COVID-19
Conditions
Keywords
COVID-19, Vaccination, Pragmatic, Registry, Respiratory tract disease, Respiratory, Cardiovascular
Brief summary
The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of the COVID-19 vaccine, mRNA-1273, in adults aged 50-64 years without known risk factors for severe COVID-19 infection. Participants will be randomized 1:1 to either COVID-19 vaccine or no COVID-19 vaccine.
Detailed description
The study is a pragmatic, registry-based, open-label, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize a total of 285,000 participants. Participants will be individually randomized 1:1 to receive either a COVID-19 vaccine or no COVID-19 vaccine. The study is designed to assess the vaccine effectiveness of the COVID-19 vaccine vs. no COVID-19 vaccine on the risk of medically attended COVID-19 infection.
Interventions
BIOLOGICALmRNA-1273 (Moderna COVID-19 vaccine)
For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used.
Sponsors
Tor Biering-Sørensen
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 50-64 years * Informed consent form has been signed and dated
Exclusion criteria
* Medical conditions that increase the risk of severe COVID-19, which will be assessed through self-reporting. These medical conditions include: 1. Asthma 2. Cancer (excluding non-melanoma skin cancer) 3. Cardiomyopathies 4. Cerebrovascular disease 5. Chronic kidney disease 6. Chronic lung disease 7. Cystic Fibrosis 8. Dementia 9. Diabetes 10. Down syndrome 11. Heart failure 12. Human Immunodeficiency Virus 13. Immunosuppressive therapy 14. Ischemic heart disease 15. Liver disease 16. Neurological/neuromuscular disease 17. Psychiatric disease (psychotic, schizophrenic, schizotypal, depressive, and bipolar (affective) disorders). 18. Severe obesity (body mass index \>35 kg/m2) 19. Severe substance abuse 20. Short bowel syndrome 21. Solid organ transplant or hematological transplant * Apart from these, there are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medically attended COVID-19 | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date | Defined as a positive PCR test for SARS-CoV-2 or hospitalization for COVID-19-related respiratory tract disease |
Secondary
| Measure | Time frame |
|---|---|
| COVID-19-related hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| COVID-19-related respiratory tract disease hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| COVID-19-related cardio-respiratory disease hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| All-cause respiratory tract disease hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| All-cause cardio-respiratory hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| All-cause lower respiratory tract disease hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| All-cause hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| COVID-19 death | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| All-cause death | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
Countries
Denmark
Contacts
STUDY_CHAIRTor Biering-Sørensen, MD, MSc, MPH, PhD
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Outcome results
None listed