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

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)

Conditions

• Covid19

Interventions

DRUG

Remdesivir

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

Sponsors & Collaborators

• University of Helsinki

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Hyvinkää Hospital

  collaborator OTHER

• Kanta-Häme Central Hospital

  collaborator OTHER_GOV

• Kuopio University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Porvoo Hospital

  collaborator UNKNOWN

• Seinajoki Central Hospital

  collaborator OTHER

• Mikkeli Central Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Clinical Urology and Epidemiology Working Group

  lead OTHER_GOV

Principal Investigators

• Kari AO Tikkinen, MD PhD · University of Helsinki

• Olli Nevalainen, MD PhD · University of Helsinki

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-24

Primary Completion

2023-02-28

Completion

2023-12-31

Countries

• Finland

Study Locations