Maraviroc in Patients With Moderate and Severe COVID-19

Sponsor

Rhode Island Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04435522

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID	Drug: Maraviroc	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-Label Study of Maraviroc in Hospitalized Individuals Diagnosed With SARS-CoV-2

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maraviroc Treatment Maraviroc 300 mg Twice Daily	Drug: Maraviroc 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).

Arm

Intervention/Treatment

Experimental: Maraviroc Treatment

Maraviroc 300 mg Twice Daily

Drug: Maraviroc

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).

Outcome Measures

Primary Outcome Measures

Rate of Completion [7 days]
Rate of subjects who complete the 7-day course of Maraviroc without discontinuation for serious adverse event or death.
Clinical improvement at Day 7 [7 days]
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.

Secondary Outcome Measures

Change in Chitinase 3-like 1(Chi3l1) (ng/mL) [7 days]
Measurement of Chi3l1 before, during and at completion of therapy.
Change in Interleukin-6 (IL-6) (pg/mL) [7 Days]
Measurement of IL-6 before, during and at completion of therapy.
Change in CCL5 (RANTES) (ng/mL) [7 Days]
Measurement of CCL5 before, during and at completion of therapy.
Mortality [28 days]
7-, 14- and 28-day all-cause-mortality
Time to Discharge [28 days]
Time to improvement to Score of 2 or less (Days)
Days on mechanical ventilation [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rhode Island Hospital	Providence	Rhode Island	United States	02908

Sponsors and Collaborators

Rhode Island Hospital

Investigators

Principal Investigator: Philip A Chan, MD, Warren Alpert Medical School and School of Public Health, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rhode Island Hospital

ClinicalTrials.gov Identifier:

NCT04435522

Other Study ID Numbers:

1611471-1

First Posted:

Jun 17, 2020

Last Update Posted:

Feb 4, 2021

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Rhode Island Hospital

Maraviroc

CCR5 Antagonist

Additional relevant MeSH terms:

Maraviroc

Study Results

No Results Posted as of Feb 4, 2021