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SOLIDARITY Finland Plus Long-COVID

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05220280
Recruitment Status : Recruiting
First Posted : February 2, 2022
Last Update Posted : May 3, 2022
Sponsor:
Collaborators:
University of Helsinki
World Health Organization
Helsinki University Central Hospital
Hyvinkää Hospital
Kanta-Häme Central Hospital
Kuopio University Hospital
City of Helsinki
Oulu University Hospital
Porvoo Hospital
Seinajoki Central Hospital
Mikkeli Central Hospital
Tampere University Hospital
Information provided by (Responsible Party):
Kari Tikkinen, University of Helsinki

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.

Condition or disease Intervention/treatment Phase
Covid19 Coronavirus Disease 2019 SARS-CoV-2 Acute Respiratory Disease Drug: Imatinib Drug: Infliximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label trial
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Local standard of care
Experimental: Imatinib + local standard of care Drug: Imatinib
Oral imatinib 400 mg tablet once a day for 14 days.

Experimental: Infliximab + local standard of care Drug: Infliximab
Infliximab is administered as a single IV infusion with the proposed dosing schedule of 5 mg/kg body weight.




Primary Outcome Measures :
  1. Long-COVID symptoms [ Time Frame: At six months from hospital admission. ]
    Specific questionnaire for symptoms and their severity

  2. Long-COVID symptoms [ Time Frame: At one year from hospital admission. ]
    Specific questionnaire for symptoms and their severity

  3. Long-COVID symptoms [ Time Frame: At two years from hospital admission. ]
    Specific questionnaire for symptoms and their severity

  4. Health-related quality of life [ Time Frame: At six months from hospital admission ]
    EQ-5D-5L questionnaire

  5. Health-related quality of life [ Time Frame: At one year from hospital admission ]
    EQ-5D-5L questionnaire

  6. Health-related quality of life [ Time Frame: At two years from hospital admission ]
    EQ-5D-5L questionnaire


Secondary Outcome Measures :
  1. Mortality [ Time Frame: During one and two years from hospital admission ]
    Obtained from health care registries

  2. Incidence of comorbidity [ Time Frame: During two years from hospital admission ]
    Obtained from health care registries

  3. Lung function [ Time Frame: At two years from hospital admission ]
    Spirometry

  4. Lung function [ Time Frame: At two years from hospital admission ]
    Lung diffusion capacity

  5. Lung function [ Time Frame: At two years from hospital admission ]
    6-minute walking test

  6. Whole-genome sequencing [ Time Frame: Within 2 years from hospital discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Kari AO Tikkinen, MD PhD +358406510530 kari.tikkinen@helsinki.fi
Contact: Saana Horstia, RN saana.horstia@hus.fi

Locations
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Finland
University of Helsinki Recruiting
Helsinki, Finland, 00014
Contact: Kari AO Tikkinen, MD PhD    +358406510530    kari.tikkinen@helsinki.fi   
Contact: Saana Horstia, RN       saana.horstia@hus.fi   
Sponsors and Collaborators
Clinical Urology and Epidemiology Working Group
University of Helsinki
World Health Organization
Helsinki University Central Hospital
Hyvinkää Hospital
Kanta-Häme Central Hospital
Kuopio University Hospital
City of Helsinki
Oulu University Hospital
Porvoo Hospital
Seinajoki Central Hospital
Mikkeli Central Hospital
Tampere University Hospital
Investigators
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Study Director: Kari AO Tikkinen, MD PhD University of Helsinki
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Responsible Party: Kari Tikkinen, Professor, University of Helsinki
ClinicalTrials.gov Identifier: NCT05220280    
Other Study ID Numbers: SOLP21
First Posted: February 2, 2022    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kari Tikkinen, University of Helsinki:
Long COVID
imatinib
infliximab
Additional relevant MeSH terms:
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COVID-19
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Imatinib Mesylate
Infliximab
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents