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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: hzVSF-v13; Drug: Placebo (Normal saline solution)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • UOC Pneumologia
  • Milano, Italy, 20122
    • Dipartimento di Medicina Interna
• Russian Federation
  • Krasnoyarsk, Russian Federation, 660037
    • Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
  • Novoshakhtinsk, Russian Federation, 346918
    • Central City Hospital of Novoshakhtinsk
  • Petersburg, Russian Federation, 197706
    • SPb SBIH "Municipal Hospital №40"
  • Petersburg, Russian Federation, 214006
    • Pokrovskaya Municipal Hospita
  • Saratov, Russian Federation, 410053
    • Regional Clinical Hospital
  • Smolensk, Russian Federation, 214006
    • Regional Clinical Hospital No1
  • Ufa, Russian Federation, 450008
    • Federal State Budgetary Educational Institution of Higher Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Age 18 years or older.
3. Patient is currently hospitalized.
4. 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).
5. Able to comply with the study protocol.
6. 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:

1. Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
2. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
3. Anti-rejection or immunomodulatory drugs within the past 3 months.
4. Absolute neutrophil count (ANC) < 1000/µL at screening.
5. Platelet count < 50,000/ µL at screening.
6. ALT or AST > 5 x upper limit of normal (ULN) within 24 hours at screening.
7. Serum creatinine > 2 mg/dL (> 176.8 μmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.
8. Pregnancy or breastfeeding.
9. 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).
10. Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100 mg hzVSF-v13 IV + SOC	Drug: hzVSF-v13; 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); Other Names: a humanized monoclonal antibody (mAb)
Experimental: 200 mg hzVSF-v13 IV + SOC	Drug: hzVSF-v13; 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); Other Names: a humanized monoclonal antibody (mAb)
Placebo Comparator: Placebo (saline) IV + SOC	Drug: Placebo (Normal saline solution); Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7, D14(if necessary); Other Names: 0.9% Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28
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.	Day 28, Day 60
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)	Day 60

Collaborators and Investigators

• Sponsor: ImmuneMed, Inc.
• Investigators: Study Chair: Davide Sonnino, phD, OPIS s.r.l

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): August 29, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: hzVSF_v13-0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No