Posted on 04/24/2020 1:14:42 PM PDT by ProtectOurFreedom
A Randomized Clinical Trial
Findings In this phase IIb randomized clinical trial of 81 patients with COVID-19, an unplanned interim analysis recommended by an independent data safety and monitoring board found that a higher dosage of chloroquine diphosphate for 10 days was associated with more toxic effects and lethality, particularly affecting QTc interval prolongation. The limited sample size did not allow the study to show any benefit overall regarding treatment efficacy.
Meaning The preliminary findings from the CloroCovid-19 trial suggest that higher dosage of chloroquine should not be recommended for the treatment of severe COVID-19, especially among patients also receiving azithromycin and oseltamivir, because of safety concerns regarding QTc interval prolongation and increased lethality.
Main Outcomes and Measures Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4.
(Excerpt) Read more at jamanetwork.com ...
Design, Setting, and Participants This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon.
Interventions Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days).
Results Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to high-dosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%).
Conclusions and Relevance The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir. These findings cannot be extrapolated to patients with nonsevere COVID-19.
Thanks for pointing out/posting the absurdity of this JAMA CQ study.
They didn’t even use the recommended protocol - as suggested by Dr Z and others.
They did NOT use HCQ or Zinc.
So, out the window their silly study goes.
If its good enough for my goldfish....
bump
When will someone scream it to the heavens - it is NOT the HCQ causing cardiac incidents. It is the Z-PAK which has always been known to cause QT problems. it is NOT hcq, it is the ZPAK - and many doctors with cardiac COVID patients simply substitute doxycycline, which has ALWAYS been comparable to ZPAK.
Sorry about the caps - I was fighting the urge to caplock ongoing.
$$$ quote from the article: “...reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group”
and they are testing THE WRONG DRUG!!!!
I know...that’s what I said.
They used CQ, not HCQ.
HYDROXYcloroquine,
HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY, HYDROXY
Paul Sperry
@paulsperry_
If chloroquine’s so “dangerous” & even “poisonous,” why has the CDC for years been advising this:”Both adults and children should take one dose of chloroquine per week starting at least 1 week before traveling to the area where malaria transmission occurs”
https://www.cdc.gov/malaria/resources/pdf/fsp/drugs/chloroquine.pdf
That is a nice color brochure with some interesting details.
Sorry, meant to post to 1
The AMA has long been a leftist organization with a political agenda. In this case, they have committed scientific and medical malpractice by not being honest about HCQ. If the damn stuff is so bad, which lupus or malaria patients will they notify to take them off their medication?
And, per Dr Z....
ZINC, ZINC, ZINC, ZINC, ZINC. ZINC, ZINC, ZINC, ZINC, ZINC, ZINC....
You probably have no idea that choloquine diphosphate and hydroxychloroquine are very different drusg with very different side effect profiles. You are the enemy of the good. Sadly, you are too spiritually dead to see the blood accumulating on your hands.
BTW, agitprop, where is the zinc side of the efficacy scale?
Science has been politicized.
Ultimately that actually may kill us.
“It is the Z-PAK which has always been known to cause QT problems. it is NOT hcq, it is the ZPAK - and many doctors with cardiac COVID patients simply substitute doxycycline, which has ALWAYS been comparable to ZPAK.”
Very interesting. I had HORRIBLE bronchitis the first quarter of 2019. Went through three different antibiotics including a Z-Pak and doxycycline (different times) plus steroids and an inhaler. Took full 12 weeks to get rid of it. I was unaware of possible cardiac complications with azithromycin.
I don’t see in the results where they actually tested a combination of CQ and azithromycin, just CQ... and once again not Hydroxychloriquine. Another bogus test.
What the HELL are you talking about??? I posted this to show the FLAWS in the study that the FDA is using TODAY to denigrate the HCQ / Az / Zinc protocol. Didn’t you read ANYTHING I wrote?
Every other reader understood what I was saying.
Sheesh.
“Main Outcomes and Measures Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group”
I think what this means is that a reduction of 50% in lethality would have been support for using high dose chloroquine.
That is not what happened, however. 39% of the high dose group died, 15% of the low dose group. The high dose group was older. They all had severe disease and the drug was chloroquine not hydroxychloroquine.
Yes.
PLUS, they used Tamiflu in conjunction with CQ and azithromycin, but no Zinc.
Perhaps others have tested antivirals in conjunction with HCQ / CQ and azithromycin, but that’s the first I’ve heard of it.
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