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Maraviroc in Patients With Moderate and Severe COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435522
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc

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).




Primary Outcome Measures :
  1. Rate of Completion [ Time Frame: 7 days ]
    Rate of subjects who complete the 7-day course of Maraviroc without discontinuation for serious adverse event or death.

  2. Clinical improvement at Day 7 [ Time Frame: 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 :
  1. Change in Chitinase 3-like 1(Chi3l1) (ng/mL) [ Time Frame: 7 days ]
    Measurement of Chi3l1 before, during and at completion of therapy.

  2. Change in Interleukin-6 (IL-6) (pg/mL) [ Time Frame: 7 Days ]
    Measurement of IL-6 before, during and at completion of therapy.

  3. Change in CCL5 (RANTES) (ng/mL) [ Time Frame: 7 Days ]
    Measurement of CCL5 before, during and at completion of therapy.

  4. Mortality [ Time Frame: 28 days ]
    7-, 14- and 28-day all-cause-mortality

  5. Time to Discharge [ Time Frame: 28 days ]
    Time to improvement to Score of 2 or less (Days)

  6. Days on mechanical ventilation [ Time Frame: 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435522


Contacts
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Contact: Neel S Belani, MD 401-602-8526 neel_belani@brown.edu
Contact: Anshul Parulkar, MD 401-602-8526 anshul_parulkar@alumni.brown.edu

Locations
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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Rhode Island Hospital
Investigators
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Principal Investigator: Philip A Chan, MD Warren Alpert Medical School and School of Public Health, Brown University
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT04435522    
Other Study ID Numbers: 1611471-1
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rhode Island Hospital:
Maraviroc
CCR5 Antagonist
Additional relevant MeSH terms:
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Maraviroc
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists