NCT04978259

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

Status unknown Phase 4 Last updated 15 July 2022

What this trial tests

Phase 4 trial testing Remdesivir in Covid19 in 202 participants. Status unknown.

Timeline

24 July 2021

Primary endpoint
28 February 2023

31 December 2023

Quick facts

Lead sponsor	Clinical Urology and Epidemiology Working Group
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	202
Start date	24 July 2021
Primary completion	28 February 2023
Estimated completion	31 December 2023
Sites	1 location across Finland

Drugs / interventions tested

• Remdesivir (remdesivir) — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Clinical Urology and Epidemiology Working Group

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic strategies for COVID-19: progress and lessons learned.
   Li G, Hilgenfeld R, Whitley R, De Clercq E. · · 2023 · cited 455× · PMID 37076602 · DOI 10.1038/s41573-023-00672-y
2. Long COVID and its Management.
   Koc HC, Xiao J, Liu W, Li Y, et al · · 2022 · cited 153× · PMID 35874958 · DOI 10.7150/ijbs.75056
3. The long-term health outcomes, pathophysiological mechanisms and multidisciplinary management of long COVID.
   Li J, Zhou Y, Ma J, Zhang Q, et al · · 2023 · cited 91× · PMID 37907497 · DOI 10.1038/s41392-023-01640-z
4. Therapeutic trials for long COVID-19: A call to action from the interventions taskforce of the RECOVER initiative.
   Bonilla H, Peluso MJ, Rodgers K, Aberg JA, et al · · 2023 · cited 72× · PMID 36969241 · DOI 10.3389/fimmu.2023.1129459
5. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
6. Remdesivir for the treatment of COVID-19.
   Grundeis F, Ansems K, Dahms K, Thieme V, et al · · 2023 · cited 55× · PMID 36695483 · DOI 10.1002/14651858.cd014962.pub2
7. Clinical trials on the pharmacological treatment of long COVID: A systematic review.
   Chee YJ, Fan BE, Young BE, Dalan R, et al · · 2023 · cited 55× · PMID 36349400 · DOI 10.1002/jmv.28289
8. Effect of remdesivir post hospitalization for COVID-19 infection from the randomized SOLIDARITY Finland trial.
   Nevalainen OPO, Horstia S, Laakkonen S, Rutanen J, et al · · 2022 · cited 49× · PMID 36257950 · DOI 10.1038/s41467-022-33825-5