Log in
Register|
Silvia Giarcovich ☆ Argentina, 2020-04-17 00:38 (1848 d 20:59 ago) Posting: # 21333 Views: 6,792 |
|
|
Hi, in order to be able to start a new BE study I wonder as an exceptional consideration: Could the Clinical step of a BE study (screening, recruiting, administration of formulations and blood samples extractions) be carried out maintaining the HV at their own homes (always with a nurse at all times and a medical doctor visiting all the volunteers, etc etc)? I understand this is not an easy point since Clinical centers had already been certified (by our argentinian sanitary authority) and now we are proposing just forget about certifications and allow HV to stay at home while participating in a BE study. However, we are in a world wide sanitary emergency situation that will last a lot yet, at least until we could certify safety admission of healthy volunteers at Clinical centers. Besides the issue of alternative clinical sites -like home or a descentralized site- there is another point: how could be certified that a HV enters and finishes a BE study as a HV? One possibility would be to include a PCR / COVID-19 test both at screening and before each administration period and at the end of the study. This could be done only if the PCR / COVID-19 test is not a sanitary resource but an investigational one. Perhaps BE studies in HV could be safely carried out if a detailed risk/mitigation plan (in each step where a human subject participates) plus a PCR / COVID-19 test at several points are applied. Thanks a lot and regards, Silvia Edit: Two successive posts merged [Ohlbe] |
|
Ohlbe ★★★ France, 2020-04-20 12:11 (1845 d 09:25 ago) @ Silvia Giarcovich Posting: # 21337 Views: 4,128 |
|
|
Dear Silvia, ❝ Could the Clinical step of a BE study (screening, recruiting, administration of formulations and blood samples extractions) be carried out maintaining the HV at their own homes (always with a nurse at all times and a medical doctor visiting all the volunteers, etc etc)? Besides what you already mention (certification of clinical centres), I see several hurdles and I don't think what you propose would be feasible/acceptable for ethics committees and authorities:
Sorry but I think all we can do is be patient... — Regards Ohlbe |
|
jag009 ★★★ NJ, 2020-04-21 23:04 (1843 d 22:32 ago) @ Silvia Giarcovich Posting: # 21341 Views: 4,053 |
|
|
Hi, No. Too many uncertainties since I dont think we have a clear understanding of the route(s) of transmission yet. Also you are risking the safety of the staff (those who go to HV's home, as an example). J |
|
janejanesandpiper ☆ 
2021-05-26 18:26 (1444 d 03:10 ago) @ Silvia Giarcovich Posting: # 22368 Views: 3,158 |
|
|
SARS-COV-2 is optimized to bind to the ACE2 receptors. These receptors are all over the epithelial lining of your blood vessels (vascular system). Your blood vessels are the lifeline for ALL your organs. So when the virus “corrodes” the cells lining the blood vessels, you can see that clotting is rampant. Nitric Oxide (NO) prevents the oxidative stress that is caused by this virus to the blood vessel linings. NO supplementation (at hospitals through gas tanks is being done). This video explains it all. https://youtu.be/22Bn8jsGI54 Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Please follow the Forum’s Policy. [Helmut] |
|
drgunasakaran1 ★★  2021-06-03 08:06 (1436 d 13:31 ago) @ Silvia Giarcovich Posting: # 22389 Views: 3,110 |
|
|
Dear Ms Silvia Giarcovich, ❝ (always with a nurse at all times and a medical doctor visiting all the volunteers, etc etc)? It is highly advisable to keep the volunteers under the medical supervision of physicians for a specified period after administration of investigational product. Also, in case of any emergency, housing the subjects in their home is not practically safe to manage any serious adverse events. ❝ One possibility would be to include a PCR / COVID-19 test both at screening and before each administration period and at the end of the study. Yes. We can include negative RT-PCR as one of the subject's inclusion criteria during screening/each check-in/post study evaluation in the protocol itself to minimize the risk of infection/transmission of Coronavirus during the housing period. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz