Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04475991
Status:
TERMINATED
Last Update Posted:
2022-06-03
First Post:
2020-07-15
Brief Title:
Safety and Efficacy of Maraviroc andor Favipiravir With Standard Therapy in Severe COVID-19 Adults
Sponsor:
Hospital General de México Dr Eduardo Liceaga
Organization:
Hospital General de México Dr Eduardo Liceaga
Study Overview
Official Title:
Phase2 Randomized Controlled Study to Evaluate the Efficacy and Safety of Maraviroc andor Favipiravir Plus Standard Therapy in Adult Patients With Severe Non-critical COVID-19
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No more patients complying the selection criteria were available for recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMVIVIR
Brief Summary:
Phase 2 randomized open-label study to evaluate the safety and efficacy of maraviroc favipiravir and both drugs administered along with currently used therapy in hospitalized patients with pulmonary SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2 infection COVID-19
Detailed Description:
The COVID-19 pandemic Coronavirus Disease-19 caused by SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2 has caused more that 10 million infections worldwide with a general mortality of 6 Multiple studies have found that the hyperinflammatory immune response induced by SARS-CoV-2 is one of the main causes of severity and death in infected patients In severe COVID-19 patients an association was found between pneumonitis andor ARDS Acute Severe Respiratory Syndrome increased serum levels of cytokines and chemokines extensive lung damage and microthrombosis Studies of both gene expression in lungs and blood cytokines and chemokines have related chemokine signaling clusters with COVID-19 severity being CCL3 CCL4 and CCL7 CC chemokine ligands 3 4 and 7 particularly interesting All these are CCR5 CC chemokine receptor 5 ligands A strategy to modulate activation and trafficking of leukocytes to the lungs is by blocking CCR5 by using maraviroc MVC which has shown capable of modulating conditions of generalized inflammation Along with a good regulation of the immune response an antiviral that helps to reduce the viral load must be considered Favipiravir FPV has shown to be capable to reduce the time of viral clearance by half Hence we propose that the conjoint use of MVC and FPV could help to reduce the progression of severe hospitalized COVID-19 patients to critical by decreasing the percentage of patients in need of mechanical respiratory support or death by at least 30 This is a randomized controlled clinical trial that besides evaluating the safety and efficacy of MVCFPV to avoid progression in severe COVID-19 patients as a primary endpoint is also aimed at other secondary endpoints A Evaluate the activation of CCR5 in peripheral blood lymphocytes monocytes and neutrophils B Find possible modifications in the ongoing chemokine and cytokine storm in serum particularly IL-6 IL-1b interleukins 6 and 1 beta TNF tumor necrosis factor IFNa IFNg interferons alpha and gamma VEGF vascular endothelial growth factor CXCL10 CXC chemokine ligand 10 CCL7 CCL3 and CCL5 CC chemokine ligands 7 3 and 5 C Search for alterations in the patterns of activation trafficking and exhaustion of peripheral blood lymphocytes monocytes and neutrophils and D Determine if it has an effect in viral loads in saliva 100 severe patients tested positive for SARS-CoV-2 will be randomized in 4 treatment arms
Arm A Currently used therapy CT only Enoxaparin dexamethasone and antibiotics if associated bacteremia is present as per currently used at Hospital General de México Dr Eduardo Liceaga
Arm B CTMVC Arm C CTFPV Arm D CTMVCFPV
Arm A Currently used therapy CT only Enoxaparin dexamethasone and antibiotics if associated bacteremia is present as per currently used at Hospital General de México Dr Eduardo Liceaga
Arm B CTMVC Arm C CTFPV Arm D CTMVCFPV
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?:
False
Is an FDA AA801 Violation?:
None