Immune Modulators for Treating COVID-19

Exclusion Criteria

• •1. ALT or AST \>10 times the upper limit of normal.
• •2. Estimated glomerular filtration rate (eGFR) \<30 mL/min (including patients receiving hemodialysis or hemofiltration).
• •Exception: Participants with an eGFR \<30 mL/min may enroll as long as their renal insufficiency has been stable without renal replacement therapy for ≥1 month and they are not current candidates for renal replacement therapy. These participants will not receive remdesivir.
• •3. Neutropenia (absolute neutrophil count \<1000 cells/μL) (\<1.0 x 103/μL or \<1.0 GI/L).
• •4. Lymphopenia (absolute lymphocyte count \<200 cells/μL) (\<0.20 x 103/μL or \<0.20 GI/L)
• •5. Pregnancy or breast feeding.
• •6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
• •7. Known allergy to any study medication.
• •8. Received cytotoxic or biologictargeted immune-modulator treatments (such as anti-interleukin-1 \[IL-1\], anti-IL-6 \[tocilizumab or sarilumab\], anti-IL-17, or T-cell or B-cell targeted therapies (\[e.g., rituximab), tyrosine kinase\], JAK inhibitors \[including baricitinib,\], TNF inhibitors, or interferon) within 4 weeks or 5 half-lives prior to screening., whichever is longer. Steroid dependency, defined as need for prednisone at a dose \>10 mg (or equivalent) for \>1 month within 2 weeks of screening, is exclusionary. Note Exception 1: Dexamethasone (at a dose of 6 mg per day for up to 10 days) is permitted for the treatment of COVID-19 in patients who are already mechanically ventilated and in patients who require supplemental oxygen at screening, but who are not mechanically ventilated in accordance with national guidelines. Note Exception 2: Infusion of convalescent plasma given for treatment of COVID-19 while on-study is also allowed.
• •Exception 3: Monoclonal antibody therapy given for COVID-19 treatment at any time prior to enrollment is also allowed.
• •9. BasedKnown or suspected history of untreated tuberculosis (TB). TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection, have suspected clinical diagnosis of current active tuberculosis (TB) or, if. Participants are also excluded if they have known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
• •10. Based on medical history and concomitant therapies that would suggest infection,Known or suspected serious, active bacterial, fungal, or viral (infection (excepting SARS-CoV-2 and including, but not limited to, active HBV, HCV, or HIV/AIDS). with the latter defined as a CD4 count \<200 or an unsuppressed HIV viral load), or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
• •Note: Broad-spectrum empiric antibiotic usage does not exclude participation.
• •11. Have received any live vaccine (that is,or live attenuated) within 3 months before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note Exception: Use of prior non-live (inactivated) vaccinations is allowed for all participants, including any vaccine for COVID-19.
• •12. Severe hepatic impairment (defined as liver cirrhosis Child stage C).
• •13. CurrentKnown severe heart failure (New York Heart Association \[NYHA\] III-IV).) or new-onset left-systolic or global cardiac dysfunction in the setting of COVID-19.
• •Exception: Right-sided heart dysfunction or pulmonary hypertension thought related to COVID-19 is permitted.
• •14. In the Investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.