CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Pembrolizumab (MK-3475)Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2527 Tocilizumab Wiki 0.19

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D011024 Pneumonia, Viral NIH 0.13
D011014 Pneumonia NIH 0.06

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials


1 A Randomized, Controlled, Open-Label, Phase II Trial to Evaluate the Efficacy and Safety of Tocilizumab Combined With Pembrolizumab (MK-3475) in Patients With Coronavirus Disease 2019 (COVID-19)-Pneumonia

This is a prospective, multicenter, randomized, controlled, open-label, phase 2 clinical trial

NCT04335305 COVID-19 Pneumonia, Viral Drug: Tocilizumab Biological: Pembrolizumab (MK-3475)
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Assessed by hospital records

Measure: Percentage of patients with normalization of SpO2 ≥96% on room air (measured without any respiratory support for at least 15 minutes

Time: through day 14 after study treatment initiation

Secondary Outcomes

Description: Assessed by hospital records

Measure: Proportion of patients discharged from the emergency department and classified as low risk

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: Assessed by hospital records

Measure: Number of days of patient hospitalization

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: The clinical status will be assessed by the SOFA scores

Measure: Change from baseline in organ failure parameters

Time: Days 1, 3, 5, 7, 14 (+/- 1 day) and 28 (+/- 2 days) or until discharge whatever it comes first.

Description: Determined as percentage of dead patients

Measure: Proportion of mortality rate

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: 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.

Measure: Analysis of the remission of respiratory symptoms

Time: through End of Study, defined as 90 ± 14 days after study entry

Description: by using the same imaging technique (chest X-ray or thoracic CT scan)

Measure: Evaluation of the radiological response

Time: at days 1 and 28 (+/- 2 days)

Description: determined using oropharyngeal or anal swabs

Measure: Time to first negative in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR test

Time: within 28 days from study inclusion

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of absolute lymphocyte count (ALC),white blood cell count and white blood cell differential count

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of hemoglobin

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of platelets

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of activated partial thromboplastin time (aPTT)

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of creatinine

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of glucose

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of total bilirubin

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Baseline defined as the value collected at day 1, 2 hours before treatment administration

Measure: Change from baseline of albumin

Time: days 3, 5, 7, 10, 14 and 28 after administration of study drug

Description: Evaluated using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0), SOFA scores.

Measure: Incidence of adverse events (AEs), incidence of prespecified AEs (safety and tolerability)

Time: Up to End of Study, defined as 90 ± 14 days after study entry


Related HPO nodes (Using clinical trials)