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

NCT ID: NCT04679415

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2021-08-19

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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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)

Group Type: EXPERIMENTAL

hzVSF-v13

Intervention Type: DRUG

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

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

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)

Group Type: EXPERIMENTAL

hzVSF-v13

Intervention Type: DRUG

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

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

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

Group Type: PLACEBO_COMPARATOR

Placebo (Normal saline solution)

Intervention Type: DRUG

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

Interventions

hzVSF-v13

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

Intervention Type: DRUG

Placebo (Normal saline solution)

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

Intervention Type: DRUG

Other Intervention Names

a humanized monoclonal antibody (mAb); 0.9% Normal saline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneMed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prasenohadi Prasenohadi, phD

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Umum Persahabatan

Locations

Rumah Sakit Pusat Pertamina (include RSPP Extension Simprug)

Jakarta, Jakarta Special Capital Region, Indonesia

Rumah Sakit Pasar Minggu

Jakarta, Jakarta Special Capital Region, Indonesia

Rumah Sakit Umum Persahabatan

Jakarta, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

hzVSF_v13-0007

Identifier Type: -

Identifier Source: org_study_id