A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19

Key Inclusion Criteria:

1. Hospitalized patient with clinically diagnosis of SARS-CoV-2 virus infection per World
Health Organization criteria including positive nucleic acid test of any specimen
(e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to
screening.{Other confirmatory test results will be accepted upon approval from
Sponsor/CRO Medical Monitor prior to enrolment}.

2. Symptoms suggestive of moderate systemic illness with COVID-19, which could include
any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle
pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory
distress.

3. Clinical signs indicative of moderate systemic COVID-19 illness (with high risk of
developing severe ARDS/septic shock) with an aggregate of NEWS-2 score of 4-6 or 3 in
one single parameter.

Key Exclusion Criteria:

Patients who meet any of the following criteria will be disqualified from entering the
study:

1. Patients who require endotracheal intubation and mechanical ventilation, oxygen
delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via
reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥
0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of
respiratory failure.

2. Presence of any of the following abnormal laboratory values at screening: aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) >5 x upper limit of normal
(ULN), platelets <50,000/µL.

3. Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors in
the past 30 days or plans to receive during the study period.

4. Current treatment with conventional synthetic disease-modifying antirheumatic drugs
(DMARDs)/immunosuppressive agents.

5. Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose
higher than prednisone 10 mg or equivalent per day.

6. History of, or current autoimmune or inflammatory systemic or localized disease(s)
other than rheumatoid arthritis.