Maraviroc in Patients With Moderate and Severe COVID-19

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhode Island Hospital
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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