- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Journal: Viral and symptom rebound following anti-SARS-CoV-2 monoclonal antibody therapy in a randomized placebo-controlled trial. (Pubmed Central) - Feb 4, 2025
Viral rebound was defined as RNA ?3 and ?0.5 log10 copies/mL increase from day 3 or 7, and symptom rebound as hospitalization or any moderate/severe symptom for ?2 days after initial symptom improvement. There was no difference in viral rebound (?5%/arm) (analysis population n=713) or symptom rebound among participants who initially improved (hazard ratio 0.95 (95% CI 0.52, 1.75, analysis population) n=574); <1% had both viral/symptom rebound.
- |||||||||| Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Clinical, Retrospective data, Review, Journal: Sotrovimab in the treatment of coronavirus disease-2019 (COVID-19): a systematic review and meta-analysis of randomized clinical trials. (Pubmed Central) - Nov 21, 2024
The total population consisted of 5470 patients with COVID-19, 1921 (35%) in the sotrovimab group and 3549 (65%) in the control group (placebo or BRII-196?+?BRII-198 or casirivimab?+?imdevimab or bamlanivimab?+?etesevimab, administered in a similar way to sotrovimab, in a single dose with a 60-min intravenous infusion)...The use of sotrovimab in the treatment of patients with COVID-19 had no significant impact on mortality and need for mechanical ventilation and did not appear to be safer compared to controls. However, there was evidence of effectiveness in reducing the rate of hospitalization, although the certainty of the evidence is moderate and the risk of bias is high.
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Retrospective data, Journal: Effect of amubarvimab-romlusevimab for treatment of severe COVID-19 in intensive care units: A retrospective cohort study. (Pubmed Central) - Sep 24, 2024
After including the above covariates, Multifactorial COX regression shows that the Amubarvimab - romlusevimab therapy(HR:0.392; CI:[0.211-0.729]; p:0.003), CRP, Lactate and PT-INR at admission are independent factors for mortality of severe COVID-19. Based on the current data, we conclude that amubarvimab-romlusevimab therapy is beneficial for patients with severe COVID-19.
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Viral and Symptom Rebound After COVID-19 Monoclonal Antibody Therapy in the ACTIV-2 Trial (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_916;
This randomized trial found no significant differences in symptom experiences or viral rebound between mAb- vs placebo-treated participants. With or without treatment, rebound rates were low following sustained symptom improvement or resolution.
- |||||||||| Journal: Impact of BA.1, BA.2, and BA.4/BA.5 Omicron mutations on therapeutic monoclonal antibodies. (Pubmed Central) - Nov 27, 2023
We introduce a mutational escape map for each mAb to identify the key RBD sites and the corresponding critical mutations. Overall, our findings suggest that the majority of therapeutic mAbs have diminished or missing activity against Omicron subvariants, indicating the urgent need for a new therapeutic mAb with a better design.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Trial completion: TICO: ACTIV-3: Therapeutics for Inpatients With COVID-19 (clinicaltrials.gov) - Aug 25, 2023
P3, N=2753, Completed,
Overall, our findings suggest that the majority of therapeutic mAbs have diminished or missing activity against Omicron subvariants, indicating the urgent need for a new therapeutic mAb with a better design. Active, not recruiting --> Completed
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Trial completion: ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - Jul 27, 2023
P2/3, N=4044, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Observational data, Journal: Neutralizing monoclonal antibody in patients with coronavirus disease 2019: an observational study. (Pubmed Central) - Dec 16, 2022
In elderly patients with mild or moderate COVID-19 disease, who do not require oxygen support and had the risk factors for disease progression to severe COVID-19 disease, the administration of BRII-196/198 within 3 The results of this study suggest that the application of BRII-196 and BRII-198 antibody therapy improved clinical status in patients with SARS-CoV-2 delta variant infection.
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Review, Journal: Amubarvimab/Romlusevimab: First Approval. (Pubmed Central) - Sep 29, 2022
An Emergency Use Authorization application for amubarvimab/romlusevimab is currently under review in the USA. This article summarizes the milestones in the development of amubarvimab/romlusevimab leading to this first approval for the treatment of COVID-19.
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
P1 data, PK/PD data, Journal: Randomized, placebo-controlled, single-blind phase 1 studies of the safety, tolerability, and pharmacokinetics of BRII-196 and BRII-198, SARS-CoV-2 spike-targeting monoclonal antibodies with an extended half-life in healthy adults. (Pubmed Central) - Sep 24, 2022
P1
BRII-196 and BRII-198 are safe, well-tolerated, and suitable therapeutic or prophylactic options for SARS-CoV-2 infection. Clinical Trial Registration: ClinicalTrials.gov under identifiers NCT04479631, NCT04479644, and NCT04691180.
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Journal: Listing of the neutralizing antibodies amubarvimab and romlusevimab in China: Hopes and impediments. (Pubmed Central) - Sep 23, 2022
Based on its potential to effectively combat severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its Omicron variant at a modest cost and under medical insurance, this controversial biotherapy is anticipated to be widely available in China. Hopefully, whether and how the proposed medication will alter the treatment of COVID-19 in China will be apparent soon, as well as if it will help to reduce hospitalizations, reduce the incidence of severe illness, or even act as pre-exposure prophylaxis.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Enrollment change: TICO: ACTIV-3: Therapeutics for Inpatients With COVID-19 (clinicaltrials.gov) - Aug 16, 2022
P3, N=2753, Active, not recruiting,
Overall, our findings elucidate the developmental process and maturation pathway of P2C-1F11, providing some important information for the design of novel immunogens to elicit more potent nAbs against SARS-CoV-2 infection. N=10000 --> 2753
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Trial completion date: TICO: ACTIV-3: Therapeutics for Inpatients With COVID-19 (clinicaltrials.gov) - Jul 27, 2022
P3, N=10000, Active, not recruiting,
N=10000 --> 2753 Trial completion date: Jul 2022 --> Jul 2023
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Preclinical, Journal: SARS-CoV-2 Omicron Variants Reduce Antibody Neutralization and Acquire Usage of Mouse ACE2. (Pubmed Central) - Jul 6, 2022
Analyzing ACE2 from diverse host species showed that Omicron variants acquired ability to use mouse ACE2 for entry. These results demonstrate major antigenic shifts and potentially broadening the host range of two major Omicron lineages BA.1/BA.1.1 and BA.2, posing serious challenges to current antibody therapies and vaccine protection as well as increasing danger of spillover into the wildlife.
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Clinical, Journal: Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial. (Pubmed Central) - Apr 27, 2022
P3
These results demonstrate major antigenic shifts and potentially broadening the host range of two major Omicron lineages BA.1/BA.1.1 and BA.2, posing serious challenges to current antibody therapies and vaccine protection as well as increasing danger of spillover into the wildlife. Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - Mar 31, 2022
P2/3, N=4044, Active, not recruiting,
Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19. Recruiting --> Active, not recruiting | N=8797 --> 4044 | Trial completion date: Dec 2023 --> Jun 2023 | Trial primary completion date: Dec 2023 --> Mar 2022
- |||||||||| Review, Journal: Pharmacological treatment of COVID-19: an opinion paper. (Pubmed Central) - Mar 18, 2022
The development of vaccines has not prevented, during the whole period of the pandemic, the constant search for therapeutic medicines, both among existing drugs with different indications and in the development of new drugs. The Scientific Committee of the COVID-19 of the Illustrious College of Physicians of Madrid wanted to offer an early, simplified and critical approach to these new drugs, to new developments in immunotherapy and to what has been learned from the immune response modulators already known and which have proven effective against the virus, in order to help understand the current situation.
- |||||||||| Journal: Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. (Pubmed Central) - Mar 3, 2022
Together, data suggest Omicron would cause significant humoral immune evasion, while NAbs targeting the sarbecovirus conserved region remain most effective. Our results offer instructions for developing NAb drugs and vaccines against Omicron and future variants.
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Trial completion, Enrollment change: A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 (clinicaltrials.gov) - Feb 11, 2022
P1, N=12, Completed,
Our results offer instructions for developing NAb drugs and vaccines against Omicron and future variants. Recruiting --> Completed | N=24 --> 12
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Trial completion, Enrollment change: A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 (clinicaltrials.gov) - Jan 25, 2022
P2, N=48, Completed,
Recruiting --> Completed | N=24 --> 12 Recruiting --> Completed | N=24 --> 48
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, Tsinghua University, amubarvimab (BRII-196) / Tsinghua University, Brii Biosci, Third Peoples Hospital of Shenzhen, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Clinical, Clinical data: Efficacy and safety of two neutralizing MAb therapies, sotrovimab and BRII-196+BRII-198, for adults hospitalised with COVID https://t.co/QtUaUZFe5j. Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID (Twitter) - Jan 10, 2022
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, Tsinghua University, amubarvimab (BRII-196) / Tsinghua University, Brii Biosci, Third Peoples Hospital of Shenzhen, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Sotrovimab activity unchanged, and Amubarvimab / Romlusevimab (BRII-196, BRII-198) activity largely intact against #Omicron https://t.co/hjjMAG49kl But we still need to get antibodies to the right people- Timely, equitably, those without antibodies 4/n (Twitter) - Jan 5, 2022
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Enrollment change, Trial completion date, Trial primary completion date: ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - Aug 23, 2021
P2/3, N=8797, Recruiting,
Future studies should focus on effective immune-therapeutics and immunomodulators with the purpose of developing specific, affordable, and cost-effective prophylactic and treatment regimens to fight the COVID-19 globally. N=2000 --> 8797 | Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023
- |||||||||| romlusevimab (BRII-198) / Brii Biosci, amubarvimab (BRII-196) / Brii Biosci
Enrollment open, Trial initiation date: A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 (clinicaltrials.gov) - Jul 27, 2021
P2, N=24, Recruiting,
N=2000 --> 8797 | Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023 Not yet recruiting --> Recruiting | Initiation date: Mar 2021 --> Jun 2021
- |||||||||| BRII-196 / Tsinghua University, Brii Biosci, Third Peoples Hospital of Shenzhen
Journal: Single-Cell RNA Sequencing Analysis of the Immunometabolic Rewiring and Immunopathogenesis of Coronavirus Disease 2019. (Pubmed Central) - May 15, 2021
Moreover, enhanced glycolysis or OXPHOS was positively associated with the differentiation of memory B cells into plasmablasts or plasma cells. This study comprehensively investigated the metabolic features of peripheral immune cells and revealed that metabolic changes exacerbated inflammation in monocytes and promoted antibody secretion and cell survival in PCs in COVID-19 patients, especially those with severe disease.
- |||||||||| amubarvimab (BRII-196) / Brii Biosci
Trial completion: Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196 (clinicaltrials.gov) - Apr 12, 2021
P1, N=16, Completed,
This study comprehensively investigated the metabolic features of peripheral immune cells and revealed that metabolic changes exacerbated inflammation in monocytes and promoted antibody secretion and cell survival in PCs in COVID-19 patients, especially those with severe disease. Active, not recruiting --> Completed
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Trial completion date, Trial primary completion date: ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - Mar 23, 2021
P2/3, N=2000, Recruiting,
Active, not recruiting --> Completed Trial completion date: Dec 2021 --> May 2023 | Trial primary completion date: Dec 2021 --> May 2023
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Trial completion date, Trial primary completion date: ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - Jan 6, 2021
P2/3, N=2000, Recruiting,
Trial completion date: Dec 2021 --> May 2023 | Trial primary completion date: Dec 2021 --> May 2023 Trial completion date: Feb 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Dec 2021
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Enrollment open, Trial completion date, Trial primary completion date: TICO: ACTIV-3: Therapeutics for Inpatients With COVID-19 (clinicaltrials.gov) - Dec 30, 2020
P3, N=10000, Recruiting,
Trial completion date: Feb 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Dec 2021 Active, not recruiting --> Recruiting | Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Jul 2021 --> Jul 2022
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