The SABRE Trial: A Single-arm Prospective Study Measuring Safety, Tolerability and Pharmacokinetics of Two SARS-CoV-2 Neutralising Antibodies (C135-LS and C144-LS) Amongst High-risk Special Populations of Vaccine Non-responders.

The SABRE study is a single-arm prospective study measuring safety, tolerability and pharmacokinetics of two SARS-CoV-2 neutralising antibodies (BMS-986414 and BMS-986413) amongst high-risk special populations of vaccine non-responders. The aim is to test the hypothesis that for individuals who fail to mount a measurable immune response to a routinely offered SARS-CoV-2 prophylactic vaccine or for those who are not able to receive such a vaccine (for example those receiving a bone marrow transplant or starting chemotherapy treatment), the receipt of subcutaneous injection of two long-acting neutralising antibodies BMS-986414 and BMS-986413 will confer durable high titres and subsequent immunological protection against SARS-CoV-2 infection.120 eligible participants will be enrolled and followed up for 48 weeks after the one-time dosing visit. Primary inclusion criteria are patients age 18 years and older and either 1) have received two doses of a routine NHS standard of care SARS-Cov-2 vaccine and do not have detectable serum SARS-CoV-2 anti-spike antibodies in routine NHS assays more than two weeks post-vaccination, or do not have protective levels of antibody or 2) be ineligible to receive a SARS-CoV-2 prophylactic vaccine. This could be because they need to commence immediate systemic chemotherapy or receive bone marrow and therefore the requirement to initiate profound immune suppression. Primary objectives are to determine the safety, tolerability and detectable SARS-CoV-2 antibody by specific PPD assay in serum at 12 weeks after enrolment.

开始日期2021-11-29

申办/合作机构

Imperial College Healthcare NHS Trust

[+3]

NCT04518410 / Completed临床2/3期IIT

Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

开始日期2020-08-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+7]

100 项与 BMS-986413 相关的临床结果

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100 项与 BMS-986413 相关的转化医学

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100 项与 BMS-986413 相关的专利（医药）

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项与 BMS-986413 相关的文献（医药）

2024-01-01·Pathogens & immunity

Safety, Efficacy, and Pharmacokinetics of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies BMS-986414 (C135-LS) and BMS-986413 (C144-LS) Administered Subcutaneously in Non-Hospitalized Persons with COVID-19 in a Phase 2 Trial.

Article

作者: Chew, Kara W ; Javan, Arzhang Cyrus ; Li, Jonathan Z ; Mu, Ying ; Smith, Davey M ; Moser, Carlee B ; Hughes, Michael D ; Ritz, Justin ; Fletcher, Courtney V ; Giganti, Mark J ; Wohl, David A ; Corado, Katya C ; Caskey, Marina ; Daar, Eric S ; Eron, Joseph J ; Neytman, Gene ; Currier, Judith S

Background:

Outpatient COVID-19 monoclonal antibody (mAb) treatment via subcutaneous delivery, if eﬀective, overcomes the logistical burdens of intravenous administration.

Methods:

ACTIV-2/A5401 was a randomized, masked placebo-controlled platform trial where participants with COVID-19 at low risk for progression were randomized 1:1 to subcutaneously administered BMS-986414 (C135-LS) 200 mg, plus BMS-986413 (C144-LS) 200 mg, (BMS mAbs), or placebo. Coprimary outcomes were time to symptom improvement through 28 days; nasopharyngeal SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) on days 3, 7, or 14; and treatment-emergent grade 3 or higher adverse events (TEAEs) through 28 days.

Results:

A total of 211 participants (105 BMS mAbs and 106 placebo) initiated study product. Time to symptom improvement favored the active therapy but was not significant (median 8 vs 10 days, P=0.19). There was no significant diﬀerence in the proportion with SARS-CoV-2 RNA

Conclusions:

While safe, the BMS mAbs delivered subcutaneously were not eﬀective at treating COVID-19 at low risk for progression. The lack of clinically significant activity may relate to the pharmacokinetics of subcutaneous administration of mAbs.

100 项与 BMS-986413 相关的药物交易

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