Explore the efficacy and confirm the safety of the concomitant administration of the standard of care and hzVSF-v13 in patients with COVID-19 infection
Multi center, Randomized, Double-blind, Parallel group, Phase 2 clinical study
Drug: hzVSF-v13
Dosage form: hzVSF-v13 40 mg/mL in a 5 mL vial Frequency: Dose at Day 1, 3, 7
Other Name: a humanized monoclonal antibody (mAb)
Drug: Placebo (Normal saline solution)
Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7
Other Name: 0.9% Normal saline
Inclusion Criteria:
1. Adults aged at least 18 years at screening
2. Those who have been admitted or scheduled to be admitted due to a diagnosis with
moderate to severe 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%
(respiratory rate ≥20/min or pulse rate ≥90 beats/min secondarily)
- Patients identified as severe Oxygen saturation in the atmosphere (SpO2) < 93%
with (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. Patients with pneumonia other than due to the novel coronavirus (SARS-CoV-2) infection
(e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia)
3. Patients with severe heart failure (NYHA Class III or higher)
4. Pregnant women
5. Men and 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 Surgical infertility (e.g., bilateral tubal ligation, vasectomy)
Hormonal contraceptives (implantable form, patch, oral administration) Double-barrier
method (concomitant use of two of the following: IUD, male or female condom used with
spermicide, contraceptive diaphragm, contraceptive sponge, cervical cap)
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.
6. Those who are scheduled to have organ transplantation
7. Those who have laboratory test results that fall under the following values at
screening ALT or AST ≥5 times the upper limit of normal (ULN) eGFR < 30 mL/min/1.73m2
platelets < 50,000/mm3
8. Those who have a positive result for serology (hepatitis B, human immunodeficiency
virus [HIV], and hepatitis C tests) at screening
9. Those who received other investigational products within 30 days prior to the
screening visit
10. Others who have been determined to be ineligible to participate in the clinical study
according to the investigator's medical opinion, or subject who will/planned to be
transferred to other hospital within study period
Rumah Sakit Pusat Pertamina (include RSPP Extension Simprug)
Jakarta, Daerah Khusus Ibukota Jakarta, Indonesia
Rumah Sakit Pasar Minggu
Jakarta, Daerah Khusus Ibukota Jakarta, Indonesia
Rumah Sakit Umum Persahabatan
Jakarta, Daerah Khusus Ibukota Jakarta, Indonesia
Prasenohadi Prasenohadi, phD, Principal Investigator
Rumah Sakit Umum Persahabatan