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Trial - NCT05220280


Column Value
Trial registration number NCT05220280
Full text link
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05220280

First author
Last imported at : May 6, 2022, 5 a.m.
Source : ClinicalTrials.gov

Kari AO Tikkinen, MD PhD

Contact
Last imported at : May 6, 2022, 5 a.m.
Source : ClinicalTrials.gov

kari.tikkinen@helsinki.fi

Registration date
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

2022-02-02

Recruitment status
Last imported at : May 6, 2022, 5 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: adult patients, 18 years and above sars-2-cov-2 infection, laboratory-confirmed admission to the hospital ward or icu written informed consent prior to initiation of the study or a close relative/legal representative provides written informed consent prior to initiation of the study according to the presumed will of the patient when the patient is unable to give consent herself/himself. no anticipated transfer within 72 hours to a non-study hospital

Exclusion criteria
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

estimated life expectancy under three months due to severe comorbidity asat/alat-ratio over five-fold upper limit acute myocardial infarction or unstable angina pectoris breast feeding or pregnancy any reason why, in the opinion of the investigators, the patient should not participate patient participates in a potentially confounding drug or device trial during the course of the study already receiving any of the study drugs severe renal failure (egfr < 30 ml/min)

Number of arms
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Clinical Urology and Epidemiology Working Group

Inclusion age min
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 6, 2022, 5 a.m.
Source : ClinicalTrials.gov

Finland

Type of patients
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

400

primary outcome
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Health-related quality of life;Health-related quality of life;Health-related quality of life;Long-COVID symptoms;Long-COVID symptoms;Long-COVID symptoms

Notes
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]