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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: hzVSF-v13; Drug: Placebo (Normal saline solution)

• Registration Number: NCT04676971
• Lead Sponsor: ImmuneMed, Inc.

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

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-11
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-21
• Primary Completion: 2021-08-29
• Study Completion: 2021-10-28
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
200 mg hzVSF-v13 IV + SOC	hzVSF-v13	200 mg hzVSF-v13 IV + SOC
Placebo (saline) IV + SOC	Placebo (Normal saline solution)	Placebo (saline) IV + SOC
100 mg hzVSF-v13 IV + SOC	hzVSF-v13	100 mg hzVSF-v13 IV + SOC

Primary Outcome Measures

Name	Time	Method
Clinical failure at Day 28	Day 28	A patient will be considered a clinical failure if on Day 28 the patient is dead, intubated and/or in ICU.

Secondary Outcome Measures

Name	Time	Method
Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale	Day 28	Clinical improvement is defined as a decrease of at least two points on the WHO ordinal scale from the Day 1 visit to the Day 28 visit.
Rate of overall survival (OS) at Day 28 and Day 60	Day 28, Day 60	Overall survival (OS), defined as the time from randomization to the date of death due to any cause, will be analysed by means of Kaplan-Meier methodology.
Incidence and severity of adverse events according to NCI CTCAE v5.0	Day 60	The incidence of AEs will be tabulated by MedDRA System Organ Class and Preferred Term. The incidence of AEs will also be summarised by System Organ Class, Preferred Term, and severity (based on NCI CTCAE v5.0 grades)

Trial Locations

Locations (9)

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

Regional Clinical Hospital; 🇷🇺 Saratov, Russian Federation

Regional Clinical Hospital No1; 🇷🇺 Smolensk, Russian Federation

Federal State Budgetary Educational Institution of Higher Education; 🇷🇺 Ufa, Russian Federation

UOC Pneumologia; 🇮🇹 Bergamo, Italy

Pokrovskaya Municipal Hospita; 🇷🇺 Petersburg, Russian Federation

Dipartimento di Medicina Interna; 🇮🇹 Milano, Italy