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SOLIDARITY Finland Long-COVID (Remdesivir Long-term Follow-up Study of COVID Patients)

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: NCT04978259
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : July 15, 2022
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:

SOLIDARITY Finland Long-COVID trial assesses the effects of remdesivir + standard of care (SoC) vs. only SoC on long-COVID symptoms and quality of life (QoL) using questionnaires at one and two years post-discharge.

Objectives i) Long-COVID symptoms

  • To investigate the effect of remdesivir (vs. SoC) on the occurrence of symptoms that have been associated with the long-COVID syndrome. The questionnaires will take place 1 and 2 years after the hospital admission.
  • 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

  • EQ-VAS: 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 VAS 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

UPDATE 02.02.2022:

Primary outcomes will comprise the following:

  1. EQ-VAS
  2. EQ-5D-5L, summary
  3. Does the patient feel recovered from COVID-19-infection at one year or not? (question no. 10)
  4. Fatigue (questionnaire, question no. 14)
  5. Exertional dyspnea (question no. 12)

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
Actual Study Start Date : July 24, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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. EQ-VAS [ Time Frame: 1 year ]

    EQ-VAS is a patient-reported outcome measure of quality of life on a scale from 0 to 100.

    The minimum scores mean a worse outcome.


  2. EQ-5D-5L [ Time Frame: 1 year ]
    Quality of life measure of five domains, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  3. Recovering from COVID-19 infection [ Time Frame: 1 year ]
    Question: How do you feel you have recovered from the COVID-19 infection you had one year ago? Five options from "fully recovered" to "not recovered at all"

  4. Fatigue [ Time Frame: 1 year ]
    The presence of fatigue as: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, and 3 = severe fatigue.

  5. Exertional dyspnea [ Time Frame: 1 year ]
    mMRC scale measures the degree of disability that breathlessness poses on everyday activities on a scale from 0 to 4.

  6. Long-COVID symptoms [ Time Frame: 1 year ]
    Infection affected quality of life in the last month as: 0 = No symptoms of infection, 1 = Slight harm, 2 = Moderate harm, 3 = Severe harm


Secondary Outcome Measures :
  1. EQ-VAS [ Time Frame: 2 year ]
    EQ-VAS is a patient-reported outcome measure of quality of life on a scale from 0 to 100 The minimum scores mean a worse outcome.

  2. EQ-5D-5L [ Time Frame: 2 year ]
    Quality of life measure of five domains, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  3. Recovering from COVID-19 infection [ Time Frame: 2 year ]
    Question: How do you feel you have recovered from the COVID-19 infection you had one year ago? Five options from "fully recovered" to "not recovered at all"

  4. Fatigue [ Time Frame: 2 year ]
    The presence of fatigue as: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, and 3 = severe fatigue.

  5. Exertional dyspnea [ Time Frame: 2 year ]
    mMRC scale measures the degree of disability that breathlessness poses on everyday activities on a scale from 0 to 4.

  6. Long-COVID symptoms [ Time Frame: 2 year ]
    Infection affected quality of life in the last month as: 0 = No symptoms of infection, 1 = Slight harm, 2 = Moderate harm, 3 = Severe harm


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: VC, FVC, FEV1, FEV1/VC, peak expiratory flow (PEF), the maximal expiratory flow at 50 % (MEF50), and the forced expiratory time (FET)

  4. Lung function [ Time Frame: 2 years post-discharge ]
    Lung diffusion capacity: Diffusing capacity parameter DLCO is a continuous variable with ml/min/mmHg as the unit.

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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:
Informed Consent Form  [PDF] June 30, 2021

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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 15, 2022
Last Verified: June 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, 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