This is a prospective, multicenter, randomized, controlled, open-label, phase 2 clinical trial
The aim of this study is to assess the efficacy -as determined by the proportion of patients with normalization of SpO2 ≥96% on room air- of continued standard care together with tocilizumab plus pembrolizumab (MK- 3475) in patients with COVID-19 pneumonia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IV infusion over 60 minutes; 8 mg/kg (up to a maximum of 800 mg per dose); single dose
IV infusion over 30 minutes, 200 mg; single dose
Hospital Quirónsalud Barcelona
Barcelona, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Ruber Juan Bravo
Madrid, Spain
Percentage of patients with normalization of SpO2 ≥96% on room air (measured without any respiratory support for at least 15 minutes
Assessed by hospital records
Time frame: through day 14 after study treatment initiation
Proportion of patients discharged from the emergency department and classified as low risk
Assessed by hospital records
Time frame: through End of Study, defined as 90 ± 14 days after study entry
Number of days of patient hospitalization
Assessed by hospital records
Time frame: through End of Study, defined as 90 ± 14 days after study entry
Change from baseline in organ failure parameters
The clinical status will be assessed by the SOFA scores
Time frame: Days 1, 3, 5, 7, 14 (+/- 1 day) and 28 (+/- 2 days) or until discharge whatever it comes first.
Proportion of mortality rate
Determined as percentage of dead patients
Time frame: through End of Study, defined as 90 ± 14 days after study entry
Analysis of the remission of respiratory symptoms
Determined as: * Time to invasive mechanical ventilation (if not previously initiated); * Time to independence from non-invasive mechanical ventilation; * Time to independence from oxygen therapy.
Time frame: through End of Study, defined as 90 ± 14 days after study entry
Evaluation of the radiological response
by using the same imaging technique (chest X-ray or thoracic CT scan)
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Hospital Ruber Internacional
Madrid, Spain
Hospital Arnau de Vilanova-Lliria
Valencia, Spain
Hospital Universitario Doctor Peset
Valencia, Spain
Time frame: at days 1 and 28 (+/- 2 days)
Time to first negative in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR test
determined using oropharyngeal or anal swabs
Time frame: within 28 days from study inclusion
Change from baseline of absolute lymphocyte count (ALC),white blood cell count and white blood cell differential count
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of hemoglobin
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of platelets
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of activated partial thromboplastin time (aPTT)
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of creatinine
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of glucose
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of total bilirubin
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Change from baseline of albumin
Baseline defined as the value collected at day 1, 2 hours before treatment administration
Time frame: days 3, 5, 7, 10, 14 and 28 after administration of study drug
Incidence of adverse events (AEs), incidence of prespecified AEs (safety and tolerability)
Evaluated using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0), SOFA scores.
Time frame: Up to End of Study, defined as 90 ± 14 days after study entry