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| Column | Value |
|---|---|
| Trial registration number | NCT04978259 |
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Full text link
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
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First author
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
kari.tikkinen@helsinki.fi |
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Registration date
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
2021-07-27 |
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Recruitment status
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
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 |
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Exclusion criteria
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
- 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 |
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Number of arms
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Clinical Urology and Epidemiology Working Group |
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Inclusion age min
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Finland |
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Type of patients
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
No restriction on type of patients |
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Severity scale
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
0: No restriction on type of patients |
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Total sample size
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
202 |
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primary outcome
Last imported at : April 27, 2022, 3 a.m. Source : ClinicalTrials.gov |
EQ-5D-5L;EQ-VAS;Exertional dyspnea;Fatigue;Long-COVID symptoms;Recovering from COVID-19 infection |
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Notes
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |