Status:
COMPLETED
Maraviroc in Patients With Moderate and Severe COVID-19
Lead Sponsor:
Rhode Island Hospital
Conditions:
COVID
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
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 infla...
Detailed Description
This pilot study seeks to establish that selective blockade of the CCR5/CCL5 axis as well as the potential anti-viral properties of Maraviroc may reduce disease severity. This proof-of-concept effort ...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years of age at time of screening
- Documentation of a SARS-CoV-2 diagnosis as evidenced by positive SARS-CoV-2 PCR within twelve days at time of screening
- Chest radiography consistent with multi-focal pneumonia or air-space disease
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Subject able to safely swallow pills or receive Maraviroc through a nasogastric or orogastric tube.
Exclusion
- Subjects who are pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Subjects with the presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. This includes, but is not limited to, recent myocardial infarction in past 6 months, neurological, psychiatric, endocrine, or neoplastic diseases that are judged to interfere with participation in the study.
- Subjects with known diagnosis of human immunodeficiency virus infection (HIV)
- Subjects enrolled in another clinical trial (including one for COVID-19) that excludes participation in other trials or includes a potent CYP3A inhibitor or inducer (e.g. lopinavir-ritonavir).
- Subjects with ESRD or severe renal failure who are taking potent (moderate or strong) CYP3A inhibitors or inducers
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04435522
Start Date
October 1 2020
End Date
December 31 2020
Last Update
April 29 2024
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02908