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

NCT ID: NCT04679350

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2022-12-30

Brief Summary

To 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

Detailed Description

A Multi center, Randomized, Double-blind, Parallel design

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard of care + 3 doses of hzVSF-v13 50 mg/dose IV

Standard of care + 3 doses of hzVSF-v13 50 mg/dose IV

Group Type: EXPERIMENTAL

hzVSF-v13

Intervention Type: DRUG

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)

Standard of care + 3 doses of hzVSF-v13 200 mg/dose IV

Standard of care + 3 doses of hzVSF-v13 200 mg/dose IV

Group Type: EXPERIMENTAL

hzVSF-v13

Intervention Type: DRUG

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)

Standard of care + 1 dose of hzVSF-v13 200 mg/dose IV + 2 doses of the placebo

Standard of care + 1 dose of hzVSF-v13 200 mg/dose IV + 2 doses of the placebo

Group Type: EXPERIMENTAL

hzVSF-v13

Intervention Type: DRUG

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)

Standard of care + 3 doses of the placebo to match hzVSF-v13 (normal saline)

Standard of care + 3 doses of the placebo to match hzVSF-v13 (normal saline)

Group Type: PLACEBO_COMPARATOR

Placebo (Normal saline solution)

Intervention Type: DRUG

Dosage form: 0.9% NaCl solution Frequency: Dose at Day 1, 3, 7

Interventions

hzVSF-v13

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)

Intervention Type: DRUG

Placebo (Normal saline solution)

Dosage form: 0.9% NaCl solution Frequency: Dose at Day 1, 3, 7

Intervention Type: DRUG

Other Intervention Names

a humanized monoclonal antibody (mAb); 0.9% Normal saline

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneMed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yeungnam University Medical Center

Daegu, , South Korea

Keimyung University Dongsan Hospital

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

IM_hzVSF_v13-0004

Identifier Type: -

Identifier Source: org_study_id