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Author Topic: Health Professionals and COVID-19  (Read 1055 times)
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o_e_l_e_o (OP)
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April 06, 2020, 09:54:45 AM
 #41

The trials with which I am involved all have their own exclusion criteria. Pregnancy is an exclusion for them all. Very severe comorbidities, especially heart disease, is usually a contraindication, but as these patients are not being admitted to intensive care anyway, we have not (to my knowledge) excluded anyone at our center for that reason. Patients or next of kin can choose to opt out of being included in a trial if they wish.

As I am working largely in the emergency department and intensive care, I can't speak for trials in less severe cases.
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April 06, 2020, 10:01:34 AM
Merited by o_e_l_e_o (2)
 #42

are they including patients in the 'atrisk' group like pregnant, heart issues, diabetic.
....

you can search by yourself https://clinicaltrials.gov/

I made for you a selection HQC:
https://clinicaltrials.gov/ct2/results?term=hydroxychloroquine&recrs=adfm&type=Intr&cond=%22Respiratory+Tract+Infections%22&phase=12
[hydroxychloroquine | Recruiting, Active, not recruiting, Enrolling by invitation, Unknown status Studies | Interventional Studies | "Respiratory Tract Infections" | Phase 2, 3]

https://clinicaltrials.gov/ct2/results?term=hydroxychloroquine&recrs=adfm&type=Intr&cond=%22Severe+Acute+Respiratory+Syndrome%22&phase=12
[hydroxychloroquine | Recruiting, Active, not recruiting, Enrolling by invitation, Unknown status Studies | Interventional Studies | "Severe Acute Respiratory Syndrome" | Phase 2, 3]

https://clinicaltrials.gov/ct2/results?term=hydroxychloroquine&recrs=adfm&type=Intr&cond=%22Coronavirus+Infections%22&phase=12
[hydroxychloroquine | Recruiting, Active, not recruiting, Enrolling by invitation, Unknown status Studies | Interventional Studies | "Coronavirus Infections" | Phase 2, 3]

Check exclusion criteria of each trial listed,  related hearth issues (?), normally protocol specify very well what are these "heart issues", or you find a generic phrase like:
"Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial"
Find below some exclusions  examples (taken from links):
 
Patients with long QT syndrome or severe ventricular arrhythmias;
Patients using drugs that prolong the QT interval;
Patients with retinopathy or macular degeneration; (these can be diabetics but I haven't find a specific exclusion for diabetic patients).
Use of medications that are contraindicated with hydroxychloroquine: citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine;

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April 06, 2020, 10:43:46 AM
Last edit: April 06, 2020, 12:29:50 PM by franky1
 #43

i didnt mean the people with heart disease symptoms being the cause of their hospitalisation. i meant the ones in there for corona symptoms but just happen to have other issues previously

also i was thinking more about the relaxed policies some hospitals have been given that doctors can administer it as not an official trial but just another tool in a doctors toolbox for those they feel need it. an unofficial 'trial' to cover them legally to try it
which many countries have as the legal loophole

im guessing by your answers your hospital is just sticking to treatment for only official trial enrolled patients..

EDIT
to answer below.. to save spamming this topic
im not getting into a grammar nazi/dick measuring contest to disrupt the topic
i was asking o e le o a question. so no point talking to someone else who just jumps into the question

im not interested in getting into the legality of the buzzwording of usage outside of an official trial.
thats why in the first post i just said 'trial' with semi quotes around.
i was trying to be subtle
im not interested in the legal buzzwording conversation.

my point was just because there is news that patients who are not official trial enrolled are getting it..
call it therapeutic, compassionate, hailmary, last ditch (not the point in grammar naziing the buzzword that makes it allowed)


but as i said. it seems o e l e o's hospital seems to be just using it only on trial enrolled patients. thus the scope of pro-con use for patient with other issues wont really be studied as much if they are not getting it.. thus i accept o e l e o wont have experience of it.

next edit:
seems he really wants to get into a grammar dick measuring exercise (facepalm)
the actual ettiquite for asking a question to someone is not an @ sign.. thats never been a thing on this forum
instead quoting someone and then asking them a question. makes it relevant to the person in the quote

and if you did not realise it. but in places like spain its shown on polls that 70% of doctors has given it to patients.
yet we dont see thousands of official trials.. simple maths.. basic logic conclusion. its given outside of official trials

anyway o e l e o gave me a satisfactory answer.. so just end your grammar nazi drama



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April 06, 2020, 10:50:59 AM
Last edit: April 06, 2020, 12:12:24 PM by bitbollo
 #44

i didnt mean the people with heart disease symptoms being the cause of their hospitalisation. i meant the ones in there for corona symptoms but just happen to have other issues previously
...
Dear @franky1 yes It was clear that you were not talking about "heart disease symptoms being the cause of their hospitalisation" but related pre-exiting condition.
Check my previous post, there are few examples.

...
 unofficial 'trial'
...

I don't know what you mean by 'unofficial trial' (maybe are you referring to compassionate use? or off label ? really I have no idea ...) since according GCP/ICH/ any law of any Country, no one will never run an "unofficial trial".

Otherwise something like this will no have any value (nor legally not scientific)... Plus if some one will run something like this can risk a lot of legal implications, fine, license trashed...


EDIT:
Dear @franky1 replying to your edit above, next time use @username when you made a question to some one, since anyone could reply/answer to a question.

Legality of "trial" is the basic of a trial!  
If you don't know what we are talking about, try to check what is an IRB/IEC or read GCP:  this is literally the basic of any trial.


Quote
"patients who are not official trial enrolled are getting it."

EH?

Quote
of pro-con use for patient with other issues wont really be studied as much if they are not getting it..

I posted a search that I made for you, thanks for ignore it.
As I have already explained if these patients are not EXCLUDED by a protocol/medical judgement they can be included in any trial.

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