Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04500418
Status:
TERMINATED
Last Update Posted:
2022-03-29
First Post:
2020-08-04
Brief Title:
Charité Trial of Cenicriviroc CVC Treatment for COVID-19 Patients
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Charité Trial of Cenicriviroc CVC Treatment for COVID-19 Patients
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Despite multiple efforts no further patient could be enrolled since 03052021 A continuation of the study is therefore no longer justified
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to test Cenicriviroc CVC as a means to reduce the severity of the lung disease COVID-19 caused by an infection with SARS-CoV-2 The safety of CVC when administered to COVID-19 patients will also be assessed Furthermore the clinical trial aims to answer the question of whether patients with pre-existing conditions who have an increased risk of severe COVID-19 progression benefit more and particularly from CVC CVC is an orally available dual inhibitor of the chemokine receptors CCR2 and CCR5 which is expected to reduce hyper- inflammation in COVID-19
The main goal of the study is to determine whether CVC helps increase the number of patients who are symptom-free and not hospitalized after 14 days compared to a placebo Approximately 667 of the patients enrolled in the study will receive CVC and 333 will get an optically identical pill placebo
Subjects will be assessed daily while hospitalized Discharged patients will be asked to attend study visits at Days 8 15 22 and 29 and 85 All subjects will undergo a series of clinical safety and laboratory assessments Blood samples and oropharyngeal OP swabs will be obtained on Day 1 3 5 while hospitalized and Day 8 15 and 29 if able to return to clinic or still hospitalized The presence of anti-SARS-CoV-2 antibodies will be determined on Days 29 and 85
The main goal of the study is to determine whether CVC helps increase the number of patients who are symptom-free and not hospitalized after 14 days compared to a placebo Approximately 667 of the patients enrolled in the study will receive CVC and 333 will get an optically identical pill placebo
Subjects will be assessed daily while hospitalized Discharged patients will be asked to attend study visits at Days 8 15 22 and 29 and 85 All subjects will undergo a series of clinical safety and laboratory assessments Blood samples and oropharyngeal OP swabs will be obtained on Day 1 3 5 while hospitalized and Day 8 15 and 29 if able to return to clinic or still hospitalized The presence of anti-SARS-CoV-2 antibodies will be determined on Days 29 and 85
Detailed Description:
None
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 |
|---|---|---|---|
| 2020-001493-29 | EUDRACT_NUMBER | None | None |