A Phase 1, Open-Label, Randomized Study to Evaluate Safety and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) Administered Through Intramuscular, Subcutaneous or Intravenous Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults

The primary objectives of this open-label trial were to evaluate the safety and pharmacokinetics (PK) of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) administered intramuscularly (IM), subcutaneously (SC), or intravenously (IV) as a single dose in healthy adults 18-59 years of age with body mass index ≤35 kg/m^2. Prior studies examined IV administration, and the secondary objective of the present study was to compare PK among the three administration routes. No placebo group was included in the phase 1 randomized design. The exploratory objective was to evaluate disease severity in participants that became positive for SARS-CoV-2.

开始日期2021-12-07

申办/合作机构

Emergent BioSolutions, Inc.

[+1]

NCT04661839 / Completed临床1期

A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate Safety and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) Investigational Product (COVID-HIGIV) Administered as a Single Dose Regimen to Healthy Adults

This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.

开始日期2020-12-24

申办/合作机构

Emergent BioSolutions, Inc.

[+1]

JPRN-jRCT1080224100 / Completed临床3期

Multi-center prospective trial of NP028 for patients with peripheral artery disease

开始日期2018-11-16

申办/合作机构

Nipro Corp.

100 项与 Covid-HIGIV 相关的临床结果

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100 项与 Covid-HIGIV 相关的专利（医药）

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项与 Covid-HIGIV 相关的文献（医药）

2022-05-01·Advanced Science1区 · 材料科学

Potent Anti‐SARS‐CoV‐2 Efficacy of COVID‐19 Hyperimmune Globulin from Vaccine‐Immunized Plasma

1区 · 材料科学

ArticleOA

作者: Liu, Ya‐Jie ; Feng, Lu ; Guan, Li‐Dong ; Peng, Yan ; Wang, Man‐Li ; He, Yan‐Lin ; Xie, Yong ; Deng, Kun ; Li, Tao‐Jing ; Yu, Jian‐Hong ; Huang, Wei‐Jin ; Xing, Yan‐Tao ; Hou, Ji‐Feng ; Yu, Ding ; Li, Ce‐Sheng ; Zhou, Dong‐Bo ; Wang, Fei‐Fei ; Du, Tao ; Zhou, Rong ; Ke, Chang‐Wen ; Dong, De‐Mei ; Yang, Hui‐Chuan ; Li, Yu‐Feng ; Zhang, Yong ; Ding, Ya‐Ling ; Liang, Hong ; Li, Chun‐Yan ; Ji, De‐Ming ; Yang, Xiao‐Ming ; Hu, Yong ; Wu, Jun‐Zheng ; Zhou, Zhi‐Jun ; Han, Ren ; Xia, Dong‐Mei ; Liu, Jia ; Liang, Xiao‐Long ; Jia, Rui ; Hu, Heng‐Rui ; Fu, Dao‐Xing

AbstractCoronavirus disease 2019 (COVID‐19) remains a global public health threat. Hence, more effective and specific antivirals are urgently needed. Here, COVID‐19 hyperimmune globulin (COVID‐HIG), a passive immunotherapy, is prepared from the plasma of healthy donors vaccinated with BBIBP‐CorV (Sinopharm COVID‐19 vaccine). COVID‐HIG shows high‐affinity binding to severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) spike (S) protein, the receptor‐binding domain (RBD), the N‐terminal domain of the S protein, and the nucleocapsid protein; and blocks RBD binding to human angiotensin‐converting enzyme 2 (hACE2). Pseudotyped and authentic virus‐based assays show that COVID‐HIG displays broad‐spectrum neutralization effects on a wide variety of SARS‐CoV‐2 variants, including D614G, Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Kappa (B.1.617.1), Delta (B.1.617.2), and Omicron (B.1.1.529) in vitro. However, a significant reduction in the neutralization titer is detected against Beta, Delta, and Omicron variants. Additionally, assessments of the prophylactic and treatment efficacy of COVID‐HIG in an Adv5‐hACE2‐transduced IFNAR−/− mouse model of SARS‐CoV‐2 infection show significantly reduced weight loss, lung viral loads, and lung pathological injury. Moreover, COVID‐HIG exhibits neutralization potency similar to that of anti‐SARS‐CoV‐2 hyperimmune globulin from pooled convalescent plasma. Overall, the results demonstrate the potential of COVID‐HIG against SARS‐CoV‐2 infection and provide reference for subsequent clinical trials.

2007-05-01·Journal of Food Protection3区 · 农林科学

Prevalence and Enumeration of Escherichia coli O157 in Steers Receiving Various Strains of Lactobacillus-Based Direct-Fed Microbials

3区 · 农林科学

Article

作者: T. P. Stephens ; G. H. Loneragan ; L. M. Chichester ; M. M. Brashears

The objective of this research was to evaluate the effect of daily dietary inclusion of specific strains of Lactobacillus acidophilus on prevalence and concentration of Escherichia coli O157 in harvest-ready feedlot cattle. Five hundred yearling steers were housed in pens of 10 animals each. At arrival, steers were randomly allocated to one of five cohorts. Four of the cohorts were fed various strains and dosages of Lactobacillus-based direct-fed microbials throughout the feeding period. Fecal samples were collected from the rectum of each animal immediately prior to shipment to the abattoir. E. coli O157 was detected using selective enrichment and immunomagnetic separation techniques. For positive samples, E. coli O157 concentration was estimated using a most-probable-number (MPN) technique that included immunomagnetic separation. Prevalence varied among the cohorts (P < 0.01). The prevalence in the controls (26.3%) was greater (P < 0.05) than that in cattle supplemented with L. acidophilus strains NP51, NP28, or NP51-NP35 (13.0, 11.0, and 11.0%, respectively). The greatest E. coli O157 concentration was also observed in the controls (3.2 log MPN/g of feces); this concentration was greater (P < 0.05) than that observed in positive animals receiving NP51, NP28, or NP51-NP35 (0.9, 1.1, 1.7 log MPN/g of feces, respectively). Specific strains of Lactobacillus-based direct-fed microbials effectively reduced the prevalence and concentration of E. coli O157 in harvest-ready cattle, whereas others did not. When using direct-fed microbials to reduce carriage of E. coli O157 in cattle, it is important to select appropriately validated products.

1997-07-01·The Annals of Thoracic Surgery2区 · 医学

Effect of Cardiopulmonary Bypass Perfusion Protocols on Gut Tissue Oxygenation and Blood Flow

2区 · 医学

Article

作者: Robert T. Mathie ; David R. Lawrence ; Bruce E. Keogh ; Christopher W. Bowles ; Sunil K. Ohri ; Kenneth M. Taylor

BACKGROUNDPrevious studies in patients undergoing cardiopulmonary bypass (CPB) have documented gastric mucosal hypoperfusion and hypoxia. This study examines the influence of the CPB protocol on the adequacy of gut blood flow and oxygenation.METHODSTwenty-four patients were prospectively randomized into one of four CPB groups: nonpulsatile hypothermic (NP 28); pulsatile hypothermic (P 28); non-pulsatile normothermic (NP 37); and pulsatile normothermic (P 37). Gastric wall blood flow was assessed using laser Doppler flow measurement and gastric mucosal oxygenation (intramucosal pH), using tonometry.RESULTSAfter 10 minutes of CPB, the NP 28 group had the greatest reduction in gastric wall blood flow (-60.6% +/- 3.8%) compared with baseline (p < 0.05). Thirty minutes into CPB, the P 37 group had less gastric mucosal hypoperfusion (-9.7% +/- 10.3%) than the NP 28 patients (-53.0% +/- 8.6%; p < 0.05). All groups showed a hyperemic response immediately after CPB. No significant differences between the four groups were found for gastric mucosal oxygenation during or after CPB. A progressive decline occurred in this variable during the period 3 to 4 hours after CPB. At this time, total-body oxygen consumption and extraction were at their maximum.CONCLUSIONSThis study found that perfusion protocol can influence mucosal blood flow, but other overriding factors that operate during and after CPB act to cause mucosal hypoxia. These findings, particularly the timing of mucosal hypoxia, may have implications for centers contemplating early extubation or "fast tracking" of patients after CPB.

项与 Covid-HIGIV 相关的新闻（医药）

2023-04-05

·Endpoints

InflaRx plans to launch Covid antibody with five-figure price tag

A day after winning emergency use authorization for its Covid-19 antibody, InflaRx said it has enough supply ready to treat several thousand patients. However, the drug will likely have a five-figure price tag. InflaRx is aiming to make vilobelimab available as soon as possible, CEO Niels Riedemann said in a call with analysts on Wednesday. The drug, to be launched under the name Gohibic, was cleared for use in critically ill adults within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation. That’s a much smaller patient population than Gilead’s antiviral Veklury, which launched at $2,340 per course for developed governments and is now approved for both hospitalized and non-hospitalized patients, Riedemann said. Following talks with payers, the chief executive said Gohibic’s list price will likely be a five-digit figure, “and it will not have a 1 as first figure,” he added. The drug was approved roughly a year after failing a topline readout based on a site-stratified analysis of 28-day all-cause deaths. While the original protocol did not call for site stratification, Riedemann said the company changed the protocol about two weeks before unblinding based on recommendations from regulators. That method led to 61 patients at smaller sites being “factually ignored,” he said. Without site stratification, InflaRx reported that vilobelimab did show a statistically significant reduction in all-cause mortality. InflaRx said it had “encouraging interactions” with the FDA, and announced plans to file an NDA back in July. InflaRx execs said they’re currently in discussions with the FDA about filing for a full approval, but it remains unclear whether that will require further studies. Gohibic targets a protein called complement factor C5a in an effort to rein in the body’s inflammatory response. “I think you’ll see from the authorization that the data that we have is fairly solid, but we haven’t had those discussions yet,” VP and head of regulatory affairs Derval O’Carroll said on the call. When asked whether the company would consider a commercial partner, Riedemann said all options are on the table. “We must be relatively opportunistic as a small biotech company. Again, if the idea is to get the drug to patients ASAP, that would not exclude a partner who can do that faster than we do,” he said.

上市批准申请上市加速审批紧急使用授权

2022-12-01

·BioSpace

CORRECTION: Halberd Team Produces Peer Reviewed Article on Antibody Against Covid-19 Omicron Variant

Reason for correction - to correct percentages from rounded figures to more accurate actual numbers. Boosts effectiveness by 44.4% of commercially available Covid antibody in cocktail JACKSON CENTER, PA / ACCESSWIRE / December 1, 2022 / Halberd Corporation's (OTC-PINK:HALB) Covid research has led to a scientific article titled, "A Novel Plant-Made Monoclonal Antibody Enhances the Synergetic Potency of an Antibody Cocktail Against The SARS-Cov-2 Omicron Variant." The article has been peer reviewed and accepted for publication, but has not yet been published. The paper describes the Halberd sponsored research which resulted in an effective monoclonal antibody which has been shown to improve the potency of a commercially available antibody in a cocktail against the SARS Cov-2 Omicron variant from 65% to 93.9% effectiveness. Dr. Mitchell S. Felder, Halberd's Chief Technology Officer and a board-certified attending neurologist stated, "The ability of our antibody to boost the effectiveness of other antibodies in cocktail against Covid-19 is a significant achievement as witnessed by the acceptance for publication of this peer reviewed article." William A. Hartman, Chairman, President & CEO of Halberd Corporation, added, "Halberd's scientists compared our Covid 19 antibody against six other commercially available antibodies, and Halberd's antibody was the only one of the seven antibodies checked that demonstrated an effectiveness against all strains of Covid-19. That alone demonstrates the superiority of Halberd's research team. Our laboratory experimentation successes to date prove that our extracorporeal (outside the body) treatment of bodily fluids could be the most effective methodology for the treatment of diseases in the future." To get the latest news on Halberd's exciting developments, subscribe by submitting this. ( ) For more information please contact: William A. Hartman w.hartman@halberdcorporation.com support@halberdcorporation.com Twitter:@HalberdC This article has been revised to correct rounding of numbers in the original release. We apologize for any confusion. About Halberd Corporation. Halberd Corporation (OTC-PINK:HALB), is a publicly traded company on the OTC Market, and is in full compliance with OTC Market reporting requirements. Since its restructuring in April of 2020, Halberd has obtained exclusive worldwide rights to three issued patents and has filed 22 related provisional, PCT, or utility patent applications to enhance its value to its stockholders and to attract the interests of potential development partners. Safe Harbor Notice Certain statements contained herein are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). The Company' cautions our readers that statements, and assumptions made in this news release constitute forward-looking statements and makes no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time the statements are made. These statements may address issues that involve significant risks, uncertainties and associated estimates made by management. Actual results could differ materially from current projections or implied results. Halberd Corporation undertakes no obligation to revise these statements following the date of this news release. SOURCE: Halberd Corporation View source version on accesswire.com:

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床1期	美国	Emergent BioSolutions, Inc.	2020-12-24

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed	临床1期	-	28	COVID-HIGIV 100 mg/kg	(製膚鹹網鑰鹽顧廠窪網) = 衊淵廠觸構網積淵憲淵鏇觸醖鑰觸夢簾夢繭願 (築鑰鏇鬱網積鏇艱簾選 ) 更多	-	2023-02-28
				COVID-HIGIV 200 mg/kg	(製膚鹹網鑰鹽顧廠窪網) = 獵觸獵簾積簾製壓壓鹽鏇觸醖鑰觸夢簾夢繭願 (築鑰鏇鬱網積鏇艱簾選 ) 更多
NCT04661839 (CTgov)	临床1期	新型冠状病毒感染	28	COVID-HIGIV (COVID-HIGIV Dose Level 1 (100 mg/kg))	夢廠選積鹽夢衊積夢襯(觸構鹽廠鹹鹽觸鬱觸鑰) = 壓構艱範繭襯鑰夢鬱艱鹹築簾廠壓齋艱築獵積 (鑰鹽遞鏇艱襯範選夢膚, 窪鹽艱積壓襯糧簾壓齋 ~ 鏇襯膚廠鬱壓夢齋窪網) 更多	-	2023-02-02
				COVID-HIGIV (COVID-HIGIV Dose Level 2 (200 mg/kg))	夢廠選積鹽夢衊積夢襯(觸構鹽廠鹹鹽觸鬱觸鑰) = 構獵蓋範淵醖壓蓋餘窪鹹築簾廠壓齋艱築獵積 (鑰鹽遞鏇艱襯範選夢膚, 願窪壓窪鏇醖範簾餘窪 ~ 獵廠築鬱廠廠鹽蓋淵壓) 更多