NCT04681092 (ACT) is a Phase 1, PHASE2 clinical trial of AKS-452 in Covid19, sponsored by University Medical Center Groningen.

Who is sponsoring NCT04681092?

NCT04681092 is sponsored by University Medical Center Groningen.

What drugs are being tested in NCT04681092?

Interventions in NCT04681092: AKS-452.

Is NCT04681092 still recruiting?

NCT04681092 is currently completed. Last updated 16 April 2024.

Last reviewed 2024-04-16 · How we verify

NCT04681092: ACT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study

Completed Phase 1, PHASE2 Last updated 16 April 2024

What this trial tests

Phase 1, PHASE2 trial testing AKS-452 in Covid19 in 112 participants. Completed in 10 March 2022.

Timeline

6 April 2021

Primary endpoint
10 March 2022

10 March 2022

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	112
Start date	6 April 2021
Primary completion	10 March 2022
Estimated completion	10 March 2022
Sites	1 location across Netherlands

Drugs / interventions tested

AKS-452 — full drug profile →

Conditions studied

Covid19 — all drugs for Covid19 →

Sponsor

University Medical Center Groningen

Who can join

Adults 18 to 85, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Scientific rationale for developing potent RBD-based vaccines targeting COVID-19.
Kleanthous H, Silverman JM, Makar KW, Yoon IK, et al · · 2021 · cited 118× · PMID 34711846 · DOI 10.1038/s41541-021-00393-6
The impact of spike mutated variants of SARS-CoV2 [Alpha, Beta, Gamma, Delta, and Lambda] on the efficacy of subunit recombinant vaccines.
Mohammadi M, Shayestehpour M, Mirzaei H. · · 2021 · cited 99× · PMID 34428473 · DOI 10.1016/j.bjid.2021.101606
COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
A Narrative Review of COVID-19 Vaccines.
Eroglu B, Nuwarda RF, Ramzan I, Kayser V. · · 2021 · cited 38× · PMID 35062723 · DOI 10.3390/vaccines10010062
An update review of globally reported SARS-CoV-2 vaccines in preclinical and clinical stages.
Motamedi H, Ari MM, Dashtbin S, Fathollahi M, et al · · 2021 · cited 34× · PMID 34162141 · DOI 10.1016/j.intimp.2021.107763
Development of an IgG-Fc fusion COVID-19 subunit vaccine, AKS-452.
Alleva DG, Delpero AR, Scully MM, Murikipudi S, et al · · 2021 · cited 32× · PMID 34642088 · DOI 10.1016/j.vaccine.2021.09.077
Recombinant Protein Vaccines against Human Betacoronaviruses: Strategies, Approaches and Progress.
Kovalenko A, Ryabchevskaya E, Evtushenko E, Nikitin N, et al · · 2023 · cited 15× · PMID 36675218 · DOI 10.3390/ijms24021701
Pharmaceutical Aspects and Clinical Evaluation of COVID-19 Vaccines.
Hofman K, Shenoy GN, Chak V, Balu-Iyer SV. · · 2021 · cited 15× · PMID 33929280 · DOI 10.1080/08820139.2021.1904977

Verify or expand the search:

Other recruiting trials for Covid19

Currently open trials in the same condition.

NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix · EARLY_PHASE1 · active not recruiting
NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation · NA · recruiting
NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs · NA · active not recruiting
NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
NCT04806061 — Urine Alkalinisation in COVID-19 · NA · active not recruiting

Other University Medical Center Groningen trials

Trials by the same sponsor.

NCT06647602 — Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy · not yet recruiting
NCT06809946 — Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy · Phase 2 · not yet recruiting
NCT07527390 — CANagliflozin In DIALysis Patients · Phase 4 · not yet recruiting
NCT07439237 — Implant-supported Maxillary Overdentures; a 15-years Evaluation · not yet recruiting
NCT07275437 — Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fra · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04681092 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
Last refreshed: 16 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04681092.

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