Clinical trial NCT04676971: Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: ImmuneMed, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: Clinical failure at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale
timeFrame: Day 28
measure: Rate of overall survival (OS) at Day 28 and Day 60
timeFrame: Day 28, Day 60
measure: Incidence and severity of adverse events according to NCI CTCAE v5.0
timeFrame: Day 60
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: UOC Pneumologia
city: Milano
country: Italy
facility: Dipartimento di Medicina Interna
city: Krasnoyarsk
country: Russian Federation
facility: Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
city: Novoshakhtinsk
country: Russian Federation
facility: Central City Hospital of Novoshakhtinsk
city: Petersburg
country: Russian Federation
facility: SPb SBIH "Municipal Hospital №40"
city: Petersburg
country: Russian Federation
facility: Pokrovskaya Municipal Hospita
city: Saratov
country: Russian Federation
facility: Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: Regional Clinical Hospital No1
city: Ufa
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education
Study officials:
affiliation: OPIS s.r.l
name: Davide Sonnino, phD
role: STUDY_CHAIR
References: