Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia

NCT04679415 | Completed Phase 2

• 1 other identifier: hzVSF_v13-0007
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical failure rate at Day 28

  The clinical failure rate is defined at Day 28 if patient reported any of * Death * Respiratory failure (patient is intubated) * Patient is in the Intensive Care Unit (ICU)

  Day 28

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

• Time to Clinical Improvement from randomization to clinical improvement (2 points decreased from the baseline score) (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, and Day 28

Study Arms (3)

Standard of care + hzVSF-v13 200 mg at D1, hzVSF-v13 100mg at D3 and D7 IV

EXPERIMENTAL

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)

Drug: hzVSF-v13

Standard of care + hzVSF-v13 400 mg at D1, hzVSF-v13 200mg at D3 and D7 IV

EXPERIMENTAL

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)

Drug: hzVSF-v13

Standard of care + 3 doses of the placebo (normal saline) IV

PLACEBO COMPARATOR

Drug: Placebo (Normal saline solution) Dosage form: 0.9% NaCl Solution Frequency Frequency: Dose at Day 1, 3, 7 Other names: 0.9% Normal saline

Drug: Placebo (Normal saline solution)

Interventions

hzVSF-v13 DRUG

Dosage form: hzVSF-v13 40 mg/mL in a 5 mL vial Frequency: Dose at Day 1, 3, 7

Also known as: a humanized monoclonal antibody (mAb)

Standard of care + hzVSF-v13 200 mg at D1, hzVSF-v13 100mg at D3 and D7 IV; Standard of care + hzVSF-v13 400 mg at D1, hzVSF-v13 200mg at D3 and D7 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 (normal saline) IV

Eligibility Criteria

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

You may qualify if:

• Adults aged at least 18 years at screening
• 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
• 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% (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)
• 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.)
• 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 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.
• Those who are scheduled to have organ transplantation
• 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
• Those who have a positive result for serology (hepatitis B, human immunodeficiency virus \[HIV\], and hepatitis C tests) at screening
• Those who received other investigational products within 30 days prior to the screening visit
• 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

Sponsors & Collaborators

• ImmuneMed, Inc.: lead

Study Sites (3)

Rumah Sakit Pusat Pertamina (include RSPP Extension Simprug)

Jakarta, Jakarta Special Capital Region, 12120, Indonesia

Location

Rumah Sakit Pasar Minggu

Jakarta, Jakarta Special Capital Region, 12550, Indonesia

Location

Rumah Sakit Umum Persahabatan

Jakarta, Jakarta Special Capital Region, 13230, Indonesia

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 Officials

• Prasenohadi Prasenohadi, phD

  Rumah Sakit Umum Persahabatan

  PRINCIPAL INVESTIGATOR

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: December 17, 2020
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)