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
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 Name: 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 Name: 0.9% Normal saline
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).
UOC Pneumologia
Bergamo, Italy
Dipartimento di Medicina Interna
Milano, Italy
Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Russian Federation
Central City Hospital of Novoshakhtinsk
Novoshakhtinsk, Russian Federation
SPb SBIH "Municipal Hospital №40"
Petersburg, Russian Federation
Pokrovskaya Municipal Hospita
Petersburg, Russian Federation
Regional Clinical Hospital
Saratov, Russian Federation
Regional Clinical Hospital No1
Smolensk, Russian Federation
Federal State Budgetary Educational Institution of Higher Education
Ufa, Russian Federation
Davide Sonnino, phD, Study Chair
OPIS s.r.l