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

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

Conditions

• Covid-19
• Corona Virus Infection
• SARS-CoV 2

Interventions

DRUG

Oxytocin

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 administered with continuous pump infusion with 62,5 ml/h. The clinician will have the option to decrease infusion speed based on significant variations in arterial pressure, otherwise, the total 25 UI or 40 UI amount will be infused in 8 hours. Treatment duration will be 10 days

DRUG

Standard of Care

Standard of Care (SoC). Standard of Care will comply with the indications of the Emilia-Romagna Region for the treatment of covid-19, and will include the following: * Oxygen supply or non-invasive ventilation to target peripheral blood saturation \> 94% * Hydroxychloroquine 200mg b.i.d w/o an initial 1-2 days loading dose of 400 mg bid for 1-2 days (the dose may be reduced in patients with advanced CKD according to local protocols) or remdesivir 200 mg in.v on day 1, followed by a 100 mg q.d. * Antiretroviral therapy (usually for 5 days) with lopinavir / ritonavir or darunavir / cobicistat is permitted * Azithromycin 500 mg q.d., usually for 5 days, is permitted in patients with suspected bacterial superinfection, paying particular attention to safety, considering reports of risk of adverse events in association with hydroxychloroquine * Prophylaxis for deep vein thrombosis * Steroids are not routinely recommended but may be considered in selected patients.

Sponsors & Collaborators

• University of Parma

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Parma

  lead OTHER

Principal Investigators

• Tiziana Meschi, MD,PhD · Azienda Ospedaliero-Universitaria di Parma

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2020-10-31

Completion

2020-12-31

Countries

• France
• Italy

Study Locations