SARS-CoV 2Phase 1BATITNCT04401410
Anti-SARS Cov-2 T Cell Infusions for COVID 19
A Phase 1 study testing Dose Finding Phase (MTD), Partially HLA-matched SARS-CoVSTs and Routine care (no SARS-CoVSTs) in people with SARS-CoV 2 and Viral Infection, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2, Viral Infection, COVID 19
- What is being tested?
- Dose Finding Phase (MTD), Partially HLA-matched SARS-CoVSTs and Routine care (no SARS-CoVSTs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2020to 12 Oct 2021
- Phase
- Phase 1
- 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
- SARS-CoV-2 infection confirmed by polymerase chain reaction assay (PCR) from a nasopharyngeal swab or other accepted specimen type. (If testing was performed ≥ 5 days before enrollment, this must be repeated and accept only if positive again). Date of COVID test must be ≤ 5 days prior to infusion.
- Currently hospitalized adult patient (≥ 18 years of age) requiring medical care for COVID19
- Peripheral oxygen saturation (SpO2) ≥ 92% on room air
- Hgb ≥ 7.0 gm/dl
- Negative pregnancy test (if applicable)
- Patient or parent/guardian capable of providing informed consent (may be obtained electronically)
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- Evidence of pulmonary infiltrates on chest imaging. Any chest imaging findings which would be consistent with COVID19 would qualify (Eg: ground glass opacities, multifocal infiltrates etc.)
- High risk of requiring mechanical ventilation as defined by at least two of the following:
- Age ≥ 60 years of age
- Age ≥ 75 years of age (counts as meeting two criteria)
- Hypertension (HTN)
- Chronic cardiovascular disease other than HTN (eg: Coronary artery disease, congestive heart failure or cardiomyopathies).
- Diabetes Mellitus
- Obesity (BMI ≥ 30)
- Obesity (BMI ≥ 40, counts as meeting two criteria)
- Active cancer diagnosis or ongoing (within 3 months) cytotoxic chemo/ radio-therapy for a cancer
- Post-hematopoeitic stem cell or solid organ transplantation status
- Immunodeficiency states including HIV infection on antiretroviral therapy (except those listed as exclusion criteria #1, #7 and #10) as determined by the treating physician (eg: receiving immunosuppressive therapy like rituximab or congenital immunodeficiency syndromes, prior treatment with chemotherapy greater than 3 months ago but per investigators discretion could have lingering effects on the immune system, eg: chemotherapy regimens for lymphomas, ALL or AML etc.)
- Chronic obstructive pulmonary disease (COPD)
- Current everyday smoker
- Chronic kidney disease (eGFR < 30 mL/min/1.73 m2 )
- Bronchial asthma (on active treatment prior to admission, eg. Use of rescue inhalers or inhaled corticosteroids or other treatments to prevent/treat attacks).
Who cannot join
- Received Anti-thymocyte globulin (ATG), Campath or other T cell immunosuppressive monoclonal antibodies in the 28 days prior to screening for enrollment
- Requiring mechanical ventilation at time of T cell infusion
- Alanine aminotransferase or aspartate aminotransferase greater than 5 x upper limit of normal
- If previously undergone an allogeneic hematopoietic stem cell transplant and have evidence of active acute GVHD greater than or equal to grade 2
- Uncontrolled relapse of malignancy
- Requiring vasopressors
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- Known history of autoimmune disease except prior thyroiditis
- Is not suitable at the discretion of the treating physician
- Patients on greater than 6mg/day of dexamethasone (IV) or equivalent
- Greater than grade 1 CRS per American Society for Transplantation and Cellular Therapy (ASTCT) criteria
- Patients should not be enrolled on any other interventional clinical trials for COVID19. Patients may receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other FDA-EUA approved products and thromboprophylaxis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation.
The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.
Read the detailed description
The first part of this study is to identify the maximum tolerated dose (MTD) of allogeneic SARS-CoV2-specific T cells (SARS-CoVSTs) for patients with COVID19 with high risk of progression to mechanical ventilation.
The 3 dose levels (DL) are:
DL1: 1x10^7 cells (flat dose) DL2: 2x10^7 cells (flat dose) DL3: 4x10^7 cells (flat dose)
Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level.
After the dose finding phase is complete and the MTD established, a randomized trial will be conducted. Patient will be randomized 1:1 using the permuted block method with a block size of 4 (2 in the treatment arm and 2 in the control arm) to receive treatment with SARS-CoVSTs or routine treatment per institutional standards.
All enrolled patients will undergo the following evaluations:
- Physical exam and history including height and weight
- SARS-CoV-2 test
- Blood tests
- Chest X-ray or chest CT Scan if not already done in the past 48 hours.
- A urine pregnancy test, when applicable
Patients randomized to receive SARS-CoVSTs will be pre-medicated with Benadryl and Tylenol. The cells will be thawed and given through an intravenous line. Patients will be monitored for infusion side effects for up to 14 days or until infusion side effects have completely resolved, whichever is longer.
Blood will be drawn before the infusion and then up to daily for 14 days or until the patient is discharged from the hospital. Optional blood samples will be drawn at 2, 3 and 6 months after infusion. Study participation will last 6 months after the date of infusion.
- Conditions
- SARS-CoV 2, Viral Infection, COVID 19
- Being tested
- Dose Finding Phase (MTD), Partially HLA-matched SARS-CoVSTs, Routine care (no SARS-CoVSTs)
- Keywords
- COVID 19, SARS-CoV 2, Viral infection, Multivirus T cell
- Medical subject headings
- Virus Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Finding Phase (MTD)Biological
Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level.
Partially HLA-matched SARS-CoVSTsBiological
Infusion of SARS-CoVSTs at the MTD level as determined in the Dose Finding Phase
Routine care (no SARS-CoVSTs)Other
Patients receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other FDA-EUA approved products and thromboprophylaxis).
| Study group | Role | What they receive |
|---|---|---|
| Dose Finding Phase | Experimental | This phase is designed to evaluate the maximum tolerated dose (MTD) of partially HLA-matched SARS-CoVSTs administered to hospitalized COVID19 patients with high risk of progression to mechanical ventilation.
The dose finding phase is a standard 3+3 safety study design. The 3 dose levels are:
DL1: 1x10^7 cells (flat dose) DL2: 2x10^7 cells (flat dose) DL3: 4x10^7 cells (flat dose) Receives: Biological: Dose Finding Phase (MTD) |
| Randomized Pilot - SARS-CoVSTs | Experimental | Partially HLA-matched Virus Specific T cells (VSTs) will be given by intravenous injection. Receives: Biological: Partially HLA-matched SARS-CoVSTs |
| Randomized Pilot - Routine Care | Active comparator | Hospitalized patients with COVID-19 will be treated per current institutional guidelines. Receives: Other: Routine care (no SARS-CoVSTs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Phase: Rate of Dose Limiting Toxicities by CTCAE 5.0 [14 days post infusion]
Defined as the proportion of subjects with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment. A dose limiting toxicity is defined as any acute GvHD (> grade 2), grade ≥3 CRS or ICANS, grade ≥3 hematologic toxicity or grade ≥3 non-hematologic adverse events related to the T cell product within 14 days of the VST infusion and that are not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Measured: 14 days post infusion
Randomized Trial: Rate of Clinical Response as assessed by the World Health Organization (WHO) Ordinal Scale [7 days post-randomization or hospital discharge]
Clinical Response rate is defined as the proportion of subjects reporting an increase in 2 or more points on the WHO Ordinal Scale. [Scored on a scale from 0 to 8; where 0 = Uninfected and 8 =Dead] or until patient is discharged.
Measured: 7 Days post-randomization or at time of hospital discharge
Secondary outcomes (1)
Randomized Trial: Rate of Treatment-related adverse events (tAE) by CTCAE 5.0 [14 days post-randomization]
Defined as the proportion of subjects with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment. Treatment-related adverse events (tAE) are defined as any acute GvHD (> grade 2), grade ≥3 CRS or ICANS, grade ≥3 hematologic toxicity or grade ≥3 non-hematologic adverse events related to the T cell product within 14 days of the VST infusion and that are not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Measured: 14 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start4 Nov 2020
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Why it stopped: Due to trial's eligibility criteria and the low census of hospitalized COVID-19 patients meeting eligibility criteria, the Sponsor will be unable to enroll a meaningful number of patients in this single-center trial in a reasonable time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, AlloVir, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Premal Lulla, Baylor College of Medicine
- Investigators
- Premal Lulla, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401410
- Sponsor's protocol ID
- H-47739 BAT IT
- Acronym
- BATIT
- Status last verified
- Dec 2022
- First submitted
- 21 May 2020
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vasileiou S, Hill L, Kuvalekar M, Workineh AG, Watanabe A, Velazquez Y, Lulla S, Mooney K, Lapteva N, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Eagar TN, Carrum G, Grimes KA, Leen AM, Lulla P. Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients. Haematologica. 2023 Jul 1;108(7):1840-1850. doi: 10.3324/haematol.2022.281946.
PubMed 36373249
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19
- ClinicalTrials.gov ID
- NCT04401410
- Acronym / sponsor ID
- BATIT / H-47739 BAT IT
- Conditions
- SARS-CoV 2, Viral Infection, COVID 19
- Keywords
- COVID 19, SARS-CoV 2, Viral infection, Multivirus T cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to trial's eligibility criteria and the low census of hospitalized COVID-19 patients meeting eligibility criteria, the Sponsor will be unable to enroll a meaningful number of patients in this single-center trial in a reasonable time frame.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, AlloVir, The Methodist Hospital Research Institute
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 26 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.
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation.
The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.
Detailed description
The first part of this study is to identify the maximum tolerated dose (MTD) of allogeneic SARS-CoV2-specific T cells (SARS-CoVSTs) for patients with COVID19 with high risk of progression to mechanical ventilation.
The 3 dose levels (DL) are:
DL1: 1x10^7 cells (flat dose) DL2: 2x10^7 cells (flat dose) DL3: 4x10^7 cells (flat dose)
Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level.
After the dose finding phase is complete and the MTD established, a randomized trial will be conducted. Patient will be randomized 1:1 using the permuted block method with a block size of 4 (2 in the treatment arm and 2 in the control arm) to receive treatment with SARS-CoVSTs or routine treatment per institutional standards.
All enrolled patients will undergo the following evaluations:
- Physical exam and history including height and weight
- SARS-CoV-2 test
- Blood tests
- Chest X-ray or chest CT Scan if not already done in the past 48 hours.
- A urine pregnancy test, when applicable
Patients randomized to receive SARS-CoVSTs will be pre-medicated with Benadryl and Tylenol. The cells will be thawed and given through an intravenous line. Patients will be monitored for infusion side effects for up to 14 days or until infusion side effects have completely resolved, whichever is longer.
Blood will be drawn before the infusion and then up to daily for 14 days or until the patient is discharged from the hospital. Optional blood samples will be drawn at 2, 3 and 6 months after infusion. Study participation will last 6 months after the date of infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Finding Phase | Experimental | Biological: Dose Finding Phase (MTD)This phase is designed to evaluate the maximum tolerated dose (MTD) of partially HLA-matched SARS-CoVSTs administered to hospitalized COVID19 patients with high risk of progression to mechanical ventilation. The dose finding phase is a standard 3+3 safety study design. The 3 dose levels are: DL1: 1x10^7 cells (flat dose) DL2: 2x10^7 cells (flat dose) DL3: 4x10^7 cells (flat dose) |
| Randomized Pilot - SARS-CoVSTs | Experimental | Biological: Partially HLA-matched SARS-CoVSTsPartially HLA-matched Virus Specific T cells (VSTs) will be given by intravenous injection. |
| Randomized Pilot - Routine Care | Active comparator | Other: Routine care (no SARS-CoVSTs)Hospitalized patients with COVID-19 will be treated per current institutional guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- SARS-CoV-2 infection confirmed by polymerase chain reaction assay (PCR) from a nasopharyngeal swab or other accepted specimen type. (If testing was performed ≥ 5 days before enrollment, this must be repeated and accept only if positive again). Date of COVID test must be ≤ 5 days prior to infusion.
- Currently hospitalized adult patient (≥ 18 years of age) requiring medical care for COVID19
- Peripheral oxygen saturation (SpO2) ≥ 92% on room air
- Hgb ≥ 7.0 gm/dl
- Negative pregnancy test (if applicable)
Key exclusion criteria (11 listed)
- Received Anti-thymocyte globulin (ATG), Campath or other T cell immunosuppressive monoclonal antibodies in the 28 days prior to screening for enrollment
- Requiring mechanical ventilation at time of T cell infusion
- Alanine aminotransferase or aspartate aminotransferase greater than 5 x upper limit of normal
- If previously undergone an allogeneic hematopoietic stem cell transplant and have evidence of active acute GVHD greater than or equal to grade 2
- Uncontrolled relapse of malignancy
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 |
|---|---|---|
| Dose Finding Phase (MTD)Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level. | Biological | Dose Finding Phase |
| Partially HLA-matched SARS-CoVSTsInfusion of SARS-CoVSTs at the MTD level as determined in the Dose Finding Phase | Biological | Randomized Pilot - SARS-CoVSTs |
| Routine care (no SARS-CoVSTs)Patients receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other FDA-EUA approved products and thromboprophylaxis). | Other | Randomized Pilot - Routine Care |
Primary outcome
Dose Escalation Phase: Rate of Dose Limiting Toxicities by CTCAE 5.0 [14 days post infusion]
Time frame: 14 days post infusion
Defined as the proportion of subjects with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment. A dose limiting toxicity is defined as any acute GvHD (> grade 2), grade ≥3 CRS or ICANS, grade ≥3 hematologic toxicity or grade ≥3 non-hematologic adverse events related to the T cell product within 14 days of the VST infusion and that are not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Randomized Trial: Rate of Clinical Response as assessed by the World Health Organization (WHO) Ordinal Scale [7 days post-randomization or hospital discharge]
Time frame: 7 Days post-randomization or at time of hospital discharge
Clinical Response rate is defined as the proportion of subjects reporting an increase in 2 or more points on the WHO Ordinal Scale. [Scored on a scale from 0 to 8; where 0 = Uninfected and 8 =Dead] or until patient is discharged.
1 secondary outcome
Randomized Trial: Rate of Treatment-related adverse events (tAE) by CTCAE 5.0 [14 days post-randomization]
Time frame: 14 days post-randomization
Results and safety
The study was stopped early (reason given: Due to trial's eligibility criteria and the low census of hospitalized COVID-19 patients meeting eligibility criteria, the Sponsor will be unable to enroll a meaningful number of patients in this single-center trial in a reasonable time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Derived from this study: PubMed 36373249Vasileiou S, Hill L, Kuvalekar M, Workineh AG, Watanabe A, Velazquez Y, Lulla S, Mooney K, Lapteva N, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Eagar TN, Carrum G, Grimes KA, Leen AM, Lulla P. Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients. Haematologica. 2023 Jul 1;108(7):1840-1850. doi: 10.3324/haematol.2022.281946.
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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.
Premal Lulla principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose Finding Phase (MTD), Partially HLA-matched SARS-CoVSTs and Routine care (no SARS-CoVSTs) in people with SARS-CoV 2 and Viral Infection, run by Baylor College of Medicine at 1 site in United States.
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 22 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Dec 2022. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Due to trial's eligibility criteria and the low census of hospitalized COVID-19 patients meeting eligibility criteria, the Sponsor will be unable to enroll a meaningful number of patients in this single-center trial in a reasonable time frame.). Results are not available in the source record.
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?
Dose Escalation Phase: Rate of Dose Limiting Toxicities by CTCAE 5.0 [14 days post infusion] (time frame: 14 days post infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04401410, which also lists 1 linked publication.
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 19 Dec 2022.