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

NCT04679350 | Terminated Phase 2

• 1 other identifier: IM_hzVSF_v13-0004
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the clinical improvement score on an 8-point scale at Day 21

  Descriptive statistics for the changes from baseline in the clinical improvement score on an 8-point scale at Day 21 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.

  Day 21

Secondary Outcomes (6)

• Changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28

  Day 7, Day 14, Day 28

• Time to discontinuation of oxygen therapy after investigational product administration

  Day 28

• Time to recovery* after investigational product administration (days)

  Day 28

• Changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28

  Day 7, Day 14, Day 21, Day 28

• Changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28

  Day 7, Day 14, Day 21, Day 28

Study Arms (4)

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

EXPERIMENTAL

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

Drug: hzVSF-v13

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

EXPERIMENTAL

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

Drug: hzVSF-v13

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

EXPERIMENTAL

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

Drug: hzVSF-v13

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

PLACEBO COMPARATOR

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

Drug: Placebo (Normal saline solution)

Interventions

hzVSF-v13 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)

Also known as: 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 + 3 doses of hzVSF-v13 200 mg/dose IV; Standard of care + 3 doses of hzVSF-v13 50 mg/dose IV

Placebo (Normal saline solution) DRUG

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

Also known as: 0.9% Normal saline

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged at least 19 years at screening
• 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
• 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)
• 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)
• Those who have voluntarily provided a written consent to participate in this clinical study

You may not qualify if:

• 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.)
• 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
• Patients with pneumonia other than due to the novel coronavirus (SARS-CoV-2) infection (e.g., influenza virus pneumonia, bacterial pneumonia, and fungal pneumonia)
• Patients with severe heart failure (NYHA Class III or higher)
• Pregnant women
• 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.
• Those who are scheduled to have organ transplantation
• 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

Sponsors & Collaborators

• ImmuneMed, Inc.: lead

Study Sites (3)

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 22, 2020
• Study Start: March 18, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)