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

NCT04441385 | Terminated Phase 2

• 2 other identifiers: MARACOVID2020-002011-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

COVID-19

Keywords

SARS-CoV-2; ARDS; Acute respiratory distress syndrome; maraviroc

Outcome Measures

Primary Outcomes (1)

• Proportion of patients developing severe ARDS.

  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.

  28 days

Secondary Outcomes (7)

• All-cause mortality.

  28 days

• Percentage of patients requiring tracheal intubation, use of Non-invasive Ventilation NIV or High Flow Nasal Cannula (HFNC) devices during the study period

  28 days

• Percentage of patients who progress to severe ARDS, death or ICU admission.

  28 days

• Differences in Time to Clinical Improvement

  28 days

• Change in clinical status of subject on a 7-point ordinal scale.

  28 days

Study Arms (2)

Test arm

EXPERIMENTAL

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

Control arm

OTHER

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

Interventions

Maraviroc 300 mg DRUG

Patients will receive maraviroc 300 mg twice daily for 14 days

Also known as: Celsentri, Selzentry

Test arm

Standard care therapy OTHER

Subjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.

Control arm

Eligibility Criteria

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

You may qualify if:

• \. Male or female adult ≥ 18 years of age at the time of giving informed consent.
• \. Subject is hospitalized.
• \. 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.
• \. Lung involvement confirmed by at least one of the following criteria:
• Radiological infiltrates on imaging test (conventional radiography, computed tomography (CT) or other)
• 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.
• \. Symptom onset ≤ 8 days prior to randomization.
• \. Understands and agrees to comply with planned study procedures.
• \. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.

You may not qualify if:

• \. SpO2 ≤ 91% breathing ambient air and SpO2 \< 95% with oxygen in nasal cannula at 2 lpm.
• \. Patient's attending physician considers the study is not the best medical option, or follow-up after discharge will be difficult.
• \. Patients with severe chronic kidney disease (ClCr \< 30 ml/min/1.73 m2 or receiving renal replacement therapy in any of its modalities).
• \. Severe liver disease (Child-Pugh C, ALT \> 5 times above upper limit of normal (LSN).
• \. COPD with FEV1 \< 70.
• \. Known active neoplasia.
• \. Hemoglobin \< 9 gr/dL.
• \. 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.
• Significant cardiovascular disease, including:
• History of acute myocardial infarction, acute coronary syndrome (unstable angina, coronary by-pass surgery, angioplasty, or coronary stenting) ≤ 6 months prior to randomization
• 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).
• \. Known or suspected active autoimmune disease
• \. Pregnancy or breastfeeding, or positive pregnancy test at baseline or screening visit
• \. Patients who have a history of allergic reactions to maraviroc or any of its components.

Sponsors & Collaborators

• Hospital Universitario Infanta Leonor: lead
• Hospital Clinic of Barcelona: collaborator
• ViiV Healthcare: collaborator

Study Sites (2)

Hospital Clínic

Barcelona, 08036, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Víctor Domínguez, MD

  Hospital Universitario Infanta Leonor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: June 26, 2020
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: March 11, 2022

Record last verified: 2020-07

Locations

ES (2)