COVID-19 PneumoniaPhase 2I-TOMICNCT04415151
Tofacitinib for Treatment of Moderate COVID-19
A Phase 2 study testing Tofacitinib 10 mg in people with COVID-19 Pneumonia, run by Yale University at 1 site in United States.
Trial summary
The purpose of this randomized, double blinded, placebo controlled study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Tofacitinib 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2020to 28 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercially available or public health assay prior to Day 1.
- Participants with evidence of pneumonia assessed by radiographic imaging (chest x ray or chest CT scan) AND Requiring ≥ 3L O2 OR ≥ 2L O2 and hsCRP > 70 mg/L
- Participants who are hospitalized and receiving supportive care for COVID-19.
- Participant (or legally authorized representative/surrogate) capable of giving signed informed consent.
Who cannot join
- Medical Conditions:
- Require mechanical ventilation or ECMO on Day 1 at the time of randomization.
- Have current, or history of, venous thromboembolism (deep vein thrombosis or pulmonary embolism).
- Have a personal or first-degree family history of blood clotting disorders.
- Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (eg, azathioprine, cyclosporine).
- Participants with any current malignancy or lymphoproliferative disorders that requires active treatment
Show all 35Show fewer
- Females of child bearing potential who are pregnant or breastfeeding
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Anticipated survival < 72 hours as assessed by the Investigator.
- Infection History:
- Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19) including but not limited to:
- Secondary bacterial pneumonia;
- Active herpes zoster infection;
- Known active tuberculosis or history of inadequately treated tuberculosis;
- Known HBV, HCV, or HIV.
- Prior/Concomitant Therapy:
- Have received any of the following treatment regimens specified in the timeframes outlined below:
- Within 4 weeks prior to the first dose of study intervention:
- Prior treatment with any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (eg, tocilizumab) or IL-1 inhibitors (eg, anakinra);
- Prior treatment with any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer.
- Within 48 hours prior to the first dose of study intervention:
- o Treatment with herbal supplements.
- Received >/= 20 mg/day of prednisone or equivalent for >/=14 consecutive days in the 4 weeks prior to screening.
- Diagnostic Assessments:
- Severe hepatic impairment, defined as Child-Pugh class C.
- Severe anemia (hemoglobin <8 g/dL).
- ANY of the following abnormalities in clinical laboratory tests at screening, confirmed by a single repeat, if deemed necessary:
- WBC <1000/mm3
- Absolute lymphocyte count <500 cells/mm3;
- Absolute neutrophil count <1000 cells/mm3.
- Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal;
- Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m2);
- Other Exclusions:
- Known allergy to tofacitinib.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Health System
New Haven, Connecticut, 06511
About this study
Official title: Investigation of Tofacitinib to Mitigate the Impact of COVID-19 (I-TOMIC) in Moderate SARS-CoV-2 (MODERATE I-TOMIC)
The purpose of this randomized, double blinded, placebo controlled study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation.
Read the detailed description
The purpose of this randomized, double blinded, placebo controlled Phase 2b study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) male and female patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation (see Inclusion criteria). Sixty patients will be recruited to receive tofacitinib or placebo in addition to standard of care (SOC) in a 1:1 ratio.
Subjects will be screened during hospitalization. Patients with confirmed SARS-CoV-2 infection, and meeting all other Inclusion and Exclusion criteria, will be randomized to either treatment with tofacitinib or placebo in addition to SOC during hospitalization (dose adjusted, if required), with the exception of pre-specified immunomodulatory agents (as documented in the inclusion/exclusion criteria). Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by need for supplementary oxygen), and will continue to be administered at 5 mg PO BID for a total duration of therapy of 14 days; follow-up off tofacitinib will continue up to Day 90. We anticipate completion of subject recruitment in 6 months.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Tofacitinib 10 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 10 mgDrug
Tofacitinib will be administered in a dose of 10 mg twice daily by mouth (PO BID) until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.
PlaceboDrug
Matching placebo tablets will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Experimental | Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days. Receives: Drug: Tofacitinib 10 mg |
| Placebo | Placebo comparator | Matching placebo will be administered. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Severity
The primary objective of this study is to determine whether tofacitinib improves the clinical outcomes of patients with moderate SARS-CoV-2 infection as determined by the primary outcome measure: Proportion of subjects alive and not needing any form of mechanical ventilation, high flow oxygen, or ECMO by day 14.
Measured: 14 days
Secondary outcomes (15)
Clinical Improvement (Last Measure)
Clinical improvement as measured by NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities) at day 14.
The scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities.
Updated at the time of results entry, presented are the last clinical status for participants in the study (high scores are better outcomes).
Measured: Up to 14 days
Clinical Improvement (Improved Score)
Clinical improvement as measured by NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities) (days 3 through day 14):
The scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities.
Added at the time of results entry: this outcome presents those that improved at least 2 or more levels on the clinical scale (high scores are better outcomes).
Measured: Up to 14 days
Time to Recovery
Time to recovery [ Time Frame: Day 1 through Day 14] (Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale:
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities)
Measured: Up to 14 days
Time to Clinical Improvement
Time to clinical improvement (defined as a 2-point increase on the NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities).
The scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities.
Updated at the time of results entry, the follow up time frame was adjusted.
Measured: Up to 14 days
Clinical Status
Clinical status on the NIAID 8-point ordinal scale at day 30
The scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities.
Updated at the time of results entry, the follow up time frame was adjusted.
Measured: Up to 28 Days
Clinical Status
Clinical status on the NIAID 8-point ordinal scale at day 60
The scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities.
Measured: 60 Days
Clinical Status
Clinical status on the NIAID 8-point ordinal scale at day 90
The scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities.
Measured: 90 Days
Mortality
Mortality rate at day 30 (28 Days- updated at time of results entry). Presented are a count of those participants that expired (all-cause) through the 28 day follow up. This outcome includes counts of those that expired during the study period (see adverse events All-Cause Mortality).
Measured: Up to 28 Days
Mortality
Mortality rate at day 60 (updated at time of results entry). Presented are a count of those participants that expired (all-cause) through the 60 day follow up. This outcome includes counts of those that expired during the study period (see adverse events All Cause Mortality).
Measured: 60 Days
Mortality
Mortality rate at day 90. Presented are a count of those participants that expired (all-cause) through the 90 day follow up. This outcome includes counts of those that expired during the study period (see adverse events All-Cause Mortality).
Measured: 90 Days
Mechanical Ventilatory Support
Proportion of patients requiring mechanical ventilatory support.
Measured: Up to 14 Days
Mechanical Ventilatory Support Duration
Duration of invasive mechanical ventilation (days).
Measured: Up to 14 Days
Freedom From Mechanical Ventilation
Invasive mechanical ventilation free days. The outcome was updated to present the number of participants that were without invasive mechanical ventilation while on study.
Measured: Up to 14 Days
Additional Intervention
Did the patient receive an intervention with additional immunomodulatory agent (i.e. IL-6 targeting therapy)? (y/n)
Measured: Up to 14 days
Viral Titer
Change in SARS-CoV-2 viral titers during intervention. Upon entry of results, the time frame was updated to Day 7 to reflect the data collected in the terminated study. Nasopharyngeal (NP) swab were used and the visit window for Day 7 could include days between Day 5 to Day 9. Imputation for < LLOQ: N gene: "<200" is imputed to 2.0 log10 copies/mL (log10(200) - 0.3). ORF1ab gene: "<3000" is imputed to 3.2 log10 copies/mL (log10(3000) - 0.3). Missing Data were not imputed.
Measured: Day 7 (Day 5 to Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start14 Oct 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Chun, Yale University
- Investigators
- Hyung Chun, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415151
- Sponsor's protocol ID
- 2000027848
- Acronym
- I-TOMIC
- Status last verified
- Mar 2025
- First submitted
- 2 Jun 2020
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Tofacitinib to Mitigate the Impact of COVID-19 (I-TOMIC) in Moderate SARS-CoV-2 (MODERATE I-TOMIC)
- ClinicalTrials.gov ID
- NCT04415151
- Acronym / sponsor ID
- I-TOMIC / 2000027848
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized, double blinded, placebo controlled study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation.
Detailed description
The purpose of this randomized, double blinded, placebo controlled Phase 2b study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) male and female patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation (see Inclusion criteria). Sixty patients will be recruited to receive tofacitinib or placebo in addition to standard of care (SOC) in a 1:1 ratio.
Subjects will be screened during hospitalization. Patients with confirmed SARS-CoV-2 infection, and meeting all other Inclusion and Exclusion criteria, will be randomized to either treatment with tofacitinib or placebo in addition to SOC during hospitalization (dose adjusted, if required), with the exception of pre-specified immunomodulatory agents (as documented in the inclusion/exclusion criteria). Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by need for supplementary oxygen), and will continue to be administered at 5 mg PO BID for a total duration of therapy of 14 days; follow-up off tofacitinib will continue up to Day 90. We anticipate completion of subject recruitment in 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Experimental | Drug: Tofacitinib 10 mgTofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercially available or public health assay prior to Day 1.
- Participants with evidence of pneumonia assessed by radiographic imaging (chest x ray or chest CT scan) AND Requiring ≥ 3L O2 OR ≥ 2L O2 and hsCRP > 70 mg/L
- Participants who are hospitalized and receiving supportive care for COVID-19.
- Participant (or legally authorized representative/surrogate) capable of giving signed informed consent.
Key exclusion criteria (35 listed)
- Require mechanical ventilation or ECMO on Day 1 at the time of randomization.
- Have current, or history of, venous thromboembolism (deep vein thrombosis or pulmonary embolism).
- Have a personal or first-degree family history of blood clotting disorders.
- Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (eg, azathioprine, cyclosporine).
- Participants with any current malignancy or lymphoproliferative disorders that requires active treatment
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 |
|---|---|---|
| Tofacitinib 10 mgTofacitinib will be administered in a dose of 10 mg twice daily by mouth (PO BID) until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days. | Drug | Tofacitinib |
| PlaceboMatching placebo tablets will be administered. | Drug | Placebo |
Primary outcome
Disease Severity
Time frame: 14 days
The primary objective of this study is to determine whether tofacitinib improves the clinical outcomes of patients with moderate SARS-CoV-2 infection as determined by the primary outcome measure: Proportion of subjects alive and not needing any form of mechanical ventilation, high flow oxygen, or ECMO by day 14.
15 secondary outcomes
Clinical Improvement (Last Measure)
Time frame: Up to 14 days
Clinical Improvement (Improved Score)
Time frame: Up to 14 days
Time to Recovery
Time frame: Up to 14 days
Time to Clinical Improvement
Time frame: Up to 14 days
Clinical Status
Time frame: Up to 28 Days
Clinical Status
Time frame: 60 Days
Clinical Status
Time frame: 90 Days
Mortality
Time frame: Up to 28 Days
Mortality
Time frame: 60 Days
Mortality
Time frame: 90 Days
Mechanical Ventilatory Support
Time frame: Up to 14 Days
Mechanical Ventilatory Support Duration
Time frame: Up to 14 Days
Freedom From Mechanical Ventilation
Time frame: Up to 14 Days
Additional Intervention
Time frame: Up to 14 days
Viral Titer
Time frame: Day 7 (Day 5 to Day 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hyung Chun, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tofacitinib 10 mg in people with COVID-19 Pneumonia, run by Yale University 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 5 inclusion and 35 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 28 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Severity (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 28 Mar 2025.