Clinical trial • Phase IV • Infectious Disease

elasomeran (ELASOMERAN / mRNA-1273) for SARS-CoV-2 infection

Phase IV trial of elasomeran (ELASOMERAN / mRNA-1273) for SARS-CoV-2 infection.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
SARS-CoV-2 infection
Trial Stage
Phase IV
Drug Modality
mRNA

Key dates

Initial CTIS Submission Date
29-09-2025
First CTIS Authorization Date
26-11-2025

Trial design

Randomised, placebo (saline) / no vaccine (as stated in trial justification). active comparator: spikevax (mrna-1273 / elasomeran) 50 micrograms dispersion for injection in pre-filled syringe (0.5 ml intramuscular).-controlled Phase IV trial across 2 sites in Denmark.

Randomised
Yes
Comparator
Placebo (saline) / no vaccine (as stated in trial justification). Active comparator: Spikevax (mRNA-1273 / elasomeran) 50 micrograms dispersion for injection in pre-filled syringe (0.5 ml intramuscular).
Target Sample Size
275000

Eligibility

Recruits 275000 No vulnerable population selected; standard informed consent is required from participants (informed consent form to be signed and dated)..

Vulnerable Population
No vulnerable population selected; standard informed consent is required from participants (informed consent form to be signed and dated).

Inclusion criteria

  • {"criterion_text":"- Age 50-64 years"}
  • {"criterion_text":"- Informed consent form has been signed and dated"}

Exclusion criteria

  • {"criterion_text":"- The trial has no formal exclusion criteria"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Medically attended COVID-19, defined as a positive PCR test for SARS-CoV-2 or hospitalization for COVID-19-related respiratory tract disease. The prespecified registry-based definition of the primary endpoint is as follows: Medically attended COVID-19 (ICD-10 codes: B342, B972, U071) diagnosis type: A. Requires either a positive SARS-CoV-2 PCR test from the Danish Microbiology Database OR COVID-19-related hospitalization","definition_or_measurement_approach":"Registry-based definition: positive SARS-CoV-2 PCR test from the Danish Microbiology Database OR COVID-19-related hospitalization; ICD-10 codes B342, B972, U071 used to identify cases."}

Secondary endpoints

  • {"endpoint_text":"- 1.\tCOVID-19-related hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 2.\t COVID-19-related respiratory tract disease hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3.\tCOVID-19-related cardio-respiratory disease hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 4.\tAll-cause respiratory tract infection hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 5.\tAll-cause cardio-respiratory hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 6.\tAll-cause lower respiratory tract disease hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 7.\tAll-cause hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 8.\tCOVID-19 death","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 9.\tAll-cause death","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
True, website advertisement and online video materials (video transcript) are included in recruitment materials.
Planned Sample Size
275000
Recruitment Window Months
9
Consent Approach
Informed consent form must be signed and dated by the participant. Subject information and informed consent forms available in Danish and English (documents: L1_Samtykkeerklring, L1_DAN-COVID_Deltagerinformation_ENGLISH). No assent process described.

Methods

  • Invitation letter (document: K1_DAN-COVID Invitation letter)
  • Website advertisement (document: K1_DAN-COVID_Website-advertisement)
  • Video (transcript) (document: K1_DAN-COVID_Video-transcript)
  • Use of vaccination service sites (e.g. Danske Lægers Vaccinations Service and hospital sites listed)

Geography

Total Number Of Sites
2
Total Number Of Participants
275000

Denmark

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
5
Number Of Sites
2
Number Of Participants
275000

Sites

Site Name
Danske Lægers Vaccinations Service
Department Name
Danske Lægers vaccinations Service
Contact Person Name
Carsten Schade Larsen
Site Name
Gentofte Hospital
Department Name
Center for translational Cardiology and Pragmatic Randomized Trials
Contact Person Name
Tor Biering-Sørensen

Sponsor

Primary sponsor

Full Name
Gentofte Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsor duties code 1","organisation_type":"Health care"}

Co-sponsors

  • Moderna Inc.

Investigational products

Investigational Product Name
Spikevax 50 micrograms dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
Active Substance
elasomeran (ELASOMERAN / mRNA-1273)
Modality
mRNA
Routes Of Administration
Intramuscular injection
Route
Intramuscular
Authorisation Status
Authorised (marketing authorisation EU/1/20/1507/003)
Starting Dose
50 micrograms (0.5 ml)
Maximum Dose
0.5 ml

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