Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949
First of all, there are a substantial amount of limitations to the study but in my opinion, not medical advice, it provides a glimmer of hope.
Let's begin
Where was it performed: French study (thank youuuuuu!)
Population: NOT ICU Patients! But we've learned that non-ICU patients become ICU patients extremely quick!
n=36 (20 hydroxychloroquine, 16 control)
How did the determine the Viral load? Nasopharyngeal swabs daily
Questions I have: 6 patients (originally n=42) lost to follow up. Patients who were transferred to the ICU were considered to be "lost to follow-up" (n=3). I can't tell if the one patient who died was transferred to the ICU. Hopefully the edits will sort this out. Why didn't they just follow those patients who ended up in the ICU?
Age groups were not matched but this would favor the control group as the experimental group was older. More were male in the experimental group which we assume that males get this worse than females. More asymptomatic patients in the control group, also bodes worse for the experimental arm.
Questions I have: 6 patients (originally n=42) lost to follow up. Patients who were transferred to the ICU were considered to be "lost to follow-up" (n=3). I can't tell if the one patient who died was transferred to the ICU. Hopefully the edits will sort this out. Why didn't they just follow those patients who ended up in the ICU?
Age groups were not matched but this would favor the control group as the experimental group was older. More were male in the experimental group which we assume that males get this worse than females. More asymptomatic patients in the control group, also bodes worse for the experimental arm.
3 classifications: asymptomatic, upper respiratory, lower respiratory
Regimen:
Hydroxychloroquine 600mg daily (200mg TID x 10 days)
+/- azithromycin depending on clinical presentation (500mg on day 1, 250mg x 4 days)
Results:
At day 6, 70% of hydroxychloroquine group were virologically cured vs. 12.5% in control group (p=0.001) NNT = 1.7!!
100% of hydroxychloroquine + azithromycin were virologically cured vs 57.1% in the hydroxychloroquine only group vs. 12.5% in the control group (p0.001)
Drug effect was higher in URI and LRI than asymptomatic patients (p=0.05)
Starts working in 3-6 days per this data.
Careful with the QT prolongation on the EKG! Replete the Mg as needed for this. Monitor liver function. My pharmacy friends can contribute some more adverse effect stuff like retinopathy, etc.
I cannot make any recommendations as I do not give medical advice but I know what I would do with this data to save a life.
-EJ
An Update on 3/29/2020
We have an update now from the same researchers in France. It's a free PDF and I recommend you read it yourself. Don't trust me.
Interesting that the authors mention potentially using ARBs, metformin, and statins as many have directly messaged me asking what I thought on these particular families of treatments. This study has me scratching my head. Their first study seemed like they rushed it out the door to start some more broad research. This study seems like they're deliberately hiding things from us or trying to remain obscure.
Methods:This is an observational study, meaning they didn't have any controls.
80% of patients appear to have gotten a CT of the chest and (almost) every patient had a daily nasopharyngeal swab.
They all got an EKG before treatment and two days after treatment began. They had criteria to not start therapy based on some findings listed in the article.
Treatment regimen:Hydroxychloroquine 200mg three time a day for 10 days
Azithromycin 500mg on day 1, then 250 daily for 4 days
End points (these are not your typical endpoints):
They all got an EKG before treatment and two days after treatment began. They had criteria to not start therapy based on some findings listed in the article.
Treatment regimen:Hydroxychloroquine 200mg three time a day for 10 days
Azithromycin 500mg on day 1, then 250 daily for 4 days
End points (these are not your typical endpoints):
Clinical Outcome (oxygen therapy or ICU transfer)
Contagiousness by PCR and culture
Length of stay in the ID ward
Things to know:n=80
4 patients were asymptomatic carriers (then why were they in the COVID unit?)
92% of the patients were less ill based on their made up NEWS score
52.8% had lower respiratory infections/pneumonia.
Results:
We don't have any controls to know if this is the normal course of the infection or if the hydroxychloroquine actually worked or not. I forgive them for not having controls in the prior study but this is now too much.
93.8% were discharged from a low NEWS score. Don't forget that 92% had a low news score to begin with!
3 patients still ended up in the ICU.
The nasopharyngeal viral load fell. Sure. Cool. Thanks. But does this normally fall at this rate without treatment? We need controls. Is the decrease in contagiousness the normal evolution or the drugs working? We don't know. No controls.
I'm tired of reviewing this study. You all get my point. I am in favor of trying it, but I feel like there's some academic dishonesty happening here.
I really want this to work. I really really do. We need some good news but we also need to solidify our management with better data.
Link to full FREE PDF
Although great care has been taken to ensure that the information in this post is accurate, eddyjoemd, LLC shall not be held responsible or in any way liable for the continued accuracy of the information, or for any errors, omissions or inaccuracies, or for any consequences arising therefrom.
Contagiousness by PCR and culture
Length of stay in the ID ward
Things to know:n=80
4 patients were asymptomatic carriers (then why were they in the COVID unit?)
92% of the patients were less ill based on their made up NEWS score
52.8% had lower respiratory infections/pneumonia.
Results:
We don't have any controls to know if this is the normal course of the infection or if the hydroxychloroquine actually worked or not. I forgive them for not having controls in the prior study but this is now too much.
93.8% were discharged from a low NEWS score. Don't forget that 92% had a low news score to begin with!
3 patients still ended up in the ICU.
The nasopharyngeal viral load fell. Sure. Cool. Thanks. But does this normally fall at this rate without treatment? We need controls. Is the decrease in contagiousness the normal evolution or the drugs working? We don't know. No controls.
I'm tired of reviewing this study. You all get my point. I am in favor of trying it, but I feel like there's some academic dishonesty happening here.
I really want this to work. I really really do. We need some good news but we also need to solidify our management with better data.
Link to full FREE PDF
Although great care has been taken to ensure that the information in this post is accurate, eddyjoemd, LLC shall not be held responsible or in any way liable for the continued accuracy of the information, or for any errors, omissions or inaccuracies, or for any consequences arising therefrom.
