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更新于：2025-05-07

Anti-COVID-19 immunoglobulin (Kamada)

更新于：2025-05-07

概要

概要

基本信息

药物类型

免疫球蛋白

别名

AntiCorona (COVID19) IgG Kamada、AntiCorona (COVID19) polyclonal immunoglobulin Kamada、Anticorona (COVID19) hyperimmune polyclonal immunoglobulin Kamada

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靶点-

作用方式

调节剂

作用机制

免疫调节剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

权益机构

Columbia University Irving Medical Center

Kamada Ltd.Kedrion SpA

+ [1]

最高研发阶段药物发现

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

项与 Anti-COVID-19 immunoglobulin (Kamada) 相关的临床试验

NCT04550325

/ Completed临床1/2期

A Phase 1/2 Open Label, Multicenter, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients With Pneumonia

Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia

开始日期2020-08-05

申办/合作机构

Kamada Ltd.

100 项与 Anti-COVID-19 immunoglobulin (Kamada) 相关的临床结果

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100 项与 Anti-COVID-19 immunoglobulin (Kamada) 相关的转化医学

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100 项与 Anti-COVID-19 immunoglobulin (Kamada) 相关的专利（医药）

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190

项与 Anti-COVID-19 immunoglobulin (Kamada) 相关的文献（医药）

2025-03-01·Lupus Science & Medicine

Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjögren’s disease: Prepcov multicentre trial

Article

作者: Migueres, Marion ; Lebray, Pascal ; Chauveau, Dominique ; Pugnet, Grégory ; Brusq, Clara ; Cacoub, Patrice ; Bérard, Emilie ; Faure, Stephanie ; Viallard, Jean François ; Alric, Laurent ; Sailler, Laurent

ObjectivesSome patients with SLE or Gougerot-Sjögren’s disease (GSD) receive long-term treatment with hydroxychloroquine (HCQ), sometimes combined with immunosuppressive therapy (IS). This study sought to assess whether long-term HCQ therapy that had been initiated long before the COVID-19 pandemic had a protective or adverse effect on COVID-19 risk, severity of infection or immunity protection.MethodsThis prospective multicentre study included 547 patients with SLE, GSD, autoimmune hepatitis, primary biliary cholangitis or cured viral hepatitis C divided into four groups according to HCQ (+/−) and IS (+/−) intake prior to the pandemic: HCQ+IS+ (n=112), HCQ+IS− (n=121), HCQ−IS+ (n=115) and HCQ−IS− (n=199). When COVID-19 vaccination was possible, patients were vaccinated as recommended. Vaccination efficacy was prospectively assessed on the basis of the postvaccination antibody titre.ResultsCompared with HCQ+IS+ patients, HCQ−IS+ patients had a decreased risk of COVID-19 infection (p<0.001). Compared with HCQ+IS+ patients, HCQ−IS− patients had a decreased risk of contracting COVID-19 (p<0.001). Patients in the HCQ−IS+ or HCQ−IS− group had a lower risk of symptomatic or severe infection than HCQ+IS+ patients did (p=0.001 and p<0.001, respectively). Only patients who had two or more exposures (to vaccine and/or infection) had an increased likelihood of COVID-19 immunity after the last dose (p<0.001).ConclusionsHCQ treatment that was initiated before the pandemic did not protect against COVID-19 infection. Moreover, non-exposure to HCQ treatment (combined or not with IS) was associated with decreased risk of COVID-19 infection and of developing a symptomatic or severe infection. HCQ and IS do not influence the vaccine response. Only two or more doses of vaccine result in a good vaccine response.Trial registration numberNCT04481633.

2025-03-01·Journal of the Formosan Medical Association

Liver injury in non-severe COVID-19 with various pandemic phases: A real-world study

Article

作者: Sethasine, Supatsri ; Winyupakorn, Jirayuth ; Devakul Na Ayutthaya, Watcharaporn ; Sangketchon, Chunlanee

BACKGROUNDCOVID-19 severity affects liver damage. The utilization of various anti-COVID-19 drugs in non-severe cases related to liver impairment in the short term seemed intriguing.OBJECTIVESTo assess the dynamic course of liver injury in mild to moderate COVID-19 patients within 10 days of admission and identify risk variables, including medication linkage.METHODSThis prospective cohort study of 300 newly diagnosed mild to moderate COVID-19 cases between September 2021 and October 2022. Tertiary center hospitel, field hospital, or cohort ward admissions were made. Patient demographics and treatment were recorded. The drug, liver injury (LI) dynamics, and clinical course were evaluated.RESULTSHospitel/field hospital (188) and cohort wards (112) had 300 individuals. One hundred fifteen participants had liver damage. Favipiravir (45 %), remdesivir (17.4 %), molnupiravir (11.3 %), Andrographis paniculata (ADG) (8.7 %), and favipiravir plus ivermectin (7.7 %) were given to most LI group (n = 104). The baseline AST/ALT levels of 68 (65.4 %) treated patients were abnormal. Favipiravir, remdesivir, and favipiravir + ivermectin increased mean AST/ALT in participants with normal baseline AST/ALT (p = 0.001, 0.003, and 0.016, respectively), but not molnupiravir or Andrographis paniculata. Transaminase levels climbed in untreated patients independent of baseline. The ground-glass imaging pattern was linked to mild LI. Most subjects had transaminase declines after 10 days. Preexisting liver disease did not increase the likelihood of in-hospital LI.CONCLUSIONIn the real world, a less-than-critical level of liver damage was reported in mild to moderate COVID-19 that allows clinicians to administer a variety of standard medications during short periods of hospital stay.

2025-01-01·Vaccine: X

Safety and durability of the immune response after vaccination with the heterologous schedule of anti-COVID-19 vaccines SOBERANA®02 and SOBERANA® Plus in children 3–18 years old

Article

作者: Fernández-Castillo, Sonsire ; Pérez-Nicado, Rocmira ; Silva, Carmen Valenzuela ; Valdés-Balbín, Yury ; Puga-Gómez, Rinaldo ; Paredes-Moreno, Beatriz ; Ricardo-Delgado, Yariset ; García-Rivera, Dagmar ; Sánchez-Ramírez, Belinda ; Vérez-Bencomo, Vicente G ; Hernández-García, Tays ; Rodríguez-González, Meiby ; Climent-Ruiz, Yanet ; Santana-Mederos, Darielys ; Martínez-Perez, Marisel ; Cruz-Sui, Otto ; Noa-Romero, Enrique ; García-López, Arilia ; Palenzuela-Diaz, Ariel ; Rodríguez-Noda, Laura

BackgroundThe heterologous three-dose schedule of the protein subunit anti-COVID-19 SOBERANA®02 and SOBERANA® Plus vaccines has proved its safety, immunogenicity and efficacy in pediatric population, but durability of immunogenicity is not yet dilucidated. This study reports the safety and durability of the humoral and cellular responses in children and adolescents 5-7 months after receiving the heterologous vaccine schedule of SOBERANA® 02 and SOBERANA® Plus.MethodsChildren participating in a phase I/II clinical trial were followed-up for 5-7 months after the last dose. They were clinically examined by medical doctors, and their parents were interviewed searching for long-term adverse events. Blood samples were collected to evaluate the duration of humoral and cellular immune responses. Sera were tested for the presence of SARS-CoV-2 nucleocapsid (N) protein.ResultsThere were no reports of severe adverse events such as coagulation disorders, myocarditis, or pericarditis. None of the participants who withdrew from the trial during the follow-up period did so due to post-vaccination adverse events. The humoral response waned in time for N-negative children, but levels of specific and neutralizing antibodies remained similar to those attained after the second dose of SOBERANA® 02 in the heterologous schedule. Neutralizing antibodies against SARS-CoV-2 D614G and omicron BA.1 were detected 5-7 months post-vaccination. RBD-specific IFN-γ secreting cells showed no significant change compared to levels following primary immunization, in both N-negative and N-positive children.ConclusionsThe vaccination regimen was safe over time, and both humoral and cellular immunity persisted in the vaccinated population aged 3-18 years, 5-7 months after receiving the heterologous SOBERANA® 02 and SOBERANA® Plus vaccine schedule.Trial registry: https://rpcec.sld.cu/trials/RPCEC00000374-En.

100 项与 Anti-COVID-19 immunoglobulin (Kamada) 相关的药物交易

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研发状态

10 条进展最快的记录,

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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	临床前	以色列	Kamada Ltd.	2020-08-05
严重急性呼吸综合征	临床前	以色列	Kamada Ltd.	2020-08-05
COVID-19 呼吸道感染	药物发现	美国	Kamada Ltd.	-