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

NCT ID: NCT04676971

Last Updated: 2021-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2021-10-28

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.

Detailed Description

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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

100 mg hzVSF-v13 IV + SOC

100 mg hzVSF-v13 IV + SOC

Group Type: EXPERIMENTAL

hzVSF-v13

Intervention Type: 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)

200 mg hzVSF-v13 IV + SOC

200 mg hzVSF-v13 IV + SOC

Group Type: EXPERIMENTAL

hzVSF-v13

Intervention Type: 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)

Placebo (saline) IV + SOC

Placebo (saline) IV + SOC

Group Type: PLACEBO_COMPARATOR

Placebo (Normal saline solution)

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Placebo (Normal saline solution)

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

Intervention Type: DRUG

Other Intervention Names

a humanized monoclonal antibody (mAb); 0.9% Normal saline

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneMed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davide Sonnino, phD

Role: STUDY_CHAIR

OPIS s.r.l

Locations

UOC Pneumologia

Bergamo, , Italy

Dipartimento di Medicina Interna

Milan, , Italy

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

Krasnoyarsk, , Russia

Central City Hospital of Novoshakhtinsk

Novoshakhtinsk, , Russia

SPb SBIH "Municipal Hospital №40"

Saint Petersburg, , Russia

Pokrovskaya Municipal Hospita

Saint Petersburg, , Russia

Regional Clinical Hospital

Saratov, , Russia

Regional Clinical Hospital No1

Smolensk, , Russia

Federal State Budgetary Educational Institution of Higher Education

Ufa, , Russia

Countries

Italy; Russia

Other Identifiers

hzVSF_v13-0006

Identifier Type: -

Identifier Source: org_study_id