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Trial - NCT04392531


Column Value
Trial registration number NCT04392531
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04392531

First author
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

Olga Sanchez Pernaute, MD, PhD

Contact
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

osanchez@fjd.es

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-19

Recruitment status
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

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

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: women and men over 18 years old clinical diagnosis of covid19 infection (to be subsequently confirmed by pcr or specific igm isotype ac and with entry criteria according to the protocol of action (see annex 2) acceptance and signing of the consent for the study after having received the appropriate information. exclusion criteria known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components. contraindication for the use of any of the medications included (*) csa: ir est 4.5 (fg <30 ml / min according to the cockcroft-gault formula) antimalarials (chloroquine, hydroxychloroquine): retinopathy, myasthenia gravis. lopinavir / ritonavir: severe liver failure remdesivir, darunovir-ritonavir doxycycline, azithromycin kidney failure (stages 4 and 5: gfr <30 ml / min according to the cockcroft-gault formula). decompensated liver disease (child-pugh stages b or c) or chronic infection with virus b pregnancy or lactation age over 75 years participants in another clinical trial with medication in the 28 days prior to the start of recruitment. participation in observational studies is allowed. refusal to participate patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions at the investigator's discretion, the patient's inability to understand or comply with the study procedures

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

111

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severity Category

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 283, "treatment_name": "Ciclosporin", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]