Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04435522
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2020-06-15
Brief Title:
Maraviroc in Patients With Moderate and Severe COVID-19
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Open-Label Study of Maraviroc in Hospitalized Individuals Diagnosed With SARS-CoV-2
Status:
COMPLETED
Status Verified Date:
2020-06
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:
None
Brief Summary:
Maraviroc a C-C Chemokine Receptor 5 CCR5 antagonist is well-tolerated without significant side effects in its current use in patients with HIV CCR5 antagonism prior to the second wave of inflammatory mediator expression in SARS-CoV-2 may reverse lymphoid depletion and may alter cell trafficking of inflammatory cells both increasing viral control capacity and dampening damage to lung tissue respectively This study seeks to establish whether one week of treatment with Maraviroc used at its approved dosage for HIV is safe and tolerable in patients with SARS-CoV-2
Detailed Description:
This pilot study seeks to establish that selective blockade of the CCR5CCL5 axis as well as the potential anti-viral properties of Maraviroc may reduce disease severity This proof-of-concept effort seeks to correlate differences in clinical outcomes to differential cytokine expression in the setting of CCR5 antagonism in patients infected with SARS-CoV-2 Maraviroc is FDA-approved for the treatment of CCR5-tropic HIV-1 and has a well-documented safety and tolerability record in previous trials in immunocompromised HIV patients Maraviroc was not shown to have significant effect on the QT segment can be delivered via oral formulation and can be delivered safely to both patients with end-stage renal disease and dependence on hemodialysis12 For these reasons Maraviroc is an ideal candidate to study as a potential therapy for hospitalized patients with moderate-to-severe COVID-19
The primary objective is to establish whether Maraviroc used at its approved dosage for HIV is safe tolerable and effective in hospitalized patients with SARS-CoV-2 The secondary objective is to investigate the relationship between reduction of inflammatory markers such as IL-6 CCL5 etc and clinical outcomes including avoidance of respiratory decompensation and death
This is a single-center single-arm open-label trial Sixteen hospitalized patients will be enrolled Screening data will be reviewed to determine subject eligibility Subjects who meet all inclusion criteria and none of the exclusion criteria will be approached for consent prior to entering the study Each subject will receive 7 days of Maraviroc twice daily Each subject will have blood samples checked at time of enrollment Day 0 Day 3 Day 7 and Day 15 or time of live discharge whichever comes first of the study The total duration of subject participation will be five weeks The total duration of the study is expected to be 16 weeks
The primary objective is to establish whether Maraviroc used at its approved dosage for HIV is safe tolerable and effective in hospitalized patients with SARS-CoV-2 The secondary objective is to investigate the relationship between reduction of inflammatory markers such as IL-6 CCL5 etc and clinical outcomes including avoidance of respiratory decompensation and death
This is a single-center single-arm open-label trial Sixteen hospitalized patients will be enrolled Screening data will be reviewed to determine subject eligibility Subjects who meet all inclusion criteria and none of the exclusion criteria will be approached for consent prior to entering the study Each subject will receive 7 days of Maraviroc twice daily Each subject will have blood samples checked at time of enrollment Day 0 Day 3 Day 7 and Day 15 or time of live discharge whichever comes first of the study The total duration of subject participation will be five weeks The total duration of the study is expected to be 16 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None