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- |||| burfiralimab (hzVSF(IgG4)) / Immunemed
New P2 trial: A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug) (clinicaltrials.gov) - Mar 11, 2024
P2, N=60, Not yet recruiting, Sponsor: ImmuneMed, Inc.
- | burfiralimab (hzVSF(IgG4)) / Immunemed
Enrollment change, Trial termination: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Feb 15, 2024
P2, N=1, Terminated, Sponsor: ImmuneMed, Inc.
N=48 --> 1 | Recruiting --> Terminated; A new study combining Phase III clinical trials has been planned.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Trial completion: Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration) (clinicaltrials.gov) - Feb 15, 2024
P1, N=72, Completed, Sponsor: ImmuneMed, Inc.
N=48 --> 1 | Recruiting --> Terminated; A new study combining Phase III clinical trials has been planned. Recruiting --> Completed
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug) (clinicaltrials.gov) - Jun 15, 2023
P2a, N=32, Recruiting, Sponsor: ImmuneMed, Inc.
Recruiting --> Completed Active, not recruiting --> Recruiting | N=24 --> 32 | Trial completion date: Sep 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Mar 2024
- || burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
New P2a trial, Combination therapy, Monotherapy: A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug) (clinicaltrials.gov) - Apr 11, 2023
P2a, N=24, Active, not recruiting, Sponsor: ImmuneMed, Inc.
- | hzVSF(IgG4) / Immunemed, Seoul National University Hospital
Journal: Double-Blind, Randomized, Placebo-Controlled Study on hzVSF-v13, a Novel Anti-Vimentin Monoclonal Antibody Drug as Add-on Standard of Care in the Management of Patients with Moderate to Severe COVID-19. (Pubmed Central) - Jun 11, 2022
Change from baseline of NEWS2 score at day 28 was -3.4 vs. + 0.4 (p = 0.0441). The results propose hzVSF-v13 as a candidate in the treatment of severe COVID-19.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Trial completion: Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 1, 2021
P2, N=115, Completed, Sponsor: ImmuneMed, Inc.
The results propose hzVSF-v13 as a candidate in the treatment of severe COVID-19. Recruiting --> Completed
- || burfiralimab (hzVSF(IgG4)) / Immunemed
Enrollment open, Trial completion date, Trial primary completion date: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Aug 25, 2021
P2, N=48, Recruiting, Sponsor: ImmuneMed, Inc.
Recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Nov 2021
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed
Trial completion, Trial completion date, Trial primary completion date: Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Aug 25, 2021
P2, N=63, Completed, Sponsor: ImmuneMed, Inc.
Not yet recruiting --> Recruiting | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Nov 2021 Recruiting --> Completed | Trial completion date: May 2021 --> Aug 2021 | Trial primary completion date: Apr 2021 --> Aug 2021
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Trial completion: Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (clinicaltrials.gov) - Apr 2, 2021
P1, N=56, Completed, Sponsor: ImmuneMed, Inc.
Recruiting --> Completed | Trial completion date: May 2021 --> Aug 2021 | Trial primary completion date: Apr 2021 --> Aug 2021 Enrolling by invitation --> Completed
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
New P1 trial: Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration) (clinicaltrials.gov) - Mar 25, 2021
P1, N=72, Recruiting, Sponsor: ImmuneMed, Inc.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed
Enrollment open: Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Jan 5, 2021
P2, N=63, Recruiting, Sponsor: ImmuneMed, Inc.
Enrolling by invitation --> Completed Not yet recruiting --> Recruiting
- || HzVSFv-13 / Immunemed, Seoul National University Hospital
Clinical, Journal: Compassionate use of hzVSF-v13 in two patients with severe COVID-19. (Pubmed Central) - Dec 31, 2020
Both patients, including an 81-year-old man who required extracorporeal membrane oxygenation, showed clinical improvement. These results warrant placebo-controlled trials to evaluate the hzVSF-v13 efficacy against COVID-19.
- || burfiralimab (hzVSF(IgG4)) / Immunemed
New P2 trial: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 22, 2020
P2, N=48, Not yet recruiting, Sponsor: ImmuneMed, Inc.
- |||| burfiralimab (hzVSF(IgG4)) / Immunemed
New P2 trial: Efficacy and Safety of hzVSF-v13 in Moderate to Severe Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 22, 2020
P2, N=63, Not yet recruiting, Sponsor: ImmuneMed, Inc.
- |||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
New P2 trial: Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - Dec 20, 2020
P2, N=105, Recruiting, Sponsor: ImmuneMed, Inc.
- ||| burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
Enrollment open, Trial primary completion date: Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (clinicaltrials.gov) - Dec 3, 2018
P1, N=56, Enrolling by invitation, Sponsor: ImmuneMed, Inc.
These results warrant placebo-controlled trials to evaluate the hzVSF-v13 efficacy against COVID-19. Not yet recruiting --> Enrolling by invitation | Trial primary completion date: May 2019 --> Aug 2019
- | burfiralimab (hzVSF(IgG4)) / Immunemed, Seoul National University Hospital
New P1 trial: Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (clinicaltrials.gov) - Aug 31, 2018
P1, N=56, Not yet recruiting, Sponsor: ImmuneMed, Inc.