IRAK 4 Inhibitor (PF-06650833) in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation.

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: COVID-19 Pneumonia

In brief

The aim of the current clinical study is to evaluate the efficacy and safety of inhibition of Interleukin-1 receptor associated kinase 4 (IRAK4) in ameliorating the proinflammatory state and improving outcomes in severe COVID-19.

Key facts

Study ID

NCT04933799

Run by

Giovanni Franchin, M.D, Ph.D

People needed

68

Starts

2021-01-06

Expected to finish

2022-05-06

Last updated by the study team

2021-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalized adult male and female patients, including women of childbearing potential, at least 18 years of age, inclusive. Women of childbearing potential must agree to the protocol-specific contraception requirements.
• Participant (or legally authorized representative) capable of giving signed informed consent.
• Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection.
• Evidence of pneumonia assessed by ALL of the following:
• Radiographic imaging (eg, chest x-ray, chest computed tomography [CT] scan, etc.); AND
• Clinical assessment (evidence of rales/crackles on exam); AND
• SpO2 ≤94% on room air.
• Evidence of increased inflammation as assessed by hsCRP > ULN AND at least ONE of the following being > ULN (as available):
• Ferritin;
• Procalcitonin;
• D-dimer;
• Fibrinogen;
• LDH;
• PT/PTT.

You may not qualify if…

• Other medical condition other than COVID-19 or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study, eg, acute coronary syndrome.
• Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection) or fungal infections
• Active herpes zoster infection.
• Known active or latent tuberculosis (TB) or history of inadequately treated TB.
• Active hepatitis B or hepatitis C.
• Patients with positive hepatitis B surface antigen (HBsAg) will be excluded. Patients who are HBsAg negative but hepatitis B core antibody (HBcAb) positive will need a negative hepatitis B virus deoxyribonucleic acid (HBV DNA) to be allowed to enroll in the study; if the HBV DNA is positive, they will be not eligible.
• Patients with a positive test for hepatitis C virus (hepatitis C virus antibody; HCV Ab) will need a negative hepatitis C virus ribonucleic acid (HCV RNA; or negative HCV Ab test) and normal liver function (as assessed by liver transaminases and bilirubin within protocol-permitted limits, and no other evidence of compromised liver synthetic ability (eg, albumin and coagulation tests within protocol-permitted limits) to be allowed to enroll in the study, provided other eligibility criteria are met.
• Known history of human immunodeficiency virus (HIV) infection with a detectable viral load or CD4 count <500 cells/mm3 (or patients for whom documentation of viral load or CD4 counts are not available) will be excluded; patients on highly active anti retroviral treatment, undetectable HIV viral load, and CD4 counts ≥500 cells/mm3 would be eligible).
• Active hematologic cancer.
• Metastatic or intractable cancer.
• Pre-existing neurodegenerative disease.
• Proven bacterial pneumonia, other serious infection, sepsis, and/septic shock.
• Requirement for mechanical ventilation, or extracorporeal membrane oxygenation.
• Severe hepatic impairment defined as Child-Pugh Class B or Class C at baseline.
• Severe renal impairment with an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2.
• Known history of nephrolithiasis.
• Severe anemia (Hb <8.0 g/dL).
• Any of the following abnormal laboratory vales:
• Absolute lymphocyte count <500 cells/mm3;
• Absolute neutrophil count (ANC) <1500 cells/mm3;
• Platelet count <50,000 cells/mm3;
• ALT or AST >5X ULN, or total bilirubin >2X ULN, or other evidence of hepatocellular synthetic dysfunction.
• Any other medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Prohibited concomitant therapy.
• Pregnancy (a negative urine or serum pregnancy test is required for inclusion) or breastfeeding.

Where it is running

• Bronx-Lebanon Hospital Center Health Care System — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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