Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Covid-19
  Respiratory Failure
• Age: Between 18 years - 99 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Subjects =18 years of age at time of enrollment.
  2. Subjects who are confirmed COVID-19 disease
  3. Subjects with respiratory failure manifesting as: Acute Respiratory Distress Syndrome, OR SpO2 <90% on 4L OR increasing Oxygen requirements over 24 hours.
  4. Subjects who meets 2 or more of the following predictors for severe disease:
     • CRP > 35 mg/L
     • Ferritin > 500 ng/mL
     • D-dimer > 1 mcg/L
     • Neutrophil-Lymphocyte Ratio > 4
     • LDH > 200 U/L
     • Increase in troponin in patient w/out known cardiac disease
  5. Subjects who have consent designees willing to provide informed consent on behalf of the subjects
  6. Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period of 5 months following the study drug administration such as:
     • Combined hormonal contraception (oral, intravaginal, or transdermal)
     • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
     • intrauterine device (IUD)
     • intrauterine hormone-releasing system (IUS)
     • vasectomized partner
     • bilateral tubal occlusion
     • true abstinence
  7. Men must be willing to use a double-barrier contraception from enrollment until at 5 months after the last dose of study drug, if not abstinent.

  
  

You may not be eligible for this study if the following are true:

• 1. Subjects with evidence of irreversible injury deemed non-survivable even if the pulmonary failure recovers
  2. Subjects with known active inflammatory bowel disease
  3. Subjects with known active, untreated diverticulitis
  4. Subjects with known untreated bacteremia
  5. Subjects who is pregnant
  6. Subjects who have known hypersensitivity to the clazakizumab