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

NCT04676971 | Completed Phase 2

• 1 other identifier: hzVSF_v13-0006
• Study Type: interventional
• Target: 115
• Locations: 2 countries
• Sites: 9

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Day 28

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

  Day 28, Day 60

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

  Day 60

Study Arms (3)

100 mg hzVSF-v13 IV + SOC

EXPERIMENTAL

100 mg hzVSF-v13 IV + SOC

Drug: hzVSF-v13

200 mg hzVSF-v13 IV + SOC

EXPERIMENTAL

200 mg hzVSF-v13 IV + SOC

Drug: hzVSF-v13

Placebo (saline) IV + SOC

PLACEBO COMPARATOR

Placebo (saline) IV + SOC

Drug: Placebo (Normal saline solution)

Interventions

hzVSF-v13 DRUG

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)

Also known as: a humanized monoclonal antibody (mAb)

100 mg hzVSF-v13 IV + SOC; 200 mg hzVSF-v13 IV + SOC

Placebo (Normal saline solution) DRUG

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

Also known as: 0.9% Normal saline

Placebo (saline) IV + SOC

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ImmuneMed, Inc.: lead

Study Sites (9)

UOC Pneumologia

Bergamo, 24127, Italy

Location

Dipartimento di Medicina Interna

Milan, 20122, Italy

Location

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

Krasnoyarsk, 660037, Russia

Location

Central City Hospital of Novoshakhtinsk

Novoshakhtinsk, 346918, Russia

Location

SPb SBIH "Municipal Hospital №40"

Saint Petersburg, 197706, Russia

Location

Pokrovskaya Municipal Hospita

Saint Petersburg, 214006, Russia

Location

Regional Clinical Hospital

Saratov, 410053, Russia

Location

Regional Clinical Hospital No1

Smolensk, 214006, Russia

Location

Federal State Budgetary Educational Institution of Higher Education

Ufa, 450008, Russia

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

• Davide Sonnino, phD

  OPIS s.r.l

  STUDY CHAIR

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 16, 2020
• First Posted: December 21, 2020
• Study Start: December 11, 2020
• Primary Completion: August 29, 2021
• Study Completion: October 28, 2021
• Last Updated: December 1, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); RU (7)