Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 90 years at the Screening assessment

2. Weight ≥ 50 kg at randomization

3. Hospitalized with a diagnosis of COVID-19 and in need of inpatient medical care

4. Positive for SARS-CoV-2 on nasopharyngeal, oropharyngeal or other tissue/body fluid
samples by PCR or validated other test of ongoing infection (not an antibody test for
prior exposure), within seven (7) days of hospitalization or screening assessment

5. D-dimer level > upper limit of normal at screening

6. Provided electronic or written informed consent, either personally or through a
legally authorized representative (LAR)

7. Must agree not to participate in a concurrent interventional study involving
anticoagulation or anti-platelet therapy

8. Female patients of reproductive or child-bearing potential must be willing to use an
effective method of contraception for the duration of the study, and male patients
must be willing to use an effective method of contraception to avoid partner pregnancy
and abstain from sperm donation for at least 90 days after last dose

Exclusion Criteria:

1. High bleeding risk, e.g. major surgery within prior 1 month, history of a major bleed
while receiving anticoagulation, recent hemorrhagic stroke, current or planned (during
current hospitalization) dual anti-platelet therapy, platelet count <25,000/uL,
current therapeutic anticoagulation for a medical indication other than COVID-19, e.g.
atrial fibrillation, known thrombosis, hereditary or acquired coagulopathy treated
with therapeutic anticoagulation. Patients receiving prophylactic anticoagulation are
eligible if they are willing to discontinue current anticoagulation.

2. Sustained systolic blood pressure < 90 mmHg considered to be clinically significant

3. Persistent eGFR <20 ml/min/1.73m2

4. Known severe liver disease (e.g. bilirubin >3.5 mg/dL (60 umol/L))

5. Life expectancy estimated to be < 72 hours based on current clinical condition

6. Anticipated hospital discharge or transfer within 5 days based on current clinical
condition

7. Known anti-phospholipid syndrome

8. Unable to receive heparin, e.g. history of heparin-induced thrombocytopenia and
thrombosis (HITT)

9. Participation in any interventional clinical study with an investigational product
within seven (7) days of the Screening assessment or within 5 half-lives of the
investigational agent, whichever is longer