SOLIDARITY Finland Plus Long-COVID

NCT05220280 | Unknown Phase 4

• 1 other identifier: SOLP21
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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. Objectives include: 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.

Conditions

Covid19; Coronavirus Disease 2019; SARS-CoV-2 Acute Respiratory Disease

Keywords

Long COVID; imatinib; infliximab

Outcome Measures

Primary Outcomes (6)

• Long-COVID symptoms

  Specific questionnaire for symptoms and their severity

  At six months from hospital admission.

• Long-COVID symptoms

  Specific questionnaire for symptoms and their severity

  At one year from hospital admission.

• Long-COVID symptoms

  Specific questionnaire for symptoms and their severity

  At two years from hospital admission.

• Health-related quality of life

  EQ-5D-5L questionnaire

  At six months from hospital admission

• Health-related quality of life

  EQ-5D-5L questionnaire

  At one year from hospital admission

• Health-related quality of life

  EQ-5D-5L questionnaire

  At two years from hospital admission

Secondary Outcomes (6)

• Mortality

  During one and two years from hospital admission

• Incidence of comorbidity

  During two years from hospital admission

• Lung function

  At two years from hospital admission

• Lung function

  At two years from hospital admission

• Lung function

  At two years from hospital admission

Study Arms (3)

Local standard of care

NO INTERVENTION

Imatinib + local standard of care

EXPERIMENTAL

Drug: Imatinib

Infliximab + local standard of care

EXPERIMENTAL

Drug: Infliximab

Interventions

Imatinib DRUG

Oral imatinib 400 mg tablet once a day for 14 days.

Imatinib + local standard of care

Infliximab DRUG

Infliximab is administered as a single IV infusion with the proposed dosing schedule of 5 mg/kg body weight.

Infliximab + local standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, 18 years and above
• SARS-2-CoV-2 infection, laboratory-confirmed
• Admission to the hospital ward or ICU
• Written informed consent prior to initiation of the study or a close relative/legal representative provides written informed consent prior to initiation of the study according to the presumed will of the patient when the patient is unable to give consent herself/himself.
• No anticipated transfer within 72 hours to a non-study hospital

You may not qualify if:

• Estimated life expectancy under three months due to severe comorbidity
• ASAT/ALAT-ratio over five-fold upper limit
• Acute myocardial infarction or unstable angina pectoris
• Breast feeding or pregnancy
• Any reason why, in the opinion of the investigators, the patient should not participate
• Patient participates in a potentially confounding drug or device trial during the course of the study
• Already receiving any of the study drugs
• Severe renal failure (eGFR \< 30 mL/min)

Sponsors & Collaborators

• Clinical Urology and Epidemiology Working Group: lead
• University of Helsinki: collaborator
• World Health Organization: collaborator
• Helsinki University Central Hospital: collaborator
• Hyvinkää Hospital: collaborator
• Kanta-Häme Central Hospital: collaborator
• Kuopio University Hospital: collaborator
• City of Helsinki: collaborator
• Oulu University Hospital: collaborator
• Porvoo Hospital: collaborator
• Seinajoki Central Hospital: collaborator
• Mikkeli Central Hospital: collaborator
• Tampere University Hospital: collaborator

Study Sites (1)

University of Helsinki

Helsinki, 00014, Finland

RECRUITING

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Imatinib Mesylate; Infliximab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kari AO Tikkinen, MD PhD

  University of Helsinki

  STUDY DIRECTOR

Central Study Contacts

Kari AO Tikkinen, MD PhD

CONTACT

+358406510530; kari.tikkinen@helsinki.fi

Saana Horstia, RN

CONTACT

saana.horstia@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 2, 2022
• Study Start: February 6, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

FI (1)