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Article

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

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Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Persahabatan Hospital, Universitas Indonesia, Jakarta 13230, Indonesia
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Department of Pulmonology, Pasar Minggu General Hospital, South Jakarta 12550, Indonesia
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Department of Pulmonology, Pertamina Pusat Hospital, Jakarta 12120, Indonesia
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clinPHARMA, Precision Medicine & Clinical Trials, Adelaide, SA 5061, Australia
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ImmuneMed, Chuncheon 24232, Korea
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Department of Microbiology, Faculty of Medicine, Hallym University, Chuncheon 24252, Korea
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Head, Infection Prevention & Control—Infectious Disease Service, Foundation University Hospital, Campus Bio-Medico UniCampus University, 00128 Rome, Italy
*
Author to whom correspondence should be addressed.
Academic Editor: Jan Jelrik Oosterheert
J. Clin. Med. 2022, 11(11), 2961; https://doi.org/10.3390/jcm11112961
Received: 15 April 2022 / Revised: 16 May 2022 / Accepted: 20 May 2022 / Published: 24 May 2022
(This article belongs to the Section Infectious Diseases)
Humanized Virus Suppressing Factor-variant 13 (hzVSF-v13), a monoclonal IgG4 antibody against vimentin, was investigated in moderate to severe COVID-19 pneumonia through a Phase II study. Patients were randomized to two different IV doses of the test drug or saline with standard of care. Overall, 64 patients were recruited, and 62 entered the efficacy assessment in the full analysis set. Primary endpoint: The clinical failure rate at day 28 was 15.8% for placebo, 9.1% for low-dose hzVSF-v13 and 9.5% for high-dose hzVSF-v13 (not significant). A trend toward better efficacy was shown in several secondary endpoints, with statistical significance between low-dose hzVSF-v13 and placebo in terms of the rate of improved patients on the ordinal scale for clinical improvement (OSCI): 90.0% vs. 52.63% (p = 0.0116). In the severe stratum, the results of low-dose hzVSF-v13 vs. placebo were 90.0% and 22.2% for OSCI (p = 0.0092), 9 days and 14 days for time to discontinuation of oxygen therapy (p = 0.0308), 10 days and 15 days for both time to clinical improvement (TTCI) and time to recovery (TTR) and p = 0.0446 for both TTCI and TTR. 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. View Full-Text
Keywords: COVID-19; anti-vimentin antibody; placebo-controlled; phase II study COVID-19; anti-vimentin antibody; placebo-controlled; phase II study
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MDPI and ACS Style

Prasenohadi, P.; Burhan, E.; Dhunny, S.; Suharno, W.; Wabnitz, P.; Kim, Y.-W.; Petrosillo, N. 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. J. Clin. Med. 2022, 11, 2961. https://doi.org/10.3390/jcm11112961

AMA Style

Prasenohadi P, Burhan E, Dhunny S, Suharno W, Wabnitz P, Kim Y-W, Petrosillo N. 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. Journal of Clinical Medicine. 2022; 11(11):2961. https://doi.org/10.3390/jcm11112961

Chicago/Turabian Style

Prasenohadi, Prasenohadi, Erlina Burhan, Sri Dhunny, Wahyuningsih Suharno, Paul Wabnitz, Yoon-Won Kim, and Nicola Petrosillo. 2022. "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" Journal of Clinical Medicine 11, no. 11: 2961. https://doi.org/10.3390/jcm11112961

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