COVID-19NIRS-COVNCT04392089
Effects of Cardiovascular and Pulmonary Optimization on Cerebral Oxygenation in COVID-19 Patients With Severe ARDS
An observational study of COVID-19 and Respiratory Failure, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of the present study is to examine whether cerebral oxygenation could be a more useful parameter than peripheral oxygen saturation to guide clinical titration of permissive hypoxemia in COVID-19 ARDS patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Respiratory Failure
- What is being tested?
- Masimo, LidCO
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 1 May 2021
- Phase
- Observational
- 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
Study population: Mechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation
Who may be able to join
- Age ≥ 18 years
- Verified COVID-19 infection (throat swab or tracheal aspirate positive for SARS-CoV-2)
- Severe ARDS according to Berlin definition
- Ventilator settings: Controlled IPPV, FiO2 > 0.70, PEEP > 10
- Norepinephrine infusion
- SVV < 10% measured by LiDCO
- RASS - 5
Who cannot join
- Any of the following contraindications to lung recruitment: pneumothorax, patients on ventilator > 1 week
- Patients with dark pigmented skin
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre Hospital
Copenhagen
Ana-Marija Hristovska, MD
About this study
Official title: Effects of Cardiovascular and Pulmonary Optimisation on Cerebral Oxygenation in COVID-19 Patients With Severe ARDS
The aim of the present study is to examine whether cerebral oxygenation could be a more useful parameter than peripheral oxygen saturation to guide clinical titration of permissive hypoxemia in COVID-19 ARDS patients
Read the detailed description
Mechanical ventilation is the cornerstone of supportive management for most ARDS patients to prevent life-threatening hypoxemia. Arterial oxygenation can be improved via ventilator by increasing fractional inspired oxygen (FiO2) and/or increasing mean airway pressure. When treating mechanically ventilated ARDS patients, the benefit of improved arterial oxygenation must be balanced against the potential risk of ventilator-induced lung injury (VILI), oxygen toxicity occurring with high FiO2 and development of right heart failure.
Arterial oxygen saturation target of 88-95 % and partial oxygen pressure (PaO2) target of 7.3-10.6 are advocated in the management of patients with ARDS. Surprisingly little randomized evidence exists to support these values and current recommendations are thus arbitrary and largely based on normal physiologic values.
Given the lack of evidence of strategies in oxygenating critically ill patients to an oxygen saturation and partial oxygen pressure that is generally accepted to be 'normal,' permissive hypoxemia may offer an alternative that has the potential to improve patient outcomes by avoiding unnecessary harm. Permissive hypoxemia is a concept in which a lower level of arterial oxygenation than usual is accepted in order to avoid the potentially detrimental effects of high fractional inspired oxygen and invasive mechanical ventilation with high pressures, while maintaining adequate oxygen delivery by optimizing cardiac output.
Pulse oximetry is a simple, non-invasive and universally used method to monitor peripheral oxygen saturation of hemoglobin in a variety of clinical settings. Pulse oximetry depends on pulsatile blood flow and only measures the oxyhemoglobin in arterial blood as it leaves the heart. However, this measure does not provide information regarding organ or tissue oxygenation, which reflects the important local balance between oxygen supply and demand.
Near-infrared spectroscopy (NIRS) allows for continuous measurement of regional tissue oxygenation which reflects perfusion status and enables clinicians to directly monitor fluctuations in real time. NIRS reflects the balance of oxygen that is delivered minus what is extracted at tissue level and is an indicator of the tissue oxygen uptake.
- Conditions
- COVID-19, Respiratory Failure
- Being tested
- Masimo, LidCO
- Keywords
- COVID-19, ARDS, NIRS, Saturation
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo, LidCODevice
- Near-infrared spectroscopy (NIRS), pulse oxymetry (saturation), continous hemoglobine, peripheral perfusion index (PPI) as measured with Massimo
- Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), stroke volume (SV), heart rate (HR), cardiac output (CO), systemic vascular resistance (SVR) as measured with LiDCO
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Mechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation Receives: Device: Masimo, LidCO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral oxygenation (ScO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization: Step 0 = Baseline, Step 1 = Derecruitment, Step 2 = Recruitment, Step 3 = Norepinephrine challenge, Step 4 = FiO2 increase, Step 5 = FiO2 decrease, Step 6 = Baseline 2
Measured: 1 hour
Secondary outcomes (38)
Changes in peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in systolic arterial pressure (SAP) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in mean arterial pressure (MAP) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in heart rate (HR) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in stroke volume (SV) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in cardiac output (CO) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in pH during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in PaO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in PaCO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in arterial saturation (SaO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in PvO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in PvCO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in lacatate during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Changes in muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and systemic arterial pressure (SAP) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and mean arterial pressure (MAP) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and stroke volume (SV) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and heart rate (HR) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and cardiac output (CO) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and pH during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and PaO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and PaCO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and arterial saturation (SaO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and PvO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and PvCO2 during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and lactate during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Association between cerebral oxygenation (ScO2) and muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization
Cardiovascular and pulmonary optimization as described above
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 May 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Marija Hristovska, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392089
- Sponsor's protocol ID
- H-20027818
- Acronym
- NIRS-COV
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiovascular and Pulmonary Optimisation on Cerebral Oxygenation in COVID-19 Patients With Severe ARDS
- ClinicalTrials.gov ID
- NCT04392089
- Acronym / sponsor ID
- NIRS-COV / H-20027818
- Conditions
- COVID-19, Respiratory Failure
- Keywords
- COVID-19, ARDS, NIRS, Saturation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 18 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.
The aim of the present study is to examine whether cerebral oxygenation could be a more useful parameter than peripheral oxygen saturation to guide clinical titration of permissive hypoxemia in COVID-19 ARDS patients
Detailed description
Mechanical ventilation is the cornerstone of supportive management for most ARDS patients to prevent life-threatening hypoxemia. Arterial oxygenation can be improved via ventilator by increasing fractional inspired oxygen (FiO2) and/or increasing mean airway pressure. When treating mechanically ventilated ARDS patients, the benefit of improved arterial oxygenation must be balanced against the potential risk of ventilator-induced lung injury (VILI), oxygen toxicity occurring with high FiO2 and development of right heart failure.
Arterial oxygen saturation target of 88-95 % and partial oxygen pressure (PaO2) target of 7.3-10.6 are advocated in the management of patients with ARDS. Surprisingly little randomized evidence exists to support these values and current recommendations are thus arbitrary and largely based on normal physiologic values.
Given the lack of evidence of strategies in oxygenating critically ill patients to an oxygen saturation and partial oxygen pressure that is generally accepted to be 'normal,' permissive hypoxemia may offer an alternative that has the potential to improve patient outcomes by avoiding unnecessary harm. Permissive hypoxemia is a concept in which a lower level of arterial oxygenation than usual is accepted in order to avoid the potentially detrimental effects of high fractional inspired oxygen and invasive mechanical ventilation with high pressures, while maintaining adequate oxygen delivery by optimizing cardiac output.
Pulse oximetry is a simple, non-invasive and universally used method to monitor peripheral oxygen saturation of hemoglobin in a variety of clinical settings. Pulse oximetry depends on pulsatile blood flow and only measures the oxyhemoglobin in arterial blood as it leaves the heart. However, this measure does not provide information regarding organ or tissue oxygenation, which reflects the important local balance between oxygen supply and demand.
Near-infrared spectroscopy (NIRS) allows for continuous measurement of regional tissue oxygenation which reflects perfusion status and enables clinicians to directly monitor fluctuations in real time. NIRS reflects the balance of oxygen that is delivered minus what is extracted at tissue level and is an indicator of the tissue oxygen uptake.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Device: Masimo, LidCOMechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated COVID-19 patients with severe ARDS included within 3 days from time of intubation
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Verified COVID-19 infection (throat swab or tracheal aspirate positive for SARS-CoV-2)
- Severe ARDS according to Berlin definition
- Ventilator settings: Controlled IPPV, FiO2 > 0.70, PEEP > 10
- Norepinephrine infusion
Key exclusion criteria (2 listed)
- Any of the following contraindications to lung recruitment: pneumothorax, patients on ventilator > 1 week
- Patients with dark pigmented skin
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 |
|---|---|---|
| Masimo, LidCO* Near-infrared spectroscopy (NIRS), pulse oxymetry (saturation), continous hemoglobine, peripheral perfusion index (PPI) as measured with Massimo * Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), stroke volume (SV), heart rate (HR), cardiac output (CO), systemic vascular resistance (SVR) as measured with LiDCO | Device | COVID-19 |
Primary outcome
Changes in cerebral oxygenation (ScO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Cardiovascular and pulmonary optimization: Step 0 = Baseline, Step 1 = Derecruitment, Step 2 = Recruitment, Step 3 = Norepinephrine challenge, Step 4 = FiO2 increase, Step 5 = FiO2 decrease, Step 6 = Baseline 2
38 secondary outcomes
Changes in peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in systolic arterial pressure (SAP) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in mean arterial pressure (MAP) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in heart rate (HR) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in stroke volume (SV) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in cardiac output (CO) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in pH during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in PaO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in PaCO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in arterial saturation (SaO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in PvO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in PvCO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in lacatate during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Changes in muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and peripheral oxygen saturation (SatO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and systemic arterial pressure (SAP) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and diastolic arterial pressure (DAP) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and mean arterial pressure (MAP) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and stroke volume (SV) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and heart rate (HR) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and cardiac output (CO) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and systemic vascular resistance (SVR) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and peripheral perfussion index (PPI) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and pH during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and PaO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and PaCO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and arterial saturation (SaO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and PvO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and PvCO2 during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and mixed venous saturation (SvO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and lactate during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and hemoglobine concentration (Hb) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Association between cerebral oxygenation (ScO2) and muscular oxygenation (SmO2) during cardiovascular and pulmonary optimization
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Respiratory Failure, run by Hvidovre University Hospital at 1 site in Denmark.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana-Marija Hristovska, MD, Ph.d.-student (+4538625532, ana-marija.hristovska.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cerebral oxygenation (ScO2) during cardiovascular and pulmonary optimization (time frame: 1 hour). 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 18 May 2020.