Clinical trial NCT04679415: Efficacy and Safety of hzVSF-v13 in Moderate to Severe 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: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: ImmuneMed, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical failure rate at Day 28
timeFrame: Day 28
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: Time to Clinical Improvement from randomization to clinical improvement (2 points decreased from the baseline score) (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, and 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
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Rumah Sakit Pusat Pertamina (include RSPP Extension Simprug)
state: Daerah Khusus Ibukota Jakarta
city: Jakarta
country: Indonesia
facility: Rumah Sakit Pasar Minggu
state: Daerah Khusus Ibukota Jakarta
city: Jakarta
country: Indonesia
facility: Rumah Sakit Umum Persahabatan
state: Daerah Khusus Ibukota Jakarta
Study officials:
affiliation: Rumah Sakit Umum Persahabatan
name: Prasenohadi Prasenohadi, phD
role: PRINCIPAL_INVESTIGATOR
References: