Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585319
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study of Kitoscell LP pirfenidone LP Vs Collagen-polyvinylpyrrolidone As Treatment and Protection in Patients with Moderate to Severe COVID-19
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Collagen-polyvinylpyrrolidone collagen-PVP and pirfenidone have the ability to control cytokine storms This work explores the therapeutic effects of both on the early treatment of patients with severe COVID-19 The hospital stay quick COVID-19 severity index qCSI and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone compared to the controls treated with dexamethasone alone
Detailed Description:
The therapeutic target of COVID-19 is focused on the control of inflammation and the prevention of fibrosis Collagen-polyvinylpyrrolidone collagen-PVP and pirfenidone have the ability to control cytokine storms observed in rheumatic and fibrotic disorders In this work the investigators explored the therapeutic effects of both in addition to dexamethasone on the early treatment of patients with severe COVID-19 The hospital stay quick COVID-19 severity index qCSI and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone compared to the controls treated with dexamethasone alone Furthermore only collagen-PVP normalized serum glucose at discharge Since the intracellular mechanism of action of pirfenidone is partially known it was performed a whole human genome microarray assay with total RNA isolated from fibroblast and macrophage cultures treated with collagen-PVP Ingenuity Pathway Analysis showed that cell cycle inflammation and cell surface-extracellular matrix interaction could be regulated by the collagen-PVP copolymer by down-regulation of pro-inflammatory cytokines such as IL-6 and -8 while Th2 anti-inflammatory response signaling could be up-regulated Additionally down-regulation of some of the genes involved in nitric oxide production by inducible nitric oxide synthase showed a possible control for JAK in the IFN-γ pathway allowing the possibility of controlling inflammation through the JAKSTAT pathway as has been observed for pirfenidone and other immunomodulators such as ruxolitinib In summary once again collagen-PVP and pirfenidone have demonstrated to favor inflammatory control and stand out as a possible therapy for inflammatory disorders derived from viral or microorganism infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None