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COMPLETEDPHASE2

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

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

NCT04679415•ImmuneMed, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (3)

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

Key Dates

Start Date

December 17, 2020

Primary Completion Date

August 19, 2021

Completion Date

August 19, 2021

Last Updated

February 15, 2024

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

hzVSF-v13

DRUG

Placebo (Normal saline solution)

DRUG

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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