Covid-19Phase 2OsCOVID19NCT04386447
Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19
A Phase 2 study testing Oxytocin in people with Covid-19 and Corona Virus Infection, run by Azienda Ospedaliero-Universitaria di Parma at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Corona Virus Infection, SARS-CoV 2
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2020to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- Respiratory frequency ≥25/min, blood oxygen saturation (SaO2) < 95% in A-A, PaO2/FiO2 ratio < 300
- Hospital admission since less than 48 hours
- Signature of informed consent for study participation
Who cannot join
- MEWS score > 4
- Severe multiple organ failure
- Recent cardiomyopathy, unstable angina, acute myocardial infarction
- Severe kidney failure with glomerular filtration rate less than 30 ml/min or renal replacement therapy or peritoneal dialysis
- History of diabetes insipidus or severe hyponatremia (<128 mEq/L) or hypernatremia (>155 mEq/L)
- QT interval which in the opinion of the patient's treating physician contraindicates therapy with OT
Show all 12Show fewer
- State of shock
- Women who are pregnant or nursing
- Known intolerance or hypersensitivity to the drug or its excipients
- Treatment with antirejection agents
- Individuals with severe liver failure
- Patients enrolled in other clinical trials
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
Ospedale San Francesco
Nuoro
Azienda Ospedaliero Universitaria di Parma
Parma, PR, 43100
About this study
Official title: Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19
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
Read more
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
Read the detailed 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
- Conditions
- Covid-19, Corona Virus Infection, SARS-CoV 2
- Being tested
- Oxytocin, Standard of Care
- Keywords
- Covid-19, Oxytocin, Corona Virus Infection
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Oxytocin OT
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 CareDrug
Also called SOC
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 group | Role | What they receive |
|---|---|---|
| Oxytocin 40 UI + SOC | Experimental | In addition to standard treatment, patients in the experimental arm will receive intravenous OT with dilution of 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 Receives: Drug: Oxytocin |
| Oxytocin 25 UI + SOC | Experimental | In addition to standard treatment, patients in the experimental arm will receive intravenous OT with dilution of 25 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 Receives: Drug: Oxytocin |
| Standard of Care | Other | 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. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cases who during 14 exhibit one of the following conditions
Proportion of cases who during 14 days exhibit one of the following conditions (the most severe):
- respiratory failure that requires mechanical ventilation
- organ failure that requires intensive care monitoring and treatment
- death
Measured: 14 days
Secondary outcomes (1)
Mortality 28 days after randomization
Mortality 28 days after randomization
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: The study was not approved by the Italian Medicines Agency (AIFA).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma
- Responsible party
- Principal investigator, Tiziana Meschi, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Tiziana Meschi, MD,PhD, Principal investigator, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386447
- Sponsor's protocol ID
- OsCOVID19
- Acronym
- OsCOVID19
- Status last verified
- Jan 2021
- First submitted
- 12 May 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19
- ClinicalTrials.gov ID
- NCT04386447
- Acronym / sponsor ID
- OsCOVID19 / OsCOVID19
- Conditions
- Covid-19, Corona Virus Infection, SARS-CoV 2
- Keywords
- Covid-19, Oxytocin, Corona Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not approved by the Italian Medicines Agency (AIFA).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Collaborators
- University of Parma
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin 40 UI + SOC | Experimental | Drug: OxytocinIn addition to standard treatment, patients in the experimental arm will receive intravenous OT with dilution of 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 |
| Oxytocin 25 UI + SOC | Experimental | Drug: OxytocinIn addition to standard treatment, patients in the experimental arm will receive intravenous OT with dilution of 25 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 | Other | Drug: Standard of CareStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Respiratory frequency ≥25/min, blood oxygen saturation (SaO2) < 95% in A-A, PaO2/FiO2 ratio < 300
- Hospital admission since less than 48 hours
Key exclusion criteria (12 listed)
- MEWS score > 4
- Severe multiple organ failure
- Recent cardiomyopathy, unstable angina, acute myocardial infarction
- Severe kidney failure with glomerular filtration rate less than 30 ml/min or renal replacement therapy or peritoneal dialysis
- History of diabetes insipidus or severe hyponatremia (<128 mEq/L) or hypernatremia (>155 mEq/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Oxytocin OTIn 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 | Oxytocin 25 UI + SOC, Oxytocin 40 UI + SOC |
| Standard of CareAlso: SOCStandard 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. | Drug | Standard of Care |
Primary outcome
Proportion of cases who during 14 exhibit one of the following conditions
Time frame: 14 days
Proportion of cases who during 14 days exhibit one of the following conditions (the most severe): * respiratory failure that requires mechanical ventilation * organ failure that requires intensive care monitoring and treatment * death
1 secondary outcome
Mortality 28 days after randomization
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiziana Meschi, MD,PhD principal investigator
Azienda Ospedaliero-Universitaria di Parma
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Covid-19 and Corona Virus Infection, run by Azienda Ospedaliero-Universitaria di Parma at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases who during 14 exhibit one of the following conditions (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.