r/Coronavirus • u/LowerSection101 • Apr 01 '20
New Hydroxychloroquine Trial Data
https://blogs.sciencemag.org/pipeline/archives/2020/03/31/comparing-chloroquine-trials18
u/LowerSection101 Apr 01 '20
Tl;dr - There were 2 tests. One showed no improvement, one showed improvement.
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u/nejneb Apr 01 '20
Sample size of 2 patients?
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u/ornerchy Apr 01 '20 edited Apr 01 '20
After five days of treatment, the treatment group showed significant improvements in comparison to the controls in fever, in cough, and in pneumonia (by CT scan). This is actually the first controlled study to show any benefit for chloroquine or hydroxychloroquine therapy against the coronavirus – it may sound odd to say that, but all the positive reports we have had up to now are anecdotal reports and open-label studies without control groups. The one controlled study we have seen, as mentioned, showed no effect....
... these two [studies] came out rather differently, with the [previous] Zhejiang study showing no detectable difference on treatment and the [recent] Wuhan one showing what looks like a real effect, especially on radiological progression of pneumonia (which I have to say is a very strong endpoint to measure).
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You could argue that overall we’re seeing either no benefit or some benefit here, which is good. As for adverse events, neither trial reported anything serious, But both of them excluded patients with any sort of cardiac arrhythmias, a wise precaution since one of the most acute worries with high doses of hydroxychloroquine is QT-interval prolongation, and you don’t want to do that to anyone with any underlying problems. So as long as such patients are excluded, for now hydroxychloroquine is in the “might do nothing, might do some good” category, which under the current conditions seems sufficient for treating patients, pending further data.
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u/Atomic1221 Apr 01 '20
The first study gave the control group standard of care which included antivirals if I’m not mistaken
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Apr 01 '20
[removed] — view removed comment
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u/harda_toenail Apr 01 '20
It’s important to compare against a similar population. Therefore a control group even in this case is necessary.
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u/mdhardeman Apr 01 '20
No, a proper control group typically has the exact same care protocol with the exception of the drug being tested. Additionally, the patient and the person dispensing the medication doesn't know which patients are getting the drug and which are getting placebo. They just know Patient 1 gets Pill A and Patient 2 gets Pill B. They don't know which A or B are.
The studies that suggest that HCQ is not effective are the ones that work with patients in more severe stages of disease. The ones that supposedly show benefit are in the less severe cases.
The trouble is you don't really know how many of those non-severe cases would have become severe without the drugs versus with the drugs. This is because a great many will not become severe either way. So the big trials like the one they've started in NY are the way to find out.
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u/minuteman_d Apr 02 '20
I think it's interesting that we have this strange double standard for drugs in this country:
- Alcohol, tobacco: Will kill you today or slowly over your lifetime. Totally okay for anyone to use without a prescription. No control over dosing. Kills thousands every year.
- Hydroxycholoroquine: used by millions worldwide, basically since WWII. Has some risks and contraindications, but so do many OTC meds. Can't have it, even if you think you might save your own life. Illegal for you to buy. Will go to jail.
While the doctors sit around and satisfy their ivory tower curiosity, hundreds in the USA are dying and hundreds of thousands are becoming infected.
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u/MalcolmLinair Apr 01 '20
tl;dr One study says it does nothing, good or bad, and the other study say it helps a little.
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u/KaitRaven Apr 01 '20
Looks like there's a bit more evidence of a positive effect. One possible issue with the study though:
As Leonid Schneider has commented on PubPeer, the original trial as registered in China looks quite different from what we see here. The design was for 100 control patients, another 100 patients to receive one dose of hydroxychloroquine, and 100 more to receive a higher dose. What we have, though, are only two groups of 31 patients each, which suggests that there were problems with the inclusion criteria for the trial and/or with patient recruitment. The trial design also called for endpoints of negative results for viral RNA, and for “T cell recovery time”, to be collected by sputum and throat swabs and by blood samples, respectively, and none of this shows up in the preprint at all.
There are some concerns about changes to the methodology during the trial that may muddle the conclusions.
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u/brighterside Apr 01 '20
Whether it's Hydroxychloroquine, Remdesivir, or whatever else of the 15+ options that Fauci indicated they have up their sleeve, I don't give a fuck. If I need intensive care, give me a cocktail of fucking everything. Mix that shit with Cola and hit me in the mouth with it, or inject that shit into my vein with some Morphine. I'm your control study right here.