Tolerability and Efficacy of RJX in Patients With COVID-19

Exclusion Criteria

• •1. Receiving high-flow oxygen OR NIPPV. Cohort 1 and Cohort 2
• •2. ARDS by Berlin definition (Appendix 16.2)
• •3. On extracorporeal membrane oxygenation
• •4. Uncontrolled hypertension (systolic blood pressure \[BP\] \>150 mmHg and/or diastolic BP \>100 mmHg), unstable angina, congestive heart failure of New York Heart Association Classification Class III or IV (i.e., Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g., walking short distances \[20 100 m\], comfortable only at rest; Class IV: severe limitations, experiences symptoms even while at rest, mostly bedbound patients), serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 12 months prior to enrollment
• •5. Subjects with a history of congenital long QT syndrome or of Torsades de pointes; subjects with bradycardia (\<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only); subjects with any of the following findings on electrocardiogram (ECG): QTc interval \>470 msec in women OR \>450 msec in men; subjects requiring any drugs known to prolong the QTc interval, including antiarrhythmic medications
• •6. Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine
• •7. Renal function impairment with creatinine ≥2 mg/dL
• •8. Liver function impairment with total bilirubin ≥2 mg/dL
• •9. Platelet count \<50,000/µL
• •10. Multi-organ failure
• •11. History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation
• •12. Use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs, antibiotics, and antiviral drugs that are not part of the standard of care
• •13. Presence of any uncontrolled concomitant illness (e.g., bacterial sepsis or invasive fungal infection), or other serious illness and medical conditions, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with their participation in the study
• •14. Pregnancy or breast-feeding (for women)