Clinical trial NCT04679350: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: ImmuneMed, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Changes from baseline in the clinical improvement score on an 8-point scale at Day 21
timeFrame: Day 21
Secondary outcomes:
measure: Changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28
timeFrame: Day 7, Day 14, Day 28
measure: Time to discontinuation of oxygen therapy after investigational product administration
timeFrame: Day 28
measure: Time to recovery* after investigational product administration (days)
timeFrame: Day 28
measure: Changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28
timeFrame: Day 7, Day 14, Day 21, Day 28
measure: Changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28
timeFrame: Day 7, Day 14, Day 21, Day 28
measure: Mortality at Day 28 and Day 60 after investigational product administration
timeFrame: Day 28, Day 60
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
References: