Status:
COMPLETED
Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia
Lead Sponsor:
ImmuneMed, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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.
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2021
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04676971
Start Date
December 11 2020
End Date
October 28 2021
Last Update
December 1 2021
Active Locations (9)
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1
UOC Pneumologia
Bergamo, Italy, 24127
2
Dipartimento di Medicina Interna
Milan, Italy, 20122
3
Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Russia, 660037
4
Central City Hospital of Novoshakhtinsk
Novoshakhtinsk, Russia, 346918