IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC)

• Status: Terminated
• Trial end date: 2021-10-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Pfizer

Criteria

INCLUSION CRITERIA

1. Adult male and female patients, including women of childbearing potential, at least 18 years of age, inclusive

2. Participant (or legally authorized representative) capable of giving signed informed consent

3. Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection

4. Clinical findings and an imaging study consistent with ARDS;

5. PaO2 / FiO2 ratio < 300;

6. A requirement for mechanical ventilation ≤ 48 hours prior to enrollment.

7. Evidence of increased inflammation as assessed by hsCRP > ULN AND at least ONE of the following being > upper limit of normal (as available):

1. ferritin

2. procalcitonin

3. D-dimer

4. fibrinogen

5. LDH

6. PT/PTT

EXCLUSION CRITERIA

1. Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection), or fungal infections

2. Active herpes zoster infection

3. Known active or latent tuberculosis (TB) or history of inadequately treated TB

4. Active hepatitis B or hepatitis C

5. Known history of human immunodeficiency virus (HIV) infection with a detectable viral load or CD4 count < 500 cells / mm3 (patients for whom documented viral load or CD4 counts are available will be excluded)

6. Active hematologic cancer

7. Metastatic or intractable cancer

8. Pre-existing neurodegenerative disease

9. Severe hepatic impairment defined as Child-Pugh Class B or Class C at baseline

10. Severe renal impairment with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2

11. Severe anemia (Hb < 8.0 g/dL)

12. Any of the following abnormal laboratory values:

1. absolute lymphocyte count <250 cells/mm3

2. absolute neutrophil Count (ANC) <1000 cells/mm3

3. Platelet count <50,000 cells/mm3

4. ALT or AST > 5X ULN, or other evidence of hepatocellular synthetic dysfunction or total bilirubin > 2X ULN

13. 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

14. Prohibited concomitant therapy (see section 1.12.7.2)

15. Pregnancy (a negative urine or serum pregnancy test is required for inclusion)

16. Immunocompromised patients, patients with known immunodeficiencies or taking potent immunosuppressive agents (e.g., azathioprine, cyclosporine)

17. Anticipated survival < 72 hours as assessed by the Investigator.

18. Participation in other clinical trials of investigational treatments for COVID-19

19. Known history of nephrolithiasis