British Journal of Clinical Pharmacology
Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID‐19: A phase 2a, open‐label, single‐dose escalation study
Manon L M Prins
1
,
Johan L Van Der Plas
1, 2
,
Maurits F.J.M. Vissers
2, 3
,
Cécile L Berends
2, 3
,
Gaby Tresch
4
,
Marianne Soergel
4
,
Elena Fernández
4
,
Nikita Van Den Berge
5
,
Daniël Duijsings
6
,
Christof ZITT
4
,
Vaia Stavropoulou
4
,
Maya Zimmermann
4
,
Roxana F Drake
4
,
Jacobus Burggraaf
2, 3
,
Geert H Groeneveld
1
,
Ingrid M. C. Kamerling
1, 2
2
Centre for Human Drug Research Leiden the Netherlands
|
4
Molecular Partners AG Schlieren Switzerland
|
5
Municipal Health Services (GGD Hollands Midden) Leiden The Netherlands
|
6
Viroclinics Biosciences B.V. Rotterdam The Netherlands
|
Publication type: Journal Article
Publication date: 2022-10-24
Quartile SCImago
Q1
Quartile WOS
Q2
Impact factor: 3.4
ISSN: 03065251, 13652125
Pharmacology
Pharmacology (medical)
Abstract
To assess viral clearance, pharmacokinetics, tolerability and symptom evolution following ensovibep administration in symptomatic COVID-19 outpatients.In this open-label, first-in-patient study a single dose of either 225 mg (n = 6) or 600 mg (n = 6) of ensovibep was administered intravenously in outpatients with mild-to-moderate COVID-19 symptoms. Pharmacokinetic profiles were determined (90-day period). Pharmacodynamic assessments consisted of viral load (qPCR and cultures) and symptom questionnaires. Immunogenicity against ensovibep and SARS-CoV-2-neutralizing activity were determined. Safety and tolerability were assessed throughout a 13-week follow-up.Both doses showed similar pharmacokinetics (first-order) with mean half-lives of 14 (SD 5.0) and 13 days (SD 5.7) for the 225- and 600-mg groups, respectively. Pharmacologically relevant serum concentrations were maintained in all subjects for at least 2 weeks postdose, regardless of possible immunogenicity against ensovibep. Viral load changes from baseline at day 15 were 5.1 (SD 0.86) and 5.3 (SD 2.2) log10 copies/mL for the 225- and 600-mg doses, respectively. COVID-19 symptom scores decreased from 10.0 (SD 4.1) and 11.3 (SD 4.0) to 1.6 (SD 3.1) and 3.3 (SD 2.4) in the first week for the 225- and 600-mg groups, respectively. No anti-SARS-CoV-2 neutralizing activity was present predose and all patients had SARS-CoV-2 antibodies at day 91. Adverse events were of mild-to-moderate severity, transient and self-limiting.Single-dose intravenous administration of 225 or 600 mg of ensovibep appeared safe and well tolerated in patients with mild-to-moderate COVID-19. Ensovibep showed favourable pharmacokinetics in patients and the pharmacodynamic results warrant further research in a larger phase 2/3 randomized-controlled trail.
Top-30
Citations by journals
|
1
2
|
|
|
British Journal of Clinical Pharmacology
2 publications, 33.33%
|
|
|
Nature Communications
1 publication, 16.67%
|
|
|
Naunyn-Schmiedeberg's Archives of Pharmacology
1 publication, 16.67%
|
|
|
Open Forum Infectious Diseases
1 publication, 16.67%
|
|
|
Russian Chemical Reviews
1 publication, 16.67%
|
|
|
1
2
|
Citations by publishers
|
1
2
|
|
|
Wiley
2 publications, 33.33%
|
|
|
Springer Nature
2 publications, 33.33%
|
|
|
Oxford University Press
1 publication, 16.67%
|
|
|
Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii
1 publication, 16.67%
|
|
|
1
2
|
- We do not take into account publications without a DOI.
- Statistics recalculated only for publications connected to researchers, organizations and labs registered on the platform.
- Statistics recalculated weekly.
{"yearsCitations":{"type":"bar","data":{"show":true,"labels":[2023,2024],"ids":[0,0],"codes":[0,0],"imageUrls":["",""],"datasets":[{"label":"Citations number","data":[3,3],"backgroundColor":["#3B82F6","#3B82F6"],"percentage":["50","50"],"barThickness":null}]},"options":{"indexAxis":"x","maintainAspectRatio":true,"scales":{"y":{"ticks":{"precision":0,"autoSkip":false,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":false},"x":{"ticks":{"stepSize":1,"precision":0,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":false}},"plugins":{"legend":{"position":"top","labels":{"font":{"family":"Montserrat"},"color":"#000000"}},"title":{"display":true,"text":"Citations per year","font":{"size":24,"family":"Montserrat","weight":600},"color":"#000000"}}}},"journals":{"type":"bar","data":{"show":true,"labels":["British Journal of Clinical Pharmacology","Nature Communications","Naunyn-Schmiedeberg's Archives of Pharmacology","Open Forum Infectious Diseases","Russian Chemical Reviews"],"ids":[5846,3231,5278,14565,23802],"codes":[0,0,0,0,0],"imageUrls":["\/storage\/images\/resized\/bRyGpdm98BkAUYiK1YFNpl5Z7hPu6Gd87gbIeuG3_medium.webp","\/storage\/images\/resized\/voXLqlsvTwv5p3iMQ8Dhs95nqB4AXOG7Taj7G4ra_medium.webp","\/storage\/images\/resized\/voXLqlsvTwv5p3iMQ8Dhs95nqB4AXOG7Taj7G4ra_medium.webp","\/storage\/images\/resized\/yNSijlgQghQF53VZuyFLA30CKDe4j3HK74Vtpnxa_medium.webp","\/storage\/images\/resized\/9Mus3KG1Tkd7Bwaurt8H3RwWh0CxRlGoO6ng9UK1_medium.webp"],"datasets":[{"label":"","data":[2,1,1,1,1],"backgroundColor":["#3B82F6","#3B82F6","#3B82F6","#3B82F6","#3B82F6"],"percentage":[33.33,16.67,16.67,16.67,16.67],"barThickness":13}]},"options":{"indexAxis":"y","maintainAspectRatio":false,"scales":{"y":{"ticks":{"precision":0,"autoSkip":false,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":false},"x":{"ticks":{"stepSize":null,"precision":0,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":false}},"plugins":{"legend":{"position":"top","labels":{"font":{"family":"Montserrat"},"color":"#000000"}},"title":{"display":true,"text":"Journals","font":{"size":24,"family":"Montserrat","weight":600},"color":"#000000"}}}},"publishers":{"type":"bar","data":{"show":true,"labels":["Wiley","Springer Nature","Oxford University Press","Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii"],"ids":[11,8,19,9422],"codes":[0,0,0,0],"imageUrls":["\/storage\/images\/resized\/bRyGpdm98BkAUYiK1YFNpl5Z7hPu6Gd87gbIeuG3_medium.webp","\/storage\/images\/resized\/voXLqlsvTwv5p3iMQ8Dhs95nqB4AXOG7Taj7G4ra_medium.webp","\/storage\/images\/resized\/yNSijlgQghQF53VZuyFLA30CKDe4j3HK74Vtpnxa_medium.webp","\/storage\/images\/resized\/9Mus3KG1Tkd7Bwaurt8H3RwWh0CxRlGoO6ng9UK1_medium.webp"],"datasets":[{"label":"","data":[2,2,1,1],"backgroundColor":["#3B82F6","#3B82F6","#3B82F6","#3B82F6"],"percentage":[33.33,33.33,16.67,16.67],"barThickness":13}]},"options":{"indexAxis":"y","maintainAspectRatio":false,"scales":{"y":{"ticks":{"precision":0,"autoSkip":false,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":false},"x":{"ticks":{"stepSize":null,"precision":0,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":false}},"plugins":{"legend":{"position":"top","labels":{"font":{"family":"Montserrat"},"color":"#000000"}},"title":{"display":true,"text":"Publishers","font":{"size":24,"family":"Montserrat","weight":600},"color":"#000000"}}}},"yearsCitationsQuartiles":{"type":"bar","data":{"show":true,"labels":[2023,2024],"ids":[],"codes":[],"imageUrls":[],"datasets":[{"label":"Q4","backgroundColor":"rgb(221,90,78)","data":[0,0],"percentage":["0","0"]},{"label":"Q3","backgroundColor":"rgb(251, 163,83)","data":[0,0],"percentage":["0","0"]},{"label":"Q2","backgroundColor":"rgb(232, 213, 89)","data":[0,1],"percentage":["0","16.67"]},{"label":"Q1","backgroundColor":"rgb(164, 207, 99)","data":[3,2],"percentage":["50","33.33"]},{"label":"Quartile not defined","backgroundColor":"#E5E7EB","data":[0,0],"percentage":["0","0"]}]},"options":{"indexAxis":"x","maintainAspectRatio":true,"scales":{"y":{"ticks":{"precision":0,"autoSkip":false,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":true},"x":{"ticks":{"stepSize":1,"precision":0,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":true}},"plugins":{"legend":{"position":"top","labels":{"font":{"family":"Montserrat"},"color":"#000000"}},"title":{"display":true,"text":"Citations quartiles by SCImago per year","font":{"size":24,"family":"Montserrat","weight":600},"color":"#000000"}}}},"yearsCitationsQuartilesWs":{"type":"bar","data":{"show":true,"labels":[2023,2024],"ids":[],"codes":[],"imageUrls":[],"datasets":[{"label":"Q4","backgroundColor":"rgb(221,90,78)","data":[0,0],"percentage":["0","0"]},{"label":"Q3","backgroundColor":"rgb(251, 163,83)","data":[0,0],"percentage":["0","0"]},{"label":"Q2","backgroundColor":"rgb(232, 213, 89)","data":[2,2],"percentage":["33.33","33.33"]},{"label":"Q1","backgroundColor":"rgb(164, 207, 99)","data":[1,1],"percentage":["16.67","16.67"]},{"label":"Quartile not defined","backgroundColor":"#E5E7EB","data":[0,0],"percentage":["0","0"]}]},"options":{"indexAxis":"x","maintainAspectRatio":true,"scales":{"y":{"ticks":{"precision":0,"autoSkip":false,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":true},"x":{"ticks":{"stepSize":1,"precision":0,"font":{"family":"Montserrat"},"color":"#000000"},"stacked":true}},"plugins":{"legend":{"position":"top","labels":{"font":{"family":"Montserrat"},"color":"#000000"}},"title":{"display":true,"text":"Citations quartiles by WoS per year","font":{"size":24,"family":"Montserrat","weight":600},"color":"#000000"}}}}}
Are you a researcher?
Create a profile to get free access to personal recommendations for colleagues and new articles.
Metrics
Cite this
GOST |
RIS |
BibTex
Cite this
GOST
Copy
Prins M. L. M. et al. Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID‐19: A phase 2a, open‐label, single‐dose escalation study // British Journal of Clinical Pharmacology. 2022.
GOST all authors (up to 50)
Copy
Prins M. L. M., Van Der Plas J. L., Vissers M. F., Berends C. L., Tresch G., Soergel M., Fernández E., Van Den Berge N., Duijsings D., ZITT C., Stavropoulou V., Zimmermann M., Drake R. F., Burggraaf J., Groeneveld G. H., Kamerling I. M. C. Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID‐19: A phase 2a, open‐label, single‐dose escalation study // British Journal of Clinical Pharmacology. 2022.
Cite this
RIS
Copy
TY - JOUR
DO - 10.1111/bcp.15560
UR - https://doi.org/10.1111/bcp.15560
TI - Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID‐19: A phase 2a, open‐label, single‐dose escalation study
T2 - British Journal of Clinical Pharmacology
AU - Prins, Manon L M
AU - Van Der Plas, Johan L
AU - Vissers, Maurits F.J.M.
AU - Berends, Cécile L
AU - Tresch, Gaby
AU - Soergel, Marianne
AU - Fernández, Elena
AU - Van Den Berge, Nikita
AU - Duijsings, Daniël
AU - ZITT, Christof
AU - Stavropoulou, Vaia
AU - Zimmermann, Maya
AU - Drake, Roxana F
AU - Burggraaf, Jacobus
AU - Groeneveld, Geert H
AU - Kamerling, Ingrid M. C.
PY - 2022
DA - 2022/10/24 00:00:00
PB - Wiley
SN - 0306-5251
SN - 1365-2125
ER -
Cite this
BibTex
Copy
@article{2022_Prins,
author = {Manon L M Prins and Johan L Van Der Plas and Maurits F.J.M. Vissers and Cécile L Berends and Gaby Tresch and Marianne Soergel and Elena Fernández and Nikita Van Den Berge and Daniël Duijsings and Christof ZITT and Vaia Stavropoulou and Maya Zimmermann and Roxana F Drake and Jacobus Burggraaf and Geert H Groeneveld and Ingrid M. C. Kamerling},
title = {Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID‐19: A phase 2a, open‐label, single‐dose escalation study},
journal = {British Journal of Clinical Pharmacology},
year = {2022},
publisher = {Wiley},
month = {oct},
url = {https://doi.org/10.1111/bcp.15560},
doi = {10.1111/bcp.15560}
}