Trial | NCT04676971  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    hzVSF-v13 ...

  • Study Participants

    115
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.
Proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled
Study Started
Dec 11
2020
Primary Completion
Aug 29
2021
Study Completion
Oct 28
2021
Last Update
Dec 01
2021

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)

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

100 mg hzVSF-v13 IV + SOC Experimental

100 mg hzVSF-v13 IV + SOC

200 mg hzVSF-v13 IV + SOC Experimental

200 mg hzVSF-v13 IV + SOC

Placebo (saline) IV + SOC Placebo Comparator

Placebo (saline) IV + SOC

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).
No Results Posted