Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

Intervention 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 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. Study design Phase II, multicenter, open-label, experimental randomized controlled trial with an adaptive design, aiming to assess superiority of Oxytocin administration vs SoC. The adaptive design includes Stage 1, which aims to define the more active of the two considered OT doses, verify endpoints, the target population and the necessary sample size for the following Stage. Selection between the two considered doses (25 UI e 40 UI) will be based on the proportion of patients for which one of the conditions that make up the endpoint is recorded (see below). To this end, for each of the 2 dosages of the experimental agent, a single arm, single stage Fleming design will be applied. Patients enrolled in this Stage will be assigned by balanced randomization (1:1) to one of the two OT doses. The decisional algorithm requires that in a sample of 25 patients, at least 20 (80%) do not worsen to a critical stage (main endpoint) with respect to an expected 17 (68%) with only SOC. In Stage 2, patients in the experimental arm will receive the dose selected in Stage 1. The study, on two parallel groups, will use unbalanced randomization, because patients who received the selected dose in Stage 1 will be included in the experimental arm to achieve equal sample size between the two arms (60+60) for the analysis of final endpoints Sample size Stage 1 - sample is determined according to the single arm single stage Fleming design applied to each of the 2 investigated OT doses (25 and 40 UI). 25 patients for each dose are estimated necessary to demonstrate a statistically significant difference considering the one-tail test with an alpha probability of 10% and a statistical power of 80%. Stage 2 - determined using as comparison the test for proportions. From available data, it is assumed that during 14 days of hospitalization the proportion of patients in the SoC group who enters a critical stage (primary endpoint) is 30%, versus 12% in the experimental arm. Using a two-tail test, an alpha probability of 10% and a statistical power of 80%, was estimated that 60 patients per arm are necessary to demonstrate a statistically significant difference ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04386447
Study type Interventional
Source Azienda Ospedaliero-Universitaria di Parma
Contact
Status Withdrawn
Phase Phase 2
Start date September 1, 2020
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure