COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=018-20

Dra Ursula Rodriguez-Frias Rodriguez-Frias

ursula.rodriguezfrias@astrazeneca.com

2020-06-30

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Subjects are eligible to be included in the study only if all of the criteria below apply. 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). Clinical Study Protocol - 3.0 AstraZeneca Acalabrutinib - ACE-ID-201 (D822FC00001) CONFIDENTIAL AND PROPRIETARY 26 of 88 2. Men and women &#8805,18 years of age at the time of signing the Informed Consent Form (ICF). 3. SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization. 4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen. 5. Able to swallow pills. 6. Willing to follow contraception guidelines (refer to Appendix F).

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

2

Acerta Pharma; BV;

18

100

Argentina;Brazil;India;Chile;Germany;Italy;Japan;Mexico;Peru;Russia;South Africa;Spain;Sweden;Turkey

Severe disease at enrollment

6: Severe disease at enrollment

30

Outcome name:Investigator assessment based on Respiratory insuffiency in hospitalized patients due to COVID-19 InfectionMeasure:Proportion of subjects alive and free of respiratory failure at Day 14Timepoints:From randomization to day 14.

Phase 2

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