SOLIDARITY Finland Long COVID-19

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Remdesivir

Criteria

Inclusion Criteria:

• Alive patients who attended the SOLIDARITY Finland remdesivir sub-study

Eligibility criteria for SOLIDARITY Finland remdesivir -study:

Inclusion criteria:

• Adult patients, 18 years and older

• Laboratory-confirmed SARS-CoV-2 infection

• Admitted to the hospital ward or the intensive care unit (ICU)

• Patient provides written informed consent prior to initiation of the study OR close relative/legal representative provides written informed consent prior to initiation of the study according to the presumed will of the patient when patient is unable to give consent.

• No anticipated transfer within 72 hours to a non-study hospital

Exclusion Criteria:

• Severe co-morbidity with life expectancy <3 months according to investigators assessment

• ASAT/ALAT > 5 times the upper limit of normal

• Acute co-morbidity within 7 days before inclusion such as myocardial infarction or unstable angina pectoris (not including troponin elevation due to infection)

• Pregnancy or breast feeding

• Any reason why, in the opinion of the investigators, the patient should not participate

• Subject participates in a potentially confounding drug or device trial during the course of the study

• Already receiving the study drug

• Renal failure (eGRF < 30 mL/min) or dialysis/continuous veno-venous hemofiltration