Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia

Inclusion Criteria:

1. Adults aged at least 19 years at screening

2. Those who have been admitted or scheduled to be admitted due to a diagnosis with
COVID-19 by RT-PCR test within 4 days prior to screening

3. Patients whose findings of COVID-19 pneumonia have been confirmed by radiographic
tests (CT and X-ray) at screening (e.g., ground glass opacity (GGO), crazy-paving
pattern, or consolidation)

4. Those who fall under the following at screening:

- Patients identified as moderate: Oxygen saturation in the atmosphere (SpO2) >93% (to
be confirmed with respiratory rate ≥20/min or pulse rate ≥90 beats/min secondarily)

- Patients identified as severe: Oxygen saturation in the atmosphere (SpO2) ≤93% or
PaO2/FiO2 <300 (respiratory rate ≥30/min or pulse rate ≥125 beats/min
secondarily)

5. Those who have voluntarily provided a written consent to participate in this clinical
study

Exclusion Criteria:

1. Individuals with a clinically significant history of hypersensitivity reactions to the
components of hzVSF-v13, drugs containing components of the same class, or other drugs
(aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)

2. Individuals with a severe at screening

- Breathing disorder that requires treatment of one or more of the following: Oxygen
therapy using high-flow nasal cannula (HFNC), Noninvasive positive pressure
ventilation (NIV), invasive mechanical ventilation, ECMO, Clinical diagnosis of
respiratory failure

- Shock (Systolic <90mmHg or diastolic <60mmHg, or in case need a blood pressure
booster)

- Multiple organ failure

3. Patients with pneumonia other than due to the novel coronavirus (SARS-CoV-2) infection
(e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia)

4. Patients with severe heart failure (NYHA Class III or higher)

5. Pregnant women

6. Men or women of childbearing potential who are planning to become pregnant or do not
agree to use one or more of the clinically appropriate methods of contraception below
from the first day until 120 days after the last day of investigational product
administration

① Surgical infertility (e.g., bilateral tubal ligation, vasectomy)

② Hormonal contraceptives (Hormone releasing IUD, implantable form, patch, oral
hormone)

③ Double-barrier method (concomitant use of two of the following: IUD, male or female
condom, contraceptive diaphragm, contraceptive sponge, cervical cap, spermicide)
Periodic abstinence (e.g., calendar, ovulation date, basal body temperature,
post-ovulation methods) and coitus interruptus are not permitted as appropriate
contraceptive methods, and effective contraceptive methods must be kept being used
during the course of the clinical study.

7. Those who are scheduled to have organ transplantation

8. Those who have laboratory test results that fall under the following values at
screening ① ALT or AST ≥5 times the upper limit of normal (ULN)

② eGFR < 30 mL/min/1.73m2

③ platelets < 50,000/mm3

9. Those who have a positive result for serology (hepatitis B, human immunodeficiency
virus [HIV], and hepatitis C tests) at screening

10. Those who administered other investigational products within 30 days prior to the
screening visit

11. Others who have been determined to be ineligible to participate in the clinical study
according to the investigator's medical opinion