Maraviroc in Patients With Moderate and Severe COVID-19

NCT04435522 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 1611471-1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Keywords

Maraviroc; CCR5 Antagonist

Outcome Measures

Primary Outcomes (2)

• Rate of Completion

  Rate of subjects who complete the 7-day course of Maraviroc (or shorter if discharged from hospital prior to 7 days) without discontinuation for serious adverse event or death.

  7 days

• Clinical Improvement at Day 7

  Percent of patients at Day 7 from enrollment achieving reduction of two points on a seven-category ordinal scale (defined below). Ordinal scale: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities OR hospitalized pending disposition, not requiring COVID-related care; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and, 7, death.

  7 days

Secondary Outcomes (2)

• Mortality

  28 days

• Median Time to >= 2 Point Improvement in Clinical Score.

  28 Days

Study Arms (1)

Maraviroc Treatment

EXPERIMENTAL

Maraviroc 300 mg Twice Daily

Drug: Maraviroc

Interventions

Maraviroc DRUG

Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy. The cytokine panel will consist of CCL5, IL-6, and Chitinase 3-like 1(Chi3l1).

Maraviroc Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Philip Chan, M.D.
• Organization: Rhode Island Hospital

philip_chan@brown.edu

401-793-4859

Study Officials

• Philip A Chan, MD

  Warren Alpert Medical School and School of Public Health, Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)