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

ImmuneMed

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: hzVSF-v13; Drug: Placebo (Normal saline solution)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04676971

hzVSF_v13-0006

Details and patient eligibility

About

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

Full description

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

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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115 participants in 3 patient groups, including a placebo group

100 mg hzVSF-v13 IV + SOC

Experimental group

Description:

100 mg hzVSF-v13 IV + SOC

Treatment:

Drug: hzVSF-v13

200 mg hzVSF-v13 IV + SOC

Experimental group

Description:

200 mg hzVSF-v13 IV + SOC

Treatment:

Drug: hzVSF-v13

Placebo (saline) IV + SOC

Placebo Comparator group

Description:

Placebo (saline) IV + SOC

Treatment:

Drug: Placebo (Normal saline solution)