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

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

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.

It had three arms (groups): Oxytocin 40 UI + SOC (experimental), Oxytocin 25 UI + SOC (experimental) and Standard of Care (other).

The registry classes the interventions as drug.

More on the Plan

Treatment duration will be 10 days Standard of Care (SoC).

To this end, for each of the 2 dosages of the experimental agent, a single arm, single stage Fleming design will be applied.

Stage 2 - determined using as comparison the test for proportions.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Hospital admission since less than 48 hours. Signature of informed consent for study participation.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: MEWS score \> 4; severe multiple organ failure; recent cardiomyopathy, unstable angina, acute myocardial infarction.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2020-09-01 with completion listed for 2020-10-31.

It ran at 3 sites in Italy (2) and France (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of cases who during 14 exhibit one of the following conditions (time frame: 14 days).

It also tracked 1 secondary outcome, for example Mortality 28 days after randomization.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.