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

Sponsor
ImmuneMed, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04676971
Collaborator
(none)
115
Enrollment
9
Locations
3
Arms
10.5
Actual Duration (Months)
12.8
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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.
Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 11, 2020
Actual Primary Completion Date :
Aug 29, 2021
Actual Study Completion Date :
Oct 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 100 mg hzVSF-v13 IV + SOC

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

    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

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical failure at Day 28 [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

    1. Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale [Day 28]

      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.

    2. Rate of overall survival (OS) at Day 28 and Day 60 [Day 28, 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.

    3. Incidence and severity of adverse events according to NCI CTCAE v5.0 [Day 60]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UOC Pneumologia Bergamo Italy 24127
    2 Dipartimento di Medicina Interna Milano Italy 20122
    3 Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency Krasnoyarsk Russian Federation 660037
    4 Central City Hospital of Novoshakhtinsk Novoshakhtinsk Russian Federation 346918
    5 SPb SBIH "Municipal Hospital №40" Petersburg Russian Federation 197706
    6 Pokrovskaya Municipal Hospita Petersburg Russian Federation 214006
    7 Regional Clinical Hospital Saratov Russian Federation 410053
    8 Regional Clinical Hospital No1 Smolensk Russian Federation 214006
    9 Federal State Budgetary Educational Institution of Higher Education Ufa Russian Federation 450008

    Sponsors and Collaborators

    • ImmuneMed, Inc.

    Investigators

    • Study Chair: Davide Sonnino, phD, OPIS s.r.l

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ImmuneMed, Inc.
    ClinicalTrials.gov Identifier:
    NCT04676971
    Other Study ID Numbers:
    • hzVSF_v13-0006
    First Posted:
    Dec 21, 2020
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Pneumonia

    Study Results

    No Results Posted as of Dec 1, 2021