Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia

ImmuneMed

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo (Normal saline solution); Drug: hzVSF-v13

Study type: Interventional

Funder types: Industry

Identifiers

NCT04679415

hzVSF_v13-0007

Details and patient eligibility

About

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

Full description

Multi center, Randomized, Double-blind, Parallel group, Phase 2 clinical study

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

63 participants in 3 patient groups, including a placebo group

Standard of care + hzVSF-v13 200 mg at D1, hzVSF-v13 100mg at D3 and D7 IV

Experimental group

Description:

Drug: hzVSF-v13 Dosage form: hzVSF-v13 40mg/mL in a 5mL vial Frequency: Dose at Day 1, 3, 7 Other names: a humanized monoclonal antibody (mAb)

Treatment:

Drug: hzVSF-v13

Standard of care + hzVSF-v13 400 mg at D1, hzVSF-v13 200mg at D3 and D7 IV

Experimental group

Description:

Drug: hzVSF-v13 Dosage form: hzVSF-v13 40mg/mL in a 5mL vial Frequency: Dose at Day 1, 3, 7 Other names: a humanized monoclonal antibody (mAb)

Treatment:

Drug: hzVSF-v13

Standard of care + 3 doses of the placebo (normal saline) IV

Placebo Comparator group

Description:

Drug: Placebo (Normal saline solution) Dosage form: 0.9% NaCl Solution Frequency Frequency: Dose at Day 1, 3, 7 Other names: 0.9% Normal saline

Treatment:

Drug: Placebo (Normal saline solution)