The primary aim of the SOLIDARITY Finland Long-COVID trial is to assess the long-term effects
of remdesivir use during hospitalisation on long-COVID symptoms and quality of life (QoL)
using questionnaires at one and two years post-discharge. The primary research questions are
whether remdesivir lowers the risk of long-COVID symptoms and leads to better QoL in the long
term.
Objectives include:
i) Long-COVID symptoms
- To investigate the effect of remdesivir (vs. usual care only) on the occurrence of
symptoms that have been associated with the long-COVID syndrome. The questionnaires will
take place one and two years after the hospital admission. The questionnaire was
developed by our multidisciplinary team of physicians, including the representation of
multiple specialties such as general practice, lung diseases, neurology, internal
medicine, rheumatology, genetics, and clinical epidemiology, and two patient partners.
- The symptom questionnaire - that will be completed by patients at one and two years -
measures basic patient information (age, height, weight, smoking status, major
comorbidity, and working status) and a wide variety of potential long-COVID-symptoms and
their bother (1. Fatigue; 2. Attention deficits; 3. Memory problems; 4. Sleeping
difficulties; 5. Depressive mood; 6. Anxiety; 7. Dizziness; 8. Headache; 9. Tinnitus;
10. Paresthesias; 11. Changes in taste/smell perceptions; 12. Postexertional malaise;
13. Palpitations; 14. Chest discomfort; 15. Nausea; 16. Skin rash; 17. Joint aches; 18.
Muscle pains; 19. Continuous cough; 20. Respiratory tract mucous discharges) in
remdesivir and usual care arms
ii) Quality of life
- The EQ-5D-5L questionnaire will be used to compare patients' quality of life in
remdesivir and usual care arms.
- EQ-5D-5L questionnaire assesses the following domains: 1. Mobility; 2. Self-care; 3.
Usual activities; 4. Pain and discomfort; 5. Anxiety and depression; 6. The visual
analog scale of subjective perception of overall health.
Additionally (at 1 or 2 years; depending on future funding and ethical approval decisions;
currently the study has ethical approval for long-COVID and quality of life assessments
only):
- The Finnish healthcare registries (Statistics Finland Mortality Database and the HILMO
Care Register for Health Care) will be used to estimate long-term mortality and
incidence of major comorbidity in remdesivir and usual care arms
- Lung function will be assessed using spirometry and diffusing capacity, as well as the
six-minute walk test (6 mwt) in remdesivir and usual care arms
- Whole-genome genotyping will be performed for a genome-wide association study to
investigate genetic correlates of long-COVID-19 -symptoms in remdesivir and usual care
arms
Phase:
Phase 4
Details
Lead Sponsor:
Clinical Urology and Epidemiology Working Group
Collaborators:
Helsinki University Central Hospital Hyvinkää Hospital Kanta-Häme Central Hospital Kuopio University Hospital Mikkeli Central Hospital Oulu University Hospital Porvoo Hospital Seinajoki Central Hospital Tampere University Hospital University of Helsinki World Health Organization