Leronlimab discussed for potential inclusion by th
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Posted On: 05/19/2020 7:49:34 PM
Leronlimab discussed for potential inclusion by the WHO as a part of the Solidarity Trial:
From WHO R&D Blueprint COVID-19
https://www.who.int/docs/default-source/blue-...nload=true
Page 3:
OBJECTIVES OF THE CONSULTATION
There is a long list of potential immunomodulator candidates to be considered for the solidarity trial. Therefore, to facilitate the discussion, WHO secretariat has prepared a list (table) and summary fact sheets for candidates that are being used in some studies.........
Page 9 -10
Conclusions:
There are many studies ongoing in Europe (Italy and Spain) testing different types of immunomodulators. IL-6 inhibitors (e.g. Tocilizumad) are the most used in trials, preliminary results from a RCT in France shows some effect https://www.aphp.fr/contenu/tocilizumab-impro...e-covid-19. Though Sarilumab did not show a clear clinical benefit. https://www.sanofi.com/-/media/Project/One-Sa...288-en.pdf
There are some safety concerns about the use of immunomodulators, these immunotherapies have been approved for other diseases in a different context, and there are some risks in the context of severe pneumonia.
Current clinical trials in Italy and Spain showed an increase of infections, however these data are not being collected systemically since is not the main objective of the study. We also need to consider which population would really benefit for the type of therapies. However, these therapies may have some benefits in specific patients populations treated at the right stage of illness and this emphasizes the importance of having good quality of data from RCTs.
The Clinical Trial design Working Group will have a TC on 7th May to review the Solidarity protocol and discuss whether it needs to be adjusted if a new arm with immunomodulators would added including safety as an outcome.
The secretariat reminds to the members of the WG that the main objective of the call was not to make any choice at this stage, it is a preliminary step to develop a landscape of immunomodulator therapies.
PROPOSED NEXT STEPS
1. The secretariat will update the list with the therapies suggested during the call. (Famotidine, Leronlimab , Zilucoplan, GM-csf)
2. Members of the group should provide feedback in writing to the secretariat on what products would be the most suitable to further investigate/discuss, what should not be considered and provide the rationale. Members prioritize the list before the next call.
3. In a second round with a shorter list we can create a ranking to select the therapies for clinical trials
4. Next call in a week time.
Note that above prioritization decisions are preliminary and may change as further information is provided to WHO.
From WHO R&D Blueprint COVID-19
https://www.who.int/docs/default-source/blue-...nload=true
Page 3:
OBJECTIVES OF THE CONSULTATION
There is a long list of potential immunomodulator candidates to be considered for the solidarity trial. Therefore, to facilitate the discussion, WHO secretariat has prepared a list (table) and summary fact sheets for candidates that are being used in some studies.........
Page 9 -10
Conclusions:
There are many studies ongoing in Europe (Italy and Spain) testing different types of immunomodulators. IL-6 inhibitors (e.g. Tocilizumad) are the most used in trials, preliminary results from a RCT in France shows some effect https://www.aphp.fr/contenu/tocilizumab-impro...e-covid-19. Though Sarilumab did not show a clear clinical benefit. https://www.sanofi.com/-/media/Project/One-Sa...288-en.pdf
There are some safety concerns about the use of immunomodulators, these immunotherapies have been approved for other diseases in a different context, and there are some risks in the context of severe pneumonia.
Current clinical trials in Italy and Spain showed an increase of infections, however these data are not being collected systemically since is not the main objective of the study. We also need to consider which population would really benefit for the type of therapies. However, these therapies may have some benefits in specific patients populations treated at the right stage of illness and this emphasizes the importance of having good quality of data from RCTs.
The Clinical Trial design Working Group will have a TC on 7th May to review the Solidarity protocol and discuss whether it needs to be adjusted if a new arm with immunomodulators would added including safety as an outcome.
The secretariat reminds to the members of the WG that the main objective of the call was not to make any choice at this stage, it is a preliminary step to develop a landscape of immunomodulator therapies.
PROPOSED NEXT STEPS
1. The secretariat will update the list with the therapies suggested during the call. (Famotidine, Leronlimab , Zilucoplan, GM-csf)
2. Members of the group should provide feedback in writing to the secretariat on what products would be the most suitable to further investigate/discuss, what should not be considered and provide the rationale. Members prioritize the list before the next call.
3. In a second round with a shorter list we can create a ranking to select the therapies for clinical trials
4. Next call in a week time.
Note that above prioritization decisions are preliminary and may change as further information is provided to WHO.
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