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Trial - NCT04386447


Column Value
Trial registration number NCT04386447
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04386447

First author
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Tiziana Meschi, MD, PhD

Contact
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

tiziana.meschi@unipr.it

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

2020-05-13

Recruitment status
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

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

Adaptive

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

Open label

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

inclusion criteria: - age > 18 years - diagnosis of pneumonia caused by covid-19 - respiratory and/or systemic symptoms and initial mild respiratory failure and with objective signs of lung involvement - respiratory frequency ≥25/min, blood oxygen saturation (sao2) < 95% in a-a, pao2/fio2 ratio < 300 - hospital admission since less than 48 hours - signature of informed consent for study participation

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

- mews score > 4 - severe multiple organ failure - recent cardiomyopathy, unstable angina, acute myocardial infarction - severe kidney failure with glomerular filtration rate less than 30 ml/min or renal replacement therapy or peritoneal dialysis - history of diabetes insipidus or severe hyponatremia (<128 meq/l) or hypernatremia (>155 meq/l) - qt interval which in the opinion of the patient's treating physician contraindicates therapy with ot - state of shock - women who are pregnant or nursing - known intolerance or hypersensitivity to the drug or its excipients - treatment with antirejection agents - individuals with severe liver failure - patients enrolled in other clinical trials

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

Azienda Ospedaliero-Universitaria di Parma

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

None

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

France;Italy

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

Severe disease at enrollment

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

6: Severe disease at enrollment

Total sample size
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0

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

Proportion of cases who during 14 exhibit one of the following conditions

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 2

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

[{"arm_notes": "25 UI ", "treatment_id": 949, "treatment_name": "Oxytocin", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "40 UI ", "treatment_id": 949, "treatment_name": "Oxytocin", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}]