to the contrary).

Maybe this helped and maybe it didn't, but one guy pulling through after getting it tells you virtually nothing.
(03-25-2020, 02:11 PM)martyup Wrote: [ -> ]Why would anyone resist trying something that may save lives?  Under a Dr's supervision this medication has little downside re side effects.  Dr. Fauci recommends prescribing it to severe cases.  I trust him more than some tweet saying "nada."

Oh, and now we are trusting "controlled" studies from China?

Yes, if I were treating an ICU patient with Covid-19, I would probably reach for the chloroquine and I would try to get Gilead to send some Remdesivir, and whatever else might have a reasonable chance to work, at least until enough evidence accumulates to support or discourage its use.

That's not the same thing as saying the drug works, though.  The medical literature is littered with interventions that became the standard of care because everyone believed that they worked until a high-quality randomized controlled trial showed it made no difference.

BC
(03-25-2020, 01:56 PM)BostonCard Wrote: [ -> ]
(03-25-2020, 01:56 PM)M T Wrote: [ -> ]BC, the study NCT04261517 is the one reported on yesterday.  The other study of 150 patients, comparing HCQ versus Lopinavir/ritonavir, is in phase 2.

I'm surprised anyone with any credentials would jump on one small study (which seems flawed to me) and declare "nada" when there was another study of about the same size (and seemed flawed to me too) that seemed to have different results. 
To be clear, I didn't jump on one study as dispositive ...

BC, I apologize for not being clear.  I was NOT referring to you.

I was referring to the tweet by Laurie Garret who declared "nada".
Quote:Here it is: The only controlled trial using #Chloroquine to treat #COVID19 - from China - finds zero benefit compared to placebo. Zip, nada. In other words, @realDonaldTrump --it does NOT work.
I started composing my post when that tweet was in the latest post (none of the miracle cure posts were made at that time).  By the time I finished it, other posts had intervened and the reference to "nada" was not sufficient.  I am going to edit that post to name her.

I agree that a single miracle cure is but a single datum.
No problem.

BC
Clinical trials? When faced with a deadly pandemic, Bones didn't need a clinical trial.

Miri
(03-25-2020, 05:17 PM)cardcrimson Wrote: [ -> ]Clinical trials? When faced with a deadly pandemic, Bones didn't need a clinical trial.
Actually, that would be called an "n-of-1" trial with historical controls. When every one in the (very large) control group has died, one-out-of-one cure reaches statistical significance!  :)  (and excellent Star Trek reference!)
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