Topic: Health Professionals and COVID-19 (Read 1125 times)

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.


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.



EH?


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.

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

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;

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.

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

i only ask because i have relatives with heart/diabetic issues and if(small if) they did get severe symptoms of respiratory distress from corona and need treatment where these 'trials' are used more fluidly. would doctors be sensible to decline them out of these 'trials' and give other treatments instead. or is it just random selection

Where I am working, almost all patients are being randomized in to a trial. One arm of said trials includes hydroxychloroquine therapy. So there isn't really a medical decision to be made regarding treatment - if they are in the treatment arm they receive it, if they are in any of the other arms, they don't.

Yes, there are anecdotal reports, but there also anecdotal reports of it making no difference, and it carries a number of not-insignificant side effects, including affecting cardiac repolarization and glycemic control.

About hydroxychloroquine (HCQ) there is a big HYPE...
Ruling out France, where there is a medical doctor that made the first paper (find below a short analysis) https://bitcointalksearch.org/topic/m.54066125
and announcement in twitter
https://twitter.com/AceClearance/status/1244243333322506240
with AWESOME RESULTS (no twitter is not a peer reviewed scientific journal and peers evaluate papers not conclusions   ) rest of Europe, with EMA authority (European Medicine Agency) has taken a clear position:
https://www.ema.europa.eu/en/news/covid-19-chloroquine-hydroxychloroquine-only-be-used-clinical-trials-emergency-use-programmes

Fun Fact,
as I have highlighted to some USA member   ... most of people continue to speak about HQC thanks to a "presidential support".
https://www.fiercepharma.com/pharma/europe-locks-down-chloroquine-scripts-as-researchers-china-report-positive-controlled-covid

https://www.latimes.com/business/story/2020-04-01/trump-chloroquine-coronavirus-bad-science-hiltzik-column

That's what the animal test subjects dropped from in startling numbers before they gave up on the last coronavirus vaccine was attempted 10 years ago.  Just FWIW.  But since this post posses some questions about vaccines it will be deleted on this 'self-moderated' thread.

I was not sure what cytokine storm was, so I did a quick google search, and I found this short article.

https://www.newscientist.com/term/cytokine-storm/

Of course, there were plenty of other articles, but this one at least gave a quick overview of the concept.

thank you for explaining, but a  proportion of patients die from "cytokine storm ", sometimes brutally in the street.
so you have to precise the indications.

studies show its effectiveness as a antiviral is not much/any. hense also needing an antiviral as part of treatment. but it has shown some effectiveness at dampening the immuni inflamatory response that causes the breathing distress.

there is not single magic pill and even if able to breathe easier doesnt mean your cured of the actual viral invasion. your just symptomless.
taking these drugs as immuno suppressers when not having an immuno reaction can actually harm you and when you get corona you may end up being worse than you would of if you didnt take it prior to getting corona.

thats why there is stil questions around if its a good enough drug for a certain job and when is best to administer it. as administering it even during ARDS (respiratory distress) can exacerbate the other symptoms

I am not sure what type of practice you have, however if you were treating a patient with COVID-19, can you explain the reasons why you would prescribe someone Hydroxychloroquine to treat the disease? and also can you explain some of the reasons why you would not prescribe Hydroxychloroquine?

This drug has not been proven in effectiveness in treating COVID-19, however clinical trials required to show proof can take time that hundreds of thousands of people may not have, and there is some anecdotal evidence that it works. 

You are immune when you produce specific antibodies for the disease.
Not every disease grant immunity forever, but it's reasonable that the few observed remission cases are an exception.

Very interesting @erre.
Could you please clarify what "immune" means?
I heard, I might be wrong here, that second infections were observed in recovered patients. "Immune" makes me think that second infections aren't even possible.

IMPORTANT NOTICE: the above time values are MEDIANS, not the upper limited of a confidence interval.

Considering that an asymptomatic is no more contagious after 2 weeks because that's the median value is very imprudent (50% will be still contagious if the distribution is gaussian).

This common error is killing people in italy.

An interesting list of vaccine projects has been posted on Evaluate Pharma, please find below these updates:

Latest clinical trials results posted today March 24th 2020, please find below a short summary with references.

According to this small study, as reported on Fiercepharma hydroxychloroquine has provided disappointing results vs conventional treatment.

As claimed by the same news on Fiercepharma there is also another trial fail published today in this preprint paper , where subjects have been randomized to lopinavir/ritonavir (Kaletra® also known as Aluvia®) or Umifenovir (Arbidol®) or no antiviral medication as control (2:2:1)


(LAST and FINAL EDIT/UPDATE March 27th at 09:34)

I cannot share other informations and I can't update this post anymore because even my company will work in a clinical trial related COVID19 (public announcement not done)
Thanks to all and STAY SAFE!

Latest updates from FiercePharma and Evaluate about new treatments for COVID-19 infection.
Please find below a short summary and various references.
I will keep posting information about new treatments only on this post (LAST and FINAL EDIT/UPDATE March 27th at 09:34)

I cannot share other informations and I can't update this post anymore because even my company will work in a clinical trial related COVID19 (public announcement not done)
Thanks to all and STAY SAFE!

KALETRA® (ALUVIA®) - Lopinavir/Ritonavir - Abbvie
AbbVie will not enforce global patent rights on all formulations of HIV med Kaletra (Aluvia) as the drug is being evaluated to treat severe COVID-19 in several clinical trials.
The move would free countries to purchase Kaletra generics in the event of a shortage or if the drug is found to be effective in treating COVID-19 patients. ¹

Remdesivir - Gilead
Gilead Sciences temporarily stopped granting patients emergency access to remdesivir under compassionate use due to an “exponential increase” in requests over the last few days, the company said Sunday. Exceptions will be made for pregnant women and children under 18 with severe COVID-19, the disease caused by the novel coronavirus.²

ACTMERA® - Tocilizumab - Genetech (Roche subsidiary)
FDA has approved a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.³

INOpulse®  - Nitric oxide (iNO) delivery system - Bellerophon
FDA Grants Bellerophon Emergency Expanded Access for INOpulse® for the Treatment of COVID-19 Virus. ⁴

Blood Plasma-Derived Antibodies - Takeda
Takeda Pharmaceutical Co. said its blood plasma-derived therapy against coronavirus currently in development has the potential to be among the first approved treatments for the deadly pathogen.⁵

Chloroquine Phosphate Hydroxychloroquine Sulphate - Ipca Laboratories
The FDA has lifted an import alert on India's Ipca Laboratories, one of makers of chloroquine (Active Product Ingredient) of this anti-malaria drug that could hold promise in managing and treating COVID-19 ⁶

Avigan® Favilavir® - Favipiravir - Fujifilm's
Chinese Clinical trial data demonstrated reduced viral load and improved X-Rays in treated patients.
However Japanese Officials note that it need to be used early, since the drug not appear to be as effective in people with severe symptoms. According to the same reference, it could be approved as early as May ⁷

Sylvant® - Siltuximab - Eusa Pharma
They are running an observational study on compassionate use in patients with serious complications of COVID-19 and the opportunity to generate data to understand the potential for IL-6 blockade in these patients. ⁸

Nafamostat Mesylate [generic drug] - Futhan® -  Nichi-iko Pharmaceutical Co. (producer)
A blood thinner used to treat pancreatitis and kidney disease has been identified as a potential therapy for COVID-19 patients. Clinical trials in Japan possibly set to begin in March 2020 ⁹

PUL-042 - Pulmotect  [new treatment added on this list March 24th 03:53 PM]
This is a prevention study that has lead positive data in preclinical stage. Phase I has been completed. Phase II to be initiated this year according the statement on reference¹⁰

SNG001 - Synairgen [new treatment added on this list March 25th 20:40 PM]
This company will start a Phase II trial (double blind and placebo controlled) in COVID-19 patients according to their statement "imminently"
¹¹

INOmax® - Nitric oxide (iNO) Mallinckrodt [new treatment added on this list March 25th 20:40PM]
They will start to evaluate the evidence of efficacy about their iNO delivery system for pulmonary complications associated with coronavirus.
(first announcement made on March 12th 2020)
¹²

remestemcel-L - Mesoblast [new treatment added on this list March 25th 20:40 PM]
Plans to evaluate its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) ¹³
(first announcement made on March 10th 2020)

(LAST and FINAL EDIT/UPDATE March 27th at 09:33)
I cannot share other informations and I can't update this post anymore because even my company will work in a clinical trial related COVID19 (public announcement not done)
Thanks to all and STAY SAFE!

[There is actually no treatment approved for COVID-19. I am not involved in any of these companies.
Visit FiercePharma or visit Evaluatefor further information and updates on COVID-19.]
[Legend= Brand Name® - API (Active Pharmaceutical Ingredient) - Company Name]

¹ https://www.ft.com/content/5a7a9658-6d1f-11ea-89df-41bea055720b
² https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-access-to-remdesivir-outside-of-clinical-trials
³ https://www.businesswire.com/news/home/20200323005166/en/Genentech-Announces-FDA-Approval-Clinical-Trial-Actemra
⁴http://investors.bellerophon.com/news-releases/news-release-details/fda-grants-bellerophon-emergency-expanded-access-inopulser
⁵ https://www.bnnbloomberg.ca/drugmaker-takeda-sees-speedy-approval-of-coronavirus-treatment-1.1407334
⁶ https://www.bseindia.com/xml-data/corpfiling/AttachLive/af31e003-575e-4550-b6f2-c1340aec82e9.pdf
⁷ https://pbs.twimg.com/media/ETadjJVWoAAXv-4?format=jpg&name=4096x4096
⁸ https://www.biospace.com/article/releases/eusa-pharma-and-the-papa-giovanni-xxiii-hospital-bergamo-italy-announce-initiation-of-an-observational-case-control-study-of-siltuximab-in-patients-with-covid-19-who-have-developed-serious-respiratory-complications/
⁹ https://www.bnnbloomberg.ca/japanese-researchers-to-test-blood-thinner-for-virus-treatment-1.1407980
¹⁰ https://pulmotect.com/wp-content/uploads/2020/01/20201_Coronavirus_PR_Final.pdf
¹¹ https://www.synairgen.com/wp-content/uploads/2020/03/200318-Synairgen-to-start-trial-of-SNG001-in-COVID-19-imminently-.pdf
¹² https://mallinckrodt.gcs-web.com/node/26576/pdf
¹³ http://investorsmedia.mesoblast.com/static-files/c1428818-0b9f-44f9-bb4f-79ad518002cc

Your thread your rules. I have reposted the information on potential immune boosting supplements here:

https://bitcointalksearch.org/topic/m.54083990

I do disagree that this is off topic. We are just at the start of this and already there is a nationwide shortages of protective gear.

Coronavirus: Pleas go out for healthcare workers facing shortages of protective gear
https://www.msn.com/en-us/news/us/coronavirus-pleas-go-out-for-healthcare-workers-facing-shortages-of-protective-gear/ar-BB11B5Uk

Many front line healthcare workers are very likely to be placed in situations where they must treat patients with insufficient protective equipment. Any comprehensive treatment strategy for SARS-CoV-2 at this point must in addition to the typical treatment algorithms also include the following.

1) Developing a plan for treatment when new supplies of typically disposable protective equipment cannot be obtained.
2) Assessing personnel risk and determining which personnel should or should not be allowed to enter situations that carry high risk for exposure.
3) Risk mitigation for the inevitable high numbers of healthcare worker who will contract this on the job.

I would make the case that immune boosting supplements fall into #3 and are therefore relevant to a discussion of treatment strategies for SARS-CoV-2. However, I realize that that this not the direction you want this thread to go in so I will refrain posting any further discussion of supplements in this thread.

Once more, as stated in the OP, this thread is for evidence based discussion about treatment strategies specific to SARS-CoV-2. Much like discussion surrounding the influenza vaccine on the previous page, discussion about vitamin C megadosing for the common cold is entirely off topic. There are plenty of other threads where such discussion would be more suitable.