COVID-19Phase 2NCT04676971
Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia
A Phase 2 study testing hzVSF-v13 in people with COVID-19, run by ImmuneMed, Inc. at 9 sites in 2 countries.
Trial summary
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- hzVSF-v13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 11 Dec 2020to 28 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age 18 years or older.
- Patient is currently hospitalized.
- 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).
- Able to comply with the study protocol.
- 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.
Who cannot join
- Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
- Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- Anti-rejection or immunomodulatory drugs within the past 3 months.
- Absolute neutrophil count (ANC) < 1000/µL at screening.
- Platelet count < 50,000/ µL at screening.
- ALT or AST > 5 x upper limit of normal (ULN) within 24 hours at screening.
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- Serum creatinine > 2 mg/dL (> 176.8 μmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.
- Pregnancy or breastfeeding.
- 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).
- Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Russia7 sites
Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, 660037
Central City Hospital of Novoshakhtinsk
Novoshakhtinsk, 346918
SPb SBIH "Municipal Hospital №40"
Saint Petersburg, 197706
Pokrovskaya Municipal Hospita
Saint Petersburg, 214006
Regional Clinical Hospital
Saratov, 410053
Regional Clinical Hospital No1
Smolensk, 214006
Federal State Budgetary Educational Institution of Higher Education
Ufa, 450008
Italy2 sites
UOC Pneumologia
Bergamo, 24127
Dipartimento di Medicina Interna
Milan, 20122
About this study
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
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.
Read the detailed description
Proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled
- Conditions
- COVID-19
- Being tested
- hzVSF-v13, Placebo (Normal saline solution)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hzVSF-v13Drug
Also called a humanized monoclonal antibody (mAb)
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)
Placebo (Normal saline solution)Drug
Also called 0.9% Normal saline
Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7, D14(if necessary)
| Study group | Role | What they receive |
|---|---|---|
| 100 mg hzVSF-v13 IV + SOC | Experimental | 100 mg hzVSF-v13 IV + SOC Receives: Drug: hzVSF-v13 |
| 200 mg hzVSF-v13 IV + SOC | Experimental | 200 mg hzVSF-v13 IV + SOC Receives: Drug: hzVSF-v13 |
| Placebo (saline) IV + SOC | Placebo comparator | Placebo (saline) IV + SOC Receives: Drug: Placebo (Normal saline solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical failure at Day 28
A patient will be considered a clinical failure if on Day 28 the patient is dead, intubated and/or in ICU.
Measured: Day 28
Secondary outcomes (3)
Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale
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.
Measured: Day 28
Rate of overall survival (OS) at Day 28 and 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.
Measured: Day 28, Day 60
Incidence and severity of adverse events according to NCI CTCAE v5.0
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)
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start11 Dec 2020
- Primary completion29 Aug 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmuneMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davide Sonnino, phD, Study chair, OPIS s.r.l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676971
- Sponsor's protocol ID
- hzVSF_v13-0006
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04676971
- Acronym / sponsor ID
- hzVSF_v13-0006
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- ImmuneMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100 mg hzVSF-v13 IV + SOC | Experimental | Drug: hzVSF-v13100 mg hzVSF-v13 IV + SOC |
| 200 mg hzVSF-v13 IV + SOC | Experimental | Drug: hzVSF-v13200 mg hzVSF-v13 IV + SOC |
| Placebo (saline) IV + SOC | Placebo comparator | Drug: Placebo (Normal saline solution)Placebo (saline) IV + SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Age 18 years or older.
- Patient is currently hospitalized.
- 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).
- Able to comply with the study protocol.
Key exclusion criteria (10 listed)
- Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
- Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- Anti-rejection or immunomodulatory drugs within the past 3 months.
- Absolute neutrophil count (ANC) < 1000/µL at screening.
- Platelet count < 50,000/ µL at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hzVSF-v13Also: a humanized monoclonal antibody (mAb)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) | Drug | 100 mg hzVSF-v13 IV + SOC, 200 mg hzVSF-v13 IV + SOC |
| Placebo (Normal saline solution)Also: 0.9% Normal salineDosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7, D14(if necessary) | Drug | Placebo (saline) IV + SOC |
Primary outcome
Clinical failure at Day 28
Time frame: Day 28
A patient will be considered a clinical failure if on Day 28 the patient is dead, intubated and/or in ICU.
3 secondary outcomes
Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale
Time frame: Day 28
Rate of overall survival (OS) at Day 28 and Day 60
Time frame: Day 28, Day 60
Incidence and severity of adverse events according to NCI CTCAE v5.0
Time frame: Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Sonnino, phD study chair
OPIS s.r.l
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hzVSF-v13 in people with COVID-19, run by ImmuneMed, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical failure at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.