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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04679350
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
ImmuneMed, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: hzVSF-v13 Drug: Placebo (Normal saline solution) Phase 2

Detailed Description:
A Multi center, Randomized, Double-blind, Parallel design
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi Center, Randomized, Double-blind, Parallel Design, Phase 2 Study to Evaluate the Efficacy and Safety of hzVSFv13 Compared to Standard of Care After Intravenous(IV) Administration With Add-on Standard of Care in COVID-19 Moderate to Severe Patients
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard of care + 3 doses of hzVSF-v13 50 mg/dose IV
Standard of care + 3 doses of hzVSF-v13 50 mg/dose IV
 Drug: 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)
Other Name: a humanized monoclonal antibody (mAb)
Experimental: Standard of care + 3 doses of hzVSF-v13 200 mg/dose IV
Standard of care + 3 doses of hzVSF-v13 200 mg/dose IV
 Drug: 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)
Other Name: a humanized monoclonal antibody (mAb)
Experimental: 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
 Drug: 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)
Other Name: a humanized monoclonal antibody (mAb)
Placebo Comparator: 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)
 Drug: Placebo (Normal saline solution)
Dosage form: 0.9% NaCl solution Frequency: Dose at Day 1, 3, 7
Other Name: 0.9% Normal saline


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline in the clinical improvement score on an 8-point scale at Day 21 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28 [ Time Frame: Day 7, Day 14, Day 28 ]
    Descriptive statistics for the changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon ranksum 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.

  2. Time to discontinuation of oxygen therapy after investigational product administration [ Time Frame: Day 28 ]
    The Kaplan-Meier curves for the time to discontinuation of oxygen therapy after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.

  3. Time to recovery* after investigational product administration (days) [ Time Frame: Day 28 ]
    *0 to 3 points in the clinical improvement score on an 8-point scale The Kaplan-Meier curves for the time to recovery after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.

  4. Changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28 [ Time Frame: Day 7, Day 14, Day 21, Day 28 ]
    Descriptive statistics for the changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28 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.

  5. Changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28 [ Time Frame: Day 7, Day 14, Day 21, Day 28 ]
    Descriptive statistics for the changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28 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.

  6. Mortality at Day 28 and Day 60 after investigational product administration [ Time Frame: Day 28, Day 60 ]
    The frequency and percentage for the proportion of subjects who died at Day 28 and Day 60 after investigational product administration shall be presented for each treatment group, and the Pearson's chi-squared test or the Fisher's exact test shall be performed to test differences of each study group compared to the control group.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679350


Contacts
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Contact: Byoungok Ahn, phD +82-2-527-8391 ahnbo@immunemed.co.kr

Locations
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Korea, Republic of
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 42415
Contact: Kwan Ho Lee, phD         
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of, 42601
Contact: Jae Seok Park, phD         
Chungnam National University Hospital Not yet recruiting
Daejeon, Korea, Republic of, 35015
Contact: Yeon Suk Kim, phD         
Sponsors and Collaborators
ImmuneMed, Inc.
Investigators
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Study Chair: Jihoon Hwang Linical Korea Co., Ltd.
More Information
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Responsible Party: ImmuneMed, Inc.
ClinicalTrials.gov Identifier: NCT04679350    
Other Study ID Numbers: IM_hzVSF_v13-0004
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases