74Ag1 said:

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Infection_Ag11 said:

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74Ag1 said:

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When does an unproven drug that works become proven?

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We don't know it works yet, that's the point. Right now all we have are a lot of anecdotal reports both that it works and that it doesn't.

As others have pointed out though, there are quite a few pre-print articles circulating that are awaiting peer review and nearly all are showing no statistical benefit.

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So do you prescribe it if it shows no benefit?
Maybe you should Stop using it if you don't think it works.

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Look I understand your desire for this to work, but as Infection Ag and other physicians on here have pointed out all the data now is anecdotal. I'm a biotech rep and totally understand the value of a study that is statistically significant in proving efficacy. They have to randomize a lot of patients a various stages of the disease and give half active drug and half a placebo. Neither the patient or doctor will know what they are getting, they all will think they are getting the active drug. Only after doing this can they say for sure it works early in patients in reducing hospitalizations or death etc. versus placebo. Or if it helps at all in later stages of disease. or only helps in the early stages but not later stages etc etc. The thing is that placebos are incredibly effective meds for many ailments because of the power of the mind. If you believe it helps or works it often will, this is why so many supplements can claim all sorts of great benefits and have testimonials to back it up. Do they work for real?? Maybe but without a true trial you really don't know. If you hear those commercial on a supplement you always have the disclaimer these statements have not been evaluated by the FDA, meaning there isn't a trial or at least one that could be submitted to the FDA for proof.

It may not save any lives, see my post above or HouAggie one below. We need to study it to find out if it works and where. You say many are getting great results, so can they say its from HCQ or would those patients have improved anyways? That is what we need to find out.

What assumption did I make?

HouAggie2007 said:

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What assumption did I make?

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If I was a dr I would remember the people that died more than the ones that recovered.

"But because we don't have anything else proven they are going to continue to try and hope it works. And the vital importance to confirm that it actually works so we can move to a mitigation or treatment of this virus? I don't know how else to spell it out to you if you don't"

Also how is this slowing down anything moving to mitigation or treatment?

Couple of studies coming out that show no improvement with HCQ (note these are preprints, not final peer reviewed publications)

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To assess the efficacy and safety of hydroxychloroquine (HCQ) plus standard-of-care (SOC) compared with SOC alone in adult patients with COVID-19. Design Multicenter, open-label, randomized controlled trial. Setting 16 government-designated COVID-19 treatment centers in China through 11 to 29 in February 2020. Participants 150 patients hospitalized with COVID-19. 75 patients were assigned to HCQ plus SOC and 75 were assigned to SOC alone (control group). Interventions HCQ was administrated with a loading dose of 1, 200 mg daily for three days followed by a maintained dose of 800 mg daily for the remaining days (total treatment duration: 2 or 3 weeks for mild/moderate or severe patients, respectively). Main outcome measures The primary endpoint was the 28-day negative conversion rate of SARS-CoV-2. The assessed secondary endpoints were negative conversion rate at day 4, 7, 10, 14 or 21, the improvement rate of clinical symptoms within 28-day, normalization of C-reactive protein and blood lymphocyte count within 28-day. Primary and secondary analysis was by intention to treat. Adverse events were assessed in the safety population. Results The overall 28-day negative conversion rate was not different between SOC plus HCQ and SOC group (Kaplan-Meier estimates 85.4% versus 81.3%, P=0.341). Negative conversion rate at day 4, 7, 10, 14 or 21 was also similar between the two groups. No different 28-day symptoms alleviation rate was observed between the two groups. A significant efficacy of HCQ on alleviating symptoms was observed when the confounding effects of anti-viral agents were removed in the post-hoc analysis (Hazard ratio, 8.83, 95%CI, 1.09 to 71.3). This was further supported by a significantly greater reduction of CRP (6.986 in SOC plus HCQ versus 2.723 in SOC, milligram/liter, P=0.045) conferred by the addition of HCQ, which also led to more rapid recovery of lymphopenia, albeit no statistical significance. Adverse events were found in 8.8% of SOC and 30% of HCQ recipients with two serious adverse events. The most common adverse event in the HCQ recipients was diarrhea (10%). Conclusions The administration of HCQ did not result in a higher negative conversion rate but more alleviation of clinical symptoms than SOC alone in patients hospitalized with COVID-19 without receiving antiviral treatment, possibly through anti-inflammatory effects. Adverse events were significantly increased in HCQ recipients but no apparently increase of serious adverse events. Trial registration ChiCTR2000029868.

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https://www.medrxiv.org/content/10.1101/2020.04.10.20060558v1

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Treatments are urgently needed to prevent respiratory failure and deaths from coronavirus disease 2019 (COVID-19). Hydroxychloroquine (HCQ) has received worldwide attention because of positive results from small studies. Methods We used data collected from routine care of all adults in 4 French hospitals with documented SARS-CoV-2 pneumonia and requiring oxygen 2 L/min to emulate a target trial aimed at assessing the effectiveness of HCQ at 600 mg/day. The composite primary endpoint was transfer to intensive care unit (ICU) within 7 days from inclusion and/or death from any cause. Analyses were adjusted for confounding factors by inverse probability of treatment weighting. Results This study included 181 patients with SARS-CoV-2 pneumonia; 84 received HCQ within 48 hours of admission (HCQ group) and 97 did not (no-HCQ group). Initial severity was well balanced between the groups. In the weighted analysis, 20.2% patients in the HCQ group were transferred to the ICU or died within 7 days vs 22.1% in the no-HCQ group (16 vs 21 events, relative risk [RR] 0.91, 95% CI 0.47-1.80). In the HCQ group, 2.8% of the patients died within 7 days vs 4.6% in the no-HCQ group (3 vs 4 events, RR 0.61, 95% CI 0.13-2.89), and 27.4% and 24.1%, respectively, developed acute respiratory distress syndrome within 7 days (24 vs 23 events, RR 1.14, 95% CI 0.65-2.00). Eight patients receiving HCQ (9.5%) experienced electrocardiogram modifications requiring HCQ discontinuation. Interpretation These results do not support the use of HCQ in patients hospitalized for documented SARS-CoV-2-positive hypoxic pneumonia.

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https://www.medrxiv.org/content/10.1101/2020.04.10.20060699v1

However it should be noted that both of these studies seem to be treating hospitalized patients, when as many have discussed here and there is some agreement that HCQ would see the most benefit after initial onset of symptoms.

Not sure your first study stands for the proposition of "no improvement" from HCl treatment when it says:

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A significant efficacy of HCQ on alleviating symptoms was observed when the confounding effects of anti-viral agents were removed in the post-hoc analysis (Hazard ratio, 8.83, 95%CI, 1.09 to 71.3).

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The administration of HCQ did not result in a higher negative conversion rate but more alleviation of clinical symptoms than SOC alone in patients hospitalized with COVID-19 without receiving antiviral treatment, possibly through anti-inflammatory effects

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But I'm willing to listen to an explanation to the contrary.

The next line stated it was not statistically significant

Another --

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This preprint reports a double-blind, randomized clinical trial of 62 patients to assess the efficacy of hydroxychloroquine (HCQ) in mild COVID-19. Patients in the treatment arm received 400 mg HCQ per day for 5 days. Fever and cough resolved on average 1 day earlier with HCQ, although the distribution of symptomatic patients at day 0 was not even between groups. No patients receiving HCQ progressed to severe disease, whereas 4 of 31 patients in the control arm progressed. Few clinical data and no viral load measurements were reported, limiting the conclusions that can be drawn from this trial. This study suggests relative efficacy for patients with mild disease and warrants larger clinical trials, but the effects of HCQ on patients with more severe COVID-19 remain unknown.

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https://www.nature.com/articles/s41577-020-0315-4?utm_source=dlvr.it&utm_medium=twitter

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Aims: Studies have indicated that chloroquine (CQ) shows antagonism against COVID-19 in vitro. However, evidence regarding its effects in patients is limited. This study aims to evaluate the efficacy of hydroxychloroquine (HCQ) in the treatment of patients with COVID-19. Main methods: From February 4 to February 28, 2020, 62 patients suffering from COVID-19 were diagnosed and admitted to Renmin Hospital of Wuhan University. All participants were randomized in a parallel-group trial, 31 patients were assigned to receive an additional 5-day HCQ (400 mg/d) treatment, Time to clinical recovery (TTCR), clinical characteristics, and radiological results were assessed at baseline and 5 days after treatment to evaluate the effect of HCQ. Key findings: For the 62 COVID-19 patients, 46.8% (29 of 62) were male and 53.2% (33 of 62) were female, the mean age was 44.7 (15.3) years. No difference in the age and sex distribution between the control group and the HCQ group. But for TTCR, the body temperature recovery time and the cough remission time were significantly shortened in the HCQ treatment group. Besides, a larger proportion of patients with improved pneumonia in the HCQ treatment group (80.6%, 25 of 31) compared with the control group (54.8%, 17 of 31). Notably, all 4 patients progressed to severe illness that occurred in the control group. However, there were 2 patients with mild adverse reactions in the HCQ treatment group. Significance: Among patients with COVID-19, the use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia.

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

Ranger222 said:

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The next line stated it was not statistically significant

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I'm assuming you're referring to this section, and if you are, I'm fairly certain you're misreading it. I've bolded some key parts for you.

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A significant efficacy of HCQ on alleviating symptoms was observed when the confounding effects of anti-viral agents were removed in the post-hoc analysis (Hazard ratio, 8.83, 95%CI, 1.09 to 71.3). This was further supported by a significantly greater reduction of CRP (6.986 in SOC plus HCQ versus 2.723 in SOC, milligram/liter, P=0.045) conferred by the addition of HCQ, which also led to more rapid recovery of lymphopenia, albeit no statistical significance.

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Everything including the first bolded section up to the second is "significant," according to the study. Only the second bolded section, referencing a more rapid recovery of lymphophenia, has no statistical significance.

https://heroesresearch.org/hero-hcq/

Question about the combo of HCQ-Azithro potentially causing longer QT intervals / arythmias.... is it the combo together or simply the Azithro causing it? Seems I've heard people saying it's the Azithro that is more of a cause. But I've taken Z-Packs in the past with absolutely no issues and the doctor has never even brought that up. Is it not an issue unless taken along with HCQ?

Marcus Aurelius said:

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https://www.al.com/news/2020/04/uab-doctor-who-got-coronavirus-unhappy-he-tried-unproven-treatment.html

Prominent UAB ID doc contracted COVID-19 and took HCQ/Azithromycin initially. Now "regrets it." It's one thing to stare down at these unproven potential therapies from the "well Ivory Tower" as it were. But looking at the double barrel shotgun right now? Give me HCQ/Azithromycin symptom day one. Remdisivir if I get admitted and need supplemental O2. Tociluzimab if I develop cytokine storm. Full disclosure - I have hypertension so at more risk.

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I assume you would stop HCQ+A if it wasn't working and switch to Remdisivir . Right?

https://www.galvnews.com/news/free/article_c9e87c36-f471-5b1a-a5c2-4016a5eac1dc.html

Had not seen this posted.

valtosca said:

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https://www.galvnews.com/news/free/article_c9e87c36-f471-5b1a-a5c2-4016a5eac1dc.html

Had not seen this posted.

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member of the Galveston Pachyderm Club

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Well that's random.

valtosca said:

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https://www.galvnews.com/news/free/article_c9e87c36-f471-5b1a-a5c2-4016a5eac1dc.html

Had not seen this posted.

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Interesting anecdotes....

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On Sunday, 39 COVID-19-infected patients under Armstrong's care at The Resort at Texas City nursing home completed a five-day regimen of hydroxychloroquine, a drug approved by the FDA for treatment of rheumatoid arthritis, malaria and lupus, but not the coronavirus.
"After Sunday, none of them will be on it anymore," Armstrong said. "We're just happy the patients are better."
Armstrong based that observation on how the 39 nursing home residents appear, on no evidence of increased shortness of breath and that no one started on it had been hospitalized, he said.

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The Galveston County Health District announced April 3 that 83 employees and residents of The Resort at Texas City, 1720 N. Logan St., had tested positive for COVID-19.
Two days later, Armstrong began treating 27 residents with hydroxychloroquine, made available to him with the help of Lt Gov. Dan Patrick, he said.
Twelve additional patients were added to the five-day treatment regimen hydroxychloroquine with azithromycin or Z-Pac and a zinc supplement over the next few days.
All patients completed the five-day treatment on Sunday. Armstrong and his team will continue to monitor them all were symptomatic for COVID-19 before receiving the medication and will share what they observe, he said.

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It will be interesting if none of the nursing home residents are hospitalized. However, it may be too soon to tell.

Interesting. I'm glad they're doing well so far and hope they continue to do well.

I'd love to get more details about the health of the residents and use of the drug at the home, unwound and away from all the other stuff in that article.

Player To Be Named Later said:

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It would be nice if we could see a study done where all of the subjects given HCQ were given the drug very shortly after experiencing symptoms.

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Several large studies have kicked off; we'll have a ton more data by mid-late summer (well after the first wave is over):

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The FDA has approved chloroquine as a COVID-19 treatment. Did it do so despite a "lack of scientific evidence?" In fact, there is abundant evidence from many international sources supporting the efficacy of chloroquine in various forms and in combination with several other drugs. To take just one example among many, a survey of more than 6,000 international physicians found that Hydroxychloroquine was the treatment deemed effective by the largest number, 37%.

...but what is actually happening is interesting. Governor Noem has been working closely with President Trump and Vice President Pence to set up the largest clinical trial of Hydroxychloroquine that, to my knowledge, has so far taken place. South Dakota has secured access to a large number of doses of Hydroxychloroquine from the national stockpile to conduct a series of tests, in conjunction with some of the Midwest's major hospital groups.

There will be two tracks: one will test Hydroxychloroquine among those who have tested positive for COVID-19 and have been hospitalized. The second will be prophylactic, testing the drug among high-risk populations that have not been hospitalized, like health care workers. This will be a double-blind study that begins with a clinical trial involving 2,000 patients, but could be expanded to as many as 100,000. This study will tell us more about the effectiveness of Hydroxychloroquine than any other study has done, to my knowledge, to date.

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A large clinical trial is kicking off studying the efficacy of hydroxychloroquine for prophylaxis. They are looking for 15,000 healthcare workers across the country. They have also developed a registry for healthcare workers as they are going to be doing continuous research.

https://today.duke.edu/2020/04/health-care-workers-encouraged-join-covid-19-clinical-trial-registry

Can someone give me a refresher on how this particular drug became a candidate for covid-19 treatment?

I mean was it some country just trying random **** and fell on this? Was it a statistically impossibly low number of current users getting sick? Was there some previous research on using this drug for other viral infections?

I get how it is supposed to work but my question is why was it tried?

Duncan Idaho said:

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Can someone give me a refresher on how this particular drug became a candidate for covid-19 treatment?

I mean was it some country just trying random **** and fell on this? Was it a statistically impossibly low number of current users getting sick? Was there some previous research on using this drug for other viral infections?

I get how it is supposed to work but my question is why was it tried?

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A number of studies were done prior to covid-19 on the efficacy of HCQ on coronavirus and in particular the SARS and MERS versions of coronavirus.

https://scholar.google.com/scholar?q=coronavirus+hydroxychloroquine&hl=en&as_sdt=0%2C44&as_ylo=2003&as_yhi=2018

Thanks.