Status:
WITHDRAWN
Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Collaborating Sponsors:
University of Parma
Conditions:
Covid-19
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young pers...
Detailed Description
Intervention In addition to standard treatment, patients in the experimental arm will receive intravenous OT with dilution of 25 UI or 40 UI OT in 500cc physiological solution NaCl 9%. OT will be admi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04386447
Start Date
September 1 2020
End Date
December 31 2020
Last Update
January 14 2021
Active Locations (3)
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1
CNRS
Lyon, France
2
Azienda Ospedaliero Universitaria di Parma
Parma, PR, Italy, 43100
3
Ospedale San Francesco
Nuoro, Italy