SOLIDARITY Finland Plus Long-COVID
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|ClinicalTrials.gov Identifier: NCT05220280|
Recruitment Status : Recruiting
First Posted : February 2, 2022
Last Update Posted : May 3, 2022
The SOLIDARITY PLUS Finland Long-COVID trial aims to assess the long-term effects of imatinib and infliximab, used during acute hospitalization due to COVID-19-infection, on long-COVID symptoms and quality of life (QoL) using questionnaires at six months, one and two years post-discharge. The primary research questions are whether imatinib or infliximab lower the risk of long-COVID symptoms and leads to better QoL in the long term.
i) Long-COVID symptoms
To investigate the effect of imatinib (vs. usual care only) and infliximab (vs. usual care only) on the occurrence of symptoms that have been associated with the long-COVID syndrome. The questionnaires will take place at six months, one and two years after the hospital admission. The questionnaire will be the same that has been used in the SOLIDARITY Finland Long-COVID trial on remdesivir. 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).
ii) Quality of life
The EQ-5D-5L questionnaire will be used to compare patients' quality of life in imatinib, infliximab, 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):
- The Finnish healthcare registries (such as Statistics Finland Mortality Database, the HILMO Care Register for Health Care, and/or Digital and Population Data Services Agency (Finnish Digital Agency)) will be used to estimate long-term mortality and incidence of major comorbidity in treatment arms.
- Lung function will be assessed using spirometry and diffusing capacity, as well as the six-minute walk test (6 mwt) in treatment arms.
- Whole-genome genotyping will be performed for a genome-wide association study to investigate genetic correlates of long-COVID-19 -symptoms in treatment arms.
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Coronavirus Disease 2019 SARS-CoV-2 Acute Respiratory Disease||Drug: Imatinib Drug: Infliximab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label trial|
|Official Title:||Long-term Follow-up of a Randomized Multicenter Trial on Impact of Imatinib and Infliximab on Long-COVID in Hospitalized COVID-19 Patients|
|Actual Study Start Date :||February 6, 2022|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
|No Intervention: Local standard of care|
|Experimental: Imatinib + local standard of care||
Oral imatinib 400 mg tablet once a day for 14 days.
|Experimental: Infliximab + local standard of care||
Infliximab is administered as a single IV infusion with the proposed dosing schedule of 5 mg/kg body weight.
- Long-COVID symptoms [ Time Frame: At six months from hospital admission. ]Specific questionnaire for symptoms and their severity
- Long-COVID symptoms [ Time Frame: At one year from hospital admission. ]Specific questionnaire for symptoms and their severity
- Long-COVID symptoms [ Time Frame: At two years from hospital admission. ]Specific questionnaire for symptoms and their severity
- Health-related quality of life [ Time Frame: At six months from hospital admission ]EQ-5D-5L questionnaire
- Health-related quality of life [ Time Frame: At one year from hospital admission ]EQ-5D-5L questionnaire
- Health-related quality of life [ Time Frame: At two years from hospital admission ]EQ-5D-5L questionnaire
- Mortality [ Time Frame: During one and two years from hospital admission ]Obtained from health care registries
- Incidence of comorbidity [ Time Frame: During two years from hospital admission ]Obtained from health care registries
- Lung function [ Time Frame: At two years from hospital admission ]Spirometry
- Lung function [ Time Frame: At two years from hospital admission ]Lung diffusion capacity
- Lung function [ Time Frame: At two years from hospital admission ]6-minute walking test
- Whole-genome sequencing [ Time Frame: Within 2 years from hospital discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05220280
|Contact: Kari AO Tikkinen, MD PhDfirstname.lastname@example.org|
|Contact: Saana Horstia, RNemail@example.com|
|Study Director:||Kari AO Tikkinen, MD PhD||University of Helsinki|