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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

hzVSF-v13

Placebo (Normal saline solution)

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed written informed consent from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. Note: In accordance with the European Medicines Agency (EMA) "Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic version 3 28/04/2020", if written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent may be given orally by the trial participant in the presence of an impartial witness.
Age 18 years or older.
Patient is currently hospitalized.
Diagnosis of COVID-19 pneumonia including a positive RT-PCR test for SARS-CoV-2 of any specimen and lung involvement confirmed with chest imaging (X-ray or computed tomography [CT] scan).
Able to comply with the study protocol.
Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception throughout the study and for up to 120 days after stopping treatment. Effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.

Exclusion Criteria:

Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
Anti-rejection or immunomodulatory drugs within the past 3 months.
Absolute neutrophil count (ANC) < 1000/µL at screening.
Platelet count < 50,000/ µL at screening.
ALT or AST > 5 x upper limit of normal (ULN) within 24 hours at screening.
Serum creatinine > 2 mg/dL (> 176.8 μmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.
Pregnancy or breastfeeding.
Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational COVID-19 antivirals and other off-label drugs recommended by local health authorities are permitted).
Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).

Sites / Locations

UOC Pneumologia
Dipartimento di Medicina Interna
Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
Central City Hospital of Novoshakhtinsk
SPb SBIH "Municipal Hospital №40"
Pokrovskaya Municipal Hospita
Regional Clinical Hospital
Regional Clinical Hospital No1
Federal State Budgetary Educational Institution of Higher Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

100 mg hzVSF-v13 IV + SOC

200 mg hzVSF-v13 IV + SOC

Placebo (saline) IV + SOC

Arm Description

100 mg hzVSF-v13 IV + SOC

200 mg hzVSF-v13 IV + SOC

Placebo (saline) IV + SOC

Outcomes

Primary Outcome Measures

Clinical failure at Day 28

A patient will be considered a clinical failure if on Day 28 the patient is dead, intubated and/or in ICU.

Secondary Outcome Measures

Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale

Clinical improvement is defined as a decrease of at least two points on the WHO ordinal scale from the Day 1 visit to the Day 28 visit.

Rate of overall survival (OS) at Day 28 and Day 60

Overall survival (OS), defined as the time from randomization to the date of death due to any cause, will be analysed by means of Kaplan-Meier methodology.

Incidence and severity of adverse events according to NCI CTCAE v5.0

The incidence of AEs will be tabulated by MedDRA System Organ Class and Preferred Term. The incidence of AEs will also be summarised by System Organ Class, Preferred Term, and severity (based on NCI CTCAE v5.0 grades)

Full Information

NCT ID

NCT04676971

First Posted

December 16, 2020

Last Updated

November 29, 2021

Sponsor

ImmuneMed, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04676971

Brief Title

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

Official Title

Efficacy and Safety of Intravenously Administered hzVSF-v13 in Patients With COVID-19 Pneumonia: a Phase II, Proof of Concept, Multicentre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

December 11, 2020 (Actual)

Primary Completion Date

August 29, 2021 (Actual)

Study Completion Date

October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ImmuneMed, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.

Detailed Description

Proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100 mg hzVSF-v13 IV + SOC

Arm Type

Experimental

Arm Description

100 mg hzVSF-v13 IV + SOC

Arm Title

200 mg hzVSF-v13 IV + SOC

Arm Type

Experimental

Arm Description

200 mg hzVSF-v13 IV + SOC

Arm Title

Placebo (saline) IV + SOC

Arm Type

Placebo Comparator

Arm Description

Placebo (saline) IV + SOC

Intervention Type

Drug

Intervention Name(s)

hzVSF-v13

Other Intervention Name(s)

a humanized monoclonal antibody (mAb)

Intervention Description

Dosage form: 100mg / 200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1, 3, 7, D14(if necessary)

Intervention Type

Drug

Intervention Name(s)

Placebo (Normal saline solution)

Other Intervention Name(s)

0.9% Normal saline

Intervention Description

Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7, D14(if necessary)

Primary Outcome Measure Information:

Title

Clinical failure at Day 28

Description

A patient will be considered a clinical failure if on Day 28 the patient is dead, intubated and/or in ICU.

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale

Description

Clinical improvement is defined as a decrease of at least two points on the WHO ordinal scale from the Day 1 visit to the Day 28 visit.

Time Frame

Day 28

Title

Rate of overall survival (OS) at Day 28 and Day 60

Description

Overall survival (OS), defined as the time from randomization to the date of death due to any cause, will be analysed by means of Kaplan-Meier methodology.

Time Frame

Day 28, Day 60

Title

Incidence and severity of adverse events according to NCI CTCAE v5.0

Description

Time Frame

Day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed written informed consent from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. Note: In accordance with the European Medicines Agency (EMA) "Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic version 3 28/04/2020", if written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent may be given orally by the trial participant in the presence of an impartial witness. Age 18 years or older. Patient is currently hospitalized. Diagnosis of COVID-19 pneumonia including a positive RT-PCR test for SARS-CoV-2 of any specimen and lung involvement confirmed with chest imaging (X-ray or computed tomography [CT] scan). Able to comply with the study protocol. Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception throughout the study and for up to 120 days after stopping treatment. Effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide. Exclusion Criteria: Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19). Anti-rejection or immunomodulatory drugs within the past 3 months. Absolute neutrophil count (ANC) < 1000/µL at screening. Platelet count < 50,000/ µL at screening. ALT or AST > 5 x upper limit of normal (ULN) within 24 hours at screening. Serum creatinine > 2 mg/dL (> 176.8 μmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation. Pregnancy or breastfeeding. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational COVID-19 antivirals and other off-label drugs recommended by local health authorities are permitted). Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Davide Sonnino, phD

Organizational Affiliation

OPIS s.r.l

Official's Role

Study Chair

Facility Information:

Facility Name

UOC Pneumologia

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Dipartimento di Medicina Interna

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency

City

Krasnoyarsk

ZIP/Postal Code

660037

Country

Russian Federation

Facility Name

Central City Hospital of Novoshakhtinsk

City

Novoshakhtinsk

ZIP/Postal Code

346918

Country

Russian Federation

Facility Name

SPb SBIH "Municipal Hospital №40"

City

Petersburg

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Pokrovskaya Municipal Hospita

City

Petersburg

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

Regional Clinical Hospital

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Regional Clinical Hospital No1

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

Federal State Budgetary Educational Institution of Higher Education

City

Ufa

ZIP/Postal Code

450008

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

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

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