A Stage 2/3, Adaptive, Randomized, Controlled, Double-blind Study to Investigate the Pharmacokinetics, Efficacy and Safety of the Hyperimmune Equine Serum (INM005) in Adult Patients With Moderate to Severe Confirmed SARS-CoV2 Disease.

This study aims to analyze the efficacy and safety of passive immunotherapy by administering an equine hyperimmune serum (INM005) against the SARS-CoV2 RBD to Covid19 patients. Improvement of the clinical course 28 days after the start of treatment will be evaluated.

开始日期2020-07-27

申办/合作机构

Inmunova SA

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项与 INM-005 相关的文献（医药）

2021-04-01·EClinicalMedicine

RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial

Article

作者: Bertetti, Anselmo ; Muñoz, Luciana ; Abusamra, Lorena ; Lopardo, Gustavo ; Kilstein, Yael ; Barcelona, Laura ; Colonna, Mariana ; Lebersztein, Gabriel ; Nannini, Esteban ; Dobarro, Martín ; Stanek, Vanina ; Cahn, Pedro ; de Miguel, Bernardo ; Pereiro, Ana ; Iacono, Marisa ; Belloso, Waldo H ; Caruso, Diego ; Lloret, Santiago Perez ; Cremona, Alberto ; Cruz, Pablo ; Alzogaray, Maria Fernanda ; Crudo, Favio ; Scublinsky, Darío ; Casas, Marcelo Martín ; Zylberman, Vanesa ; Lambert, Sandra ; Luciardi, Héctor Lucas ; Solari, Rubén ; Farina, Javier ; Vidiella, Gabriela ; Millán, Susana ; Sued, Omar ; Sanguineti, Santiago ; Spatz, Linus ; Teijeiro, Ricardo ; Goldbaum, Fernando

BACKGROUNDpassive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2.METHODSwe conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984).FINDINGSbetween August 1st and October 26th, 2020, a total of 245 patients were enrolled. Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54 years old, 65•1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups on primary endpoint (risk difference [95% IC]: 5•28% [-3•95; 14•50]; p = 0•15). Rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14•2 (± 0•7) days in the INM005 group and 16•3 (± 0•7) days in the placebo group, hazard ratio 1•31 (95% CI 1•0 to 1•74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline antibodies. Overall mortality was 6•9% the INM005 group and 11•4% in the placebo group (risk difference [95% IC]: 0•57 [0•24 to 1•37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported.INTERPRETATIONAlbeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease.

2012-03-01·Critical Care Medicine1区 · 医学

The use of hyperimmune serum for severe influenza infections*

1区 · 医学

Article

作者: Middleton, Deborah ; Rockman, Steven ; Maher, Darryl

BACKGROUND AND PURPOSEAlthough use of hyperimmune serum to treat patients with severe influenza infection, infections resistant to antiviral drugs, or as an interim therapy during a pandemic is frequently proposed, there have been no randomized case-control trials to investigate its efficacy. Reports of the use of hyperimmune serum in human influenza infection are sporadic and studies in animal models are limited.METHODSFerrets exposed to an otherwise lethal dose of highly pathogenic avian influenza H5N1 were used as a model of severe human disease. Hyperimmune serum was administered 24 hrs before virus exposure, during early fever, or at the onset of initial clinical signs of influenza (lethargy, lack of appetite) to reflect clinically relevant intervention points. Animals were monitored for 14 days after challenge and assessed for local and constitutional signs of influenza as measured by survival, weight loss, activity scores, viral shedding, and seroconversion.RESULTSAll animals administered hyperimmune serum homologous to the challenge virus before challenge survived the infection with no significant morbidity. The majority of animals receiving hyperimmune serum after virus exposure and during early fever survived the period of observation but showed significant morbidity and prolonged convalescence. The majority of animals that received serum later in the disease course died of acute infection.CONCLUSIONIn highly pathogenic systemic influenza infections, the window for successful intervention by administration of hyperimmune serum may be narrow.

2005-12-01·Acta Pharmacologica Sinica1区 · 医学

Preparation and development of equine hyperimmune globulin F(ab')2 against severe acute respiratory syndrome coronavirus1

1区 · 医学

Article

作者: Han, Wen-yu ; Wong, Bing L. ; Lu, Jia-hai ; Yang, Qin-he ; Guo, Zhong-min ; Zheng, Huan-ying ; Zhang, Ding-mei ; Wang, Guo-ling ; Sun, Sheng-yun ; Wang, Yi-fei ; Zhong, Nan-shan

AIMThe resurgence of severe acute respiratory syndrome (SARS) is still a threat because the causative agent remaining in animal reservoirs is not fully understood, and sporadic cases continue to be reported. Developing high titers of anti-SARS hyperimmune globulin to provide an alternative pathway for emergent future prevention and treatment of SARS.METHODSSARS coronavirus (CoV)F69 (AY313906) and Z2-Y3 (AY394989) were isolated and identified from 2 different Cantonese onset SARS patients. Immunogen was prepared from SARS-CoV F69 strain. Six health horses were immunized 4 times and serum was collected periodically to measure the profile of specific IgG and neutralizing antibodies using indirect enzyme-linked immunosorbent assay and a microneutralization test. Sera were collected in large amounts at the peak, where IgG was precipitated using ammonium sulphate and subsequently digested with pepsin. The product was then purified using anion-exchange chromatography to obtain F(ab')2 fragments.RESULTSThe specific IgG and neutralizing antibody titers peaked at approximately week 7 after the first immunization, with a maximum value of 1:14210. The sera collected at the peak were then purified. Fragment of approximately 15 g F(ab')2 was obtained from 1litre antiserum and the purity was above 90% with the titer of 1:5120, which could neutralize the other strain (SARS-CoV Z2-Y3) as well.CONCLUSIONThis research provides a viable strategy for the prevention and treatment of SARS coronavirus infection with equine hyperimmune globulin, with the purpose of combating any resurgence of SARS.

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研发状态

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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3期	阿根廷	Inmunova SA	2020-07-27

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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


NCT04494984 (Pubmed) 人工标引	临床2/3期	新型冠状病毒感染	241	INM005	構積夢廠艱遞蓋積膚糧(夢艱簾顧窪鬱範範鹽築) = 選壓範願願選鹽製糧艱鬱簾艱築繭艱構壓餘壓 (獵糧鬱憲網淵憲鬱糧範, 0.7) 更多	不佳	2021-04-01
				Placebo	構積夢廠艱遞蓋積膚糧(夢艱簾顧窪鬱範範鹽築) = 簾鹽範鑰夢鑰繭鹹蓋廠鬱簾艱築繭艱構壓餘壓 (獵糧鬱憲網淵憲鬱糧範, 0.7) 更多