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

NCT04978259 | Unknown Phase 4

• 1 other identifier: SOL21
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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:
• 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)

Conditions

Covid19

Keywords

long-COVID; COVID; randomised trial; evidence-based medicine; remdesivir; symptoms; quality of life; mortality; morbidity; genetics; Covid19

Outcome Measures

Primary Outcomes (6)

• EQ-VAS

  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.

  1 year

• EQ-5D-5L

  Quality of life measure of five domains, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  1 year

• Recovering from COVID-19 infection

  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"

  1 year

• Fatigue

  The presence of fatigue as: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, and 3 = severe fatigue.

  1 year

• Exertional dyspnea

  mMRC scale measures the degree of disability that breathlessness poses on everyday activities on a scale from 0 to 4.

  1 year

• Long-COVID symptoms

  Infection affected quality of life in the last month as: 0 = No symptoms of infection, 1 = Slight harm, 2 = Moderate harm, 3 = Severe harm

  1 year

Secondary Outcomes (6)

• EQ-VAS

  2 year

• EQ-5D-5L

  2 year

• Recovering from COVID-19 infection

  2 year

• Fatigue

  2 year

• Exertional dyspnea

  2 year

Other Outcomes (6)

• Mortality

  Long-term at one year

• Incidence of comorbidity

  Long-term at one year, obtained from registries

• Lung function

  2 years post-discharge

Study Arms (2)

Standard of care plus remdesivir

EXPERIMENTAL

Local standard of care plus daily remdesivir infusion for up to 10 days (or until discharge)

Drug: Remdesivir

Standard of care

NO INTERVENTION

Local standard of care

Interventions

Remdesivir DRUG

Intravenous remdesivir during hospital stay up to 10 days in addition to standard care.

Standard of care plus remdesivir

Eligibility Criteria

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

You may qualify if:

• Alive patients who attended the SOLIDARITY Finland remdesivir sub-study
• Eligibility criteria for SOLIDARITY Finland remdesivir -study:
• 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

You may not qualify if:

• Severe co-morbidity with life expectancy \<3 months according to investigators assessment
• ASAT/ALAT \> 5 times the upper limit of normal
• 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

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
• 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

Related Publications (1)

• Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.

  PMID: 36695483 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

remdesivir

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

Study Officials

• Kari AO Tikkinen, MD PhD

  University of Helsinki

  STUDY DIRECTOR

• Olli Nevalainen, MD PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 27, 2021
• Study Start: July 24, 2021
• Primary Completion: February 28, 2023
• Study Completion: December 31, 2023
• Last Updated: July 15, 2022

Record last verified: 2022-06

Locations

FI (1)