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Withdrawn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:
Participant gender:
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