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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients will receive maraviroc 300 mg twice daily for 14 days
Subjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.
Hospital Clínic
Barcelona, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
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.
Time frame: 28 days
All-cause mortality.
Time frame: 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
Time frame: 28 days
Percentage of patients who progress to severe ARDS, death or ICU admission.
Time frame: 28 days
Differences in Time to Clinical Improvement
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).
Time frame: 28 days
Change in clinical status of subject on a 7-point ordinal scale.
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.
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Time frame: 28 days
Percentage of patients requiring immunosuppressive/immunomodulatory treatment as a rescue medication.
Time frame: 28 days
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.
Classification according to the WHO toxicity scale
Time frame: 28 days