Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19

• Status: Withdrawn
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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 persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects.

Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim

To describe:

• Mortality 28 days after randomization

• Time to mechanical ventilation during the study

• Duration of dependency on oxygen supply

• Length of stay

• Temporal trend of clinical improvement (7-category ordinal scale)

• Safety analysis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma
• Collaborator: University of Parma
• Treatments: Oxytocin

Criteria

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:

• 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