NCT04386447: OsCOVID19

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

Withdrawn Phase 2 Last updated 14 January 2021

What this trial tests

Phase 2 trial testing Oxytocin in Covid-19. Withdrawn.

Timeline

1 September 2020

Primary endpoint
31 October 2020

31 December 2020

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria di Parma
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 September 2020
Primary completion	31 October 2020
Estimated completion	31 December 2020
Sites	3 locations across France, Italy

Drugs / interventions tested

• Oxytocin (OXYTOCIN) — full drug profile →
• Standard of Care

Conditions studied

• Covid-19 — all drugs for Covid-19 →
• Corona Virus Infection — all drugs for Corona Virus Infection →
• SARS-CoV 2 — all drugs for SARS-CoV 2 →

Sponsor

Azienda Ospedaliero-Universitaria di Parma — full company profile →

Who can join

18 and older, any sex, with Covid-19 or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
2. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
3. The Physiological Mechanisms of the Sex-Based Difference in Outcomes of COVID19 Infection.
   Wray S, Arrowsmith S. · · 2021 · cited 28× · PMID 33633588 · DOI 10.3389/fphys.2021.627260
4. An overview of Betacoronaviruses-associated severe respiratory syndromes, focusing on sex-type-specific immune responses.
   Rahimi G, Rahimi B, Panahi M, Abkhiz S, et al · · 2021 · cited 21× · PMID 33440306 · DOI 10.1016/j.intimp.2021.107365
5. Therapeutic dilemmas in addressing SARS-CoV-2 infection: Favipiravir versus Remdesivir.
   Negru PA, Radu AF, Vesa CM, Behl T, et al · · 2022 · cited 18× · PMID 35131656 · DOI 10.1016/j.biopha.2022.112700
6. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
   Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350
7. Potential of Endogenous Oxytocin in Endocrine Treatment and Prevention of COVID-19.
   Wang SC, Zhang F, Zhu H, Yang H, et al · · 2022 · cited 7× · PMID 35592777 · DOI 10.3389/fendo.2022.799521
8. Update on treatment and preventive interventions against COVID-19: an overview of potential pharmacological agents and vaccines.
   Xiao Y, Xu H, Guo W, Zhao Y, et al · · 2020 · cited 3× · PMID 34765999 · DOI 10.1186/s43556-020-00017-w