Moderate-to-severe COVID-19 pneumonia MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: hzVSF-v13
Product Code: [hzVSF-v13]
Pharmaceutical Form: Solution for infusion
Current Sponsor code: hzVSF-v13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
ImmuneMed Inc.
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
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) 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety endpoints - Incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. - Change from baseline in vital signs and clinical laboratory test results. Efficacy endpoints - Clinical failure at Day 28, defined as any of: • Death • Respiratory failure (patient is intubated) • Patient is in ICU - Clinical Improvement, defined as a decrease of at least 2 points on the WHO ordinal scale: 0. Uninfected: no clinical or virologic evidence of infection 1. Ambulatory: no limitation of activities 2. Ambulatory: limitation of activities 3. Hospitalized with mild disease: no oxygen therapy 4. Hospitalized with mild disease: oxygen by mask or nasal prongs 5. Hospitalized with severe disease: non-invasive ventilation or high-flow oxygen 6. Hospitalized with severe disease: intubation and mechanical ventilation 7. Hospitalized with severe disease: ventilation + additional organ support: vasopressors, renal replacement therapy, extracorporeal membrane oxygenation 8. Death - Time to clinical improvement, defined as the time from randomization to clinical improvement as described above. - Rate of overall survival at Day 28 and Day 60. - Cumulative mortality rate at Days 7, 14, 21, 28, and 60. - Time to hospital discharge or “ready for discharge” (i.e. normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or = 2L supplemental oxygen). Pharmacodynamic endpoint Serum tumour necrosis factor (TNF)-a, interleukin (IL)-1ß, IL-6 and C-reactive protein (CRP) levels at baseline and at specified times after initiation of study drug. If available, the same assessments are to be performed in BAL samples.;Main Objective: - To preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia. - To characterize the pharmacodynamic effects of the hzVSF-v13 doses.;Secondary Objective: - | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Ventilator-free days to Day 28. - Organ failure-free days to Day 28. - Duration of supplemental oxygen. - SARS-CoV-2 viral clearance over time through nasopharyngeal swab and bronchoalveolar lavage (BAL) samples (if available).;Timepoint(s) of evaluation of this end point: - Day 28 - Day 28 - Up to day 60 - Up to day 28 | — |
Countries
Italy, Russian Federation
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed