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Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19). (MARACOVID)

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: NCT04441385
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborators:
Hospital Clínic de Barcelona
ViiV Healthcare
Information provided by (Responsible Party):
Hospital Universitario Infanta Leonor

Brief Summary:
This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19).

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Maraviroc 300 mg Other: Standard care therapy Phase 2

Detailed Description:

This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19), to prevent disease progression to severe Acute Respiratory Distress Syndrome (ARDS).

Patients will be randomized to receive maraviroc (300 mg BID for 14 days) plus standard treatment, or standard treatment alone.

200 subjects will be enrolled and randomized 1:1 in this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bicentric, Phase 2, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc Associated With Standard Treatment in Hospitalized Patients With Pulmonary SARS-CoV-2 Infection (COVID-19).
Estimated Study Start Date : June 26, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 20, 2020


Arm Intervention/treatment
Experimental: Test arm
100 subjects will be randomly assigned to this arm. Patients in the test group will receive 300 mg of maraviroc BID for 14 days (added to standard care).
Drug: Maraviroc 300 mg
Patients will receive maraviroc 300 mg twice daily for 14 days
Other Names:
  • Celsentri
  • Selzentry

Control arm
100 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health has issued detailed guidelines for the management of COVID-19. Local Institutional Guidelines and Protocols for supportive management will also be implemented.
Other: Standard care therapy
Subjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.




Primary Outcome Measures :
  1. Proportion of patients developing severe ARDS. [ Time Frame: 28 days ]
    A patient with a saturation of 90% or less despite the use of a reservoir mask without rebreathing with a flow of 7 liters per minute (FiO2 0.6 or higher), will be considered to have severe ARDS. These oximetric criteria have a close correlation with a PaO2 / FiO2 of 100 or less, which defines severe ARDS.


Secondary Outcome Measures :
  1. All-cause mortality. [ Time Frame: 28 days ]
  2. Percentage of patients requiring tracheal intubation, use of Non-invasive Ventilation NIV or High Flow Nasal Cannula (HFNC) devices during the study period [ Time Frame: 28 days ]
  3. Percentage of patients who progress to severe ARDS, death or ICU admission. [ Time Frame: 28 days ]
  4. Differences in Time to Clinical Improvement [ Time Frame: 28 days ]

    Defined as the time (in hours) from the start of the treatment under study to the normalization of temperature, normalization of respiratory rate and SpO2.

    1. Axillary temperature < 37.5ºC (oral < 37.2ºC) for 48 hours, without antipyretic treatment.
    2. Breathing rate < 24 rpm during the clinical evaluation and at least two consecutive daily evaluations (48 hours).
    3. SpO2 > 93% breathing ambient air during clinical assessment and at least two consecutive daily assessments (48 hours).

  5. Change in clinical status of subject on a 7-point ordinal scale. [ Time Frame: 28 days ]

    The ordinal scale of 7 categories of patient health status ranges from:

    1. Death.
    2. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    3. Hospitalized, with non-invasive ventilation or high flow oxygen devices.
    4. Hospitalized, requiring supplemental oxygen.
    5. Hospitalized, not requiring supplemental oxygen.
    6. Non-hospitalized, activity limitation.
    7. Non-hospitalized, no activity limitation.

  6. Percentage of patients requiring immunosuppressive/immunomodulatory treatment as a rescue medication. [ Time Frame: 28 days ]
  7. Proportion of patients developing adverse effects, serious adverse reactions, laboratory or physical examination findings, EKG abnormalities acquired during the trial, death and adverse events leading to early discontinuation of treatment. [ Time Frame: 28 days ]
    Classification according to the WHO toxicity scale



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Male or female adult ≥ 18 years of age at the time of giving informed consent.
  • 2. Subject is hospitalized.
  • 3. SARS-CoV-2 infection confirmed by PCR or other commercial or public health tests, in any biological sample obtained up to 4 days prior to randomization, or that meets locally accepted criteria for clinical diagnosis of COVID-19.
  • 4. Lung involvement confirmed by at least one of the following criteria:

    1. Radiological infiltrates on imaging test (conventional radiography, computed tomography (CT) or other)
    2. In the absence of radiological infiltrates, an SpO2 < 95% without oxygen supporting therapy (breathing ambient air), combined with cough, crackles on physical exam, or an LDH > 300 U/L with no other cause.
  • 5. Symptom onset ≤ 8 days prior to randomization.
  • 6. Understands and agrees to comply with planned study procedures.
  • 7. Women of childbearing potential must have a negative test for pregnancy (blood or urine) before their inclusion and agree to use an accepted method of contraception for the duration of the study.
  • 8. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

  • 1. SpO2 ≤ 91% breathing ambient air and SpO2 < 95% with oxygen in nasal cannula at 2 lpm.
  • 2. Patient's attending physician considers the study is not the best medical option, or follow-up after discharge will be difficult.
  • 3. A patient who, in the investigator's opinion, is unlikely to survive > 48 hours from inclusion in the study.
  • 4. Patients with severe chronic kidney disease (ClCr < 30 ml/min/1.73 m2 or receiving renal replacement therapy in any of its modalities).
  • 5. Severe liver disease (Child-Pugh C, ALT > 5 times above upper limit of normal (LSN).
  • 6. COPD with FEV1 < 70.
  • 7. Known active neoplasia.
  • 8. HIV infection. Patients with known HIV infection, under follow-up, and immunovirological stability (CD4> 500 and undetectable viral load) for at least 6 months before inclusion in this study may be included.
  • 9. Hemoglobin < 9 gr/dL.
  • 10. Prolonged QT, defined as a QT interval > 460 ms. (or > 450 ms. in case of family history of sudden death or long QT syndrome or personal history of repeat syncope without an etiological diagnosis). This criterion will only apply if the standard treatment contains drugs with an effect on the duration (prolongation) of the QT interval.
  • 11.Significant cardiovascular disease, including:

    1. History of acute myocardial infarction, acute coronary syndrome (unstable angina, coronary by-pass surgery, angioplasty, or coronary stenting) ≤ 6 months prior to randomization
    2. Symptomatic heart failure (NYHA grade 2 or more) history, or current evidence of cardiac arrhythmia (except atrial fibrillation or flutter and paroxysmal supraventricular tachycardia) and/or conduction abnormalities (excluding branch blocks or Wenckebach grade I and II atrioventricular blocks).
  • 12. Known or suspected active autoimmune disease
  • 13. Pregnancy or breastfeeding, or positive pregnancy test at baseline or screening visit
  • 14. Patients who are expected to be transferred to another facility sooner than 72 hours after inclusion in the study.
  • 15. Patients who have received experimental treatment (off-label, compassionate use, or in clinical trials) within 30 days prior to the screening visit, except for treatment considered standard initiated on admission to hospital, up to 48 hours before inclusion in the study.
  • 16. Patients who have a history of allergic reactions to maraviroc or any of its components.

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): NCT04441385


Contacts
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Contact: Rosa María Muñoz +34 93 22 75 400 ext 4132 rmmunoz@clinic.cat

Locations
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Spain
Hospital Clínic
Barcelona, Spain, 08036
Contact: Felipe García, PhD, MD    932275400      
Principal Investigator: Felipe García, PhD, MD         
Sub-Investigator: Berta Torres, PhD, MD         
Sub-Investigator: Montserrat Laguno, PhD, MD         
Sub-Investigator: Álex Soriano, PhD, MD         
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Contact: Victor Domínguez, MD    +3491191900    vdominguezblasco@gmail.com   
Principal Investigator: Victor Domínguez, MD         
Sub-Investigator: Guillermo Cuevas, MD         
Sub-Investigator: Pablo Ryan, MD         
Sub-Investigator: Jesus Troya, MD         
Sponsors and Collaborators
Hospital Universitario Infanta Leonor
Hospital Clínic de Barcelona
ViiV Healthcare
Investigators
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Principal Investigator: Víctor Domínguez, MD Hospital Universitario Infanta Leonor
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Responsible Party: Hospital Universitario Infanta Leonor
ClinicalTrials.gov Identifier: NCT04441385    
Other Study ID Numbers: MARACOVID
2020-002011-21 ( EudraCT Number )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hospital Universitario Infanta Leonor:
SARS-CoV-2
ARDS
Acute respiratory distress syndrome
maraviroc
Additional relevant MeSH terms:
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Infection
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