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Completed

NCT Number: NCT04676971

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UOC Pneumologia, Bergamo, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

Other names: a humanized monoclonal antibody (mAb)

Placebo (Normal saline solution)

Drug

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

Other names: 0.9% Normal saline

Primary outcomes

  1. Clinical failure at Day 28

    Time frame: Day 28

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

ImmuneMed, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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