Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05121740
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2021-11-08
Brief Title:
Extension Study in a Cohort of Adult Patients With COVID-19 Infection
Sponsor:
PharmaMar
Organization:
PharmaMar
Study Overview
Official Title:
Extension Study in a Cohort of Adult Patients With SARS-CoV-2 Infection Requiring Hospital Admission and Received Treatment With Plitidepsin in the APLICOV-PC Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-APLICOV-PC
Brief Summary:
The main objective of this study is to evaluate the incidence of post-COVID morbidity and characterize the complications profile in patients who participated in the APLICOV-PC study APLICOV-PC study was a multicenter randomized proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin 15 mg 20 mg and 25 mg administered three consecutive days in adult patients with confirmed diagnosis of COVID-19 who require hospital admission
Detailed Description:
The APLICOV-PC proof of concept study demonstrated the antiviral activity of plitidepsin in terms of reducing viral load inducing recovery and impact on lymphocyte reconstitution and other inflammatory parameters
A percentage of patients which varies between 10 and 25 continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection For some of them this significantly restricts their life requiring them to take long-term sickness leave from work and leaving them with sequelae that may continue for more than one year
With this study Pharmamar intends to evaluate whether the treatment with plitidepsin by attaining a reduction in the viral load and a faster recovery of the patient could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection
A percentage of patients which varies between 10 and 25 continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection For some of them this significantly restricts their life requiring them to take long-term sickness leave from work and leaving them with sequelae that may continue for more than one year
With this study Pharmamar intends to evaluate whether the treatment with plitidepsin by attaining a reduction in the viral load and a faster recovery of the patient could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-004966-37 | EUDRACT_NUMBER | None | None |