SOLIDARITY Finland Long-COVID (Remdesivir Long-term Follow-up Study of COVID Patients)
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ClinicalTrials.gov Identifier: NCT04978259 |
Recruitment Status :
Recruiting
First Posted : July 27, 2021
Last Update Posted : July 15, 2022
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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:
- EQ-VAS
- EQ-5D-5L, summary
- Does the patient feel recovered from COVID-19-infection at one year or not? (question no. 10)
- Fatigue (questionnaire, question no. 14)
- Exertional dyspnea (question no. 12)
Condition or disease | Intervention/treatment | Phase |
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Covid19 | Drug: Remdesivir | Phase 4 |
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 |
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)
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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
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- 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.
- 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.
- 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"
- Fatigue [ Time Frame: 1 year ]The presence of fatigue as: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, and 3 = severe fatigue.
- 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.
- 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
- 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.
- 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.
- 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"
- Fatigue [ Time Frame: 2 year ]The presence of fatigue as: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, and 3 = severe fatigue.
- 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.
- 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
- Mortality [ Time Frame: Long-term at one year ]Obtiained from health care registries
- Incidence of comorbidity [ Time Frame: Long-term at one year, obtained from registries ]Obtiained from health care registries
- 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)
- 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.
- Lung function [ Time Frame: 2 years post-discharge ]6-minute walking test
- 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 |
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
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
Contact: Kari AO Tikkinen, MD PhD | +358406510530 | kari.tikkinen@helsinki.fi | |
Contact: Saana Horstia, RN | saana.horstia@hus.fi |
Finland | |
University of Helsinki | Recruiting |
Helsinki, Finland, 00014 | |
Contact: Kari AO Tikkinen +358406510530 kari.tikkinen@helsinki.fi | |
Contact: Saana Horstia saana.horstia@hus.fi |
Study Director: | Kari AO Tikkinen, MD PhD | University of Helsinki | |
Principal Investigator: | Olli Nevalainen, MD PhD | University of Helsinki |
Documents provided by Kari Tikkinen, Clinical Urology and Epidemiology Working Group:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
long-COVID COVID randomised trial evidence-based medicine remdesivir symptoms |
quality of life mortality morbidity genetics Covid19 |
COVID-19 Post-Acute COVID-19 Syndrome 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 Remdesivir Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |