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SOLIDARITY Finland Long COVID-19

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ClinicalTrials.gov Identifier: NCT04978259
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : July 27, 2021
Sponsor:
Collaborators:
University of Helsinki
World Health Organization
Helsinki University Central Hospital
Hyvinkää Hospital
Kanta-Häme Central Hospital
Kuopio University Hospital
Oulu University Hospital
Porvoo Hospital
Seinajoki Central Hospital
Mikkeli Central Hospital
Tampere University Hospital
Information provided by (Responsible Party):
Kari Tikkinen, Clinical Urology and Epidemiology Working Group

Brief 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

Condition or disease Intervention/treatment Phase
Covid19 Drug: Remdesivir Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Follow-up of a Randomized Multicenter Trial on Impact of Long-COVID in Hospitalized COVID-19 Patients
Estimated Study Start Date : July 21, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Standard of care plus remdesivir
Local standard of care plus daily remdesivir infusion for up to 10 days (or until discharge)
Drug: Remdesivir
Intravenous remdesivir during hospital stay up to 10 days in addition to standard care.

No Intervention: Standard of care
Local standard of care



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

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

  3. Quality of life (QoL) [ Time Frame: At one year from hospital admission ]

    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. Visual analogue scale of subjective perception of overall health. Questions 1-5 are ordinal variables and the trouble severity has five degrees of severity from no trouble to the most extreme form of trouble. Question 6 is a VAS scale from 0-100, where 0 represents the worst and 100 the best possible overall state of health.


  4. Quality of life (QoL) [ Time Frame: At two years from hospital admission ]

    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. Visual analogue scale of subjective perception of overall health. Questions 1-5 are ordinal variables and the trouble severity has five degrees of severity from no trouble to the most extreme form of trouble. Question 6 is a VAS scale from 0-100, where 0 represents the worst and 100 the best possible overall state of health.



Other Outcome Measures:
  1. Mortality [ Time Frame: Long-term at one year ]
    Obtiained from health care registries

  2. Incidence of comorbidity [ Time Frame: Long-term at one year, obtained from registries ]
    Obtiained from health care registries

  3. Lung function [ Time Frame: 2 years post-discharge ]
    Spirometry

  4. Lung function [ Time Frame: 2 years post-discharge ]
    Lung diffusion capacity

  5. Lung function [ Time Frame: 2 years post-discharge ]
    6-minute walking test

  6. Whole-genome sequencing [ Time Frame: 2 years post-discharge ]


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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:

  • 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

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): NCT04978259


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    +358406510530    kari.tikkinen@helsinki.fi   
Contact: Saana Horstia       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
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
Principal Investigator: Olli Nevalainen, MD PhD University of Helsinki
  Study Documents (Full-Text)

Documents provided by Kari Tikkinen, Clinical Urology and Epidemiology Working Group:
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Responsible Party: Kari Tikkinen, Professor, Clinical Urology and Epidemiology Working Group
ClinicalTrials.gov Identifier: NCT04978259    
Other Study ID Numbers: SOL21
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021

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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, Clinical Urology and Epidemiology Working Group:
long-COVID
COVID
randomised trial
evidence-based medicine
remdesivir
symptoms
quality of life
mortality
morbidity
genetics
Covid19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Remdesivir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents