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| Column | Value |
|---|---|
| Trial registration number | NCT04948203 |
|
Full text link
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
deji@uchicago.edu |
|
Registration date
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
2021-07-01 |
|
Recruitment status
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - adults ≥ 18 years of age - approval from the patient's primary inpatient service - hospitalized - diagnosed with covid-19 pneumonia - positive test for active sars-cov-2 infection - requiring supplemental oxygen ≥ 5lnc or ≥ 40% fio2. - chest computed tomography (ct) at admission with < 10% pulmonary fibrosis - ability to provide written informed consent on the part of the subject or, in the absence of decisional capacity of the subject, an appropriate surrogate (e.g. a legally authorized representative). |
|
Exclusion criteria
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
- known diagnosis of previous pulmonary fibrosis or an interstitial lung disease. - clinical features or known diagnosis of malignancy or active non-covid-19 infection, including untreated latent tuberculosis. - history of unstable or deteriorating cardiac disease (including myocardial infarction, coronary artery bypass surgery or angioplasty within the past 6 months, congestive heart failure requiring hospitalization within the past 6 months, or uncontrolled arrhythmia. - known history of hypersensitivity to sirolimus. - history of unstable or deteriorating neurologic disease (including tias or stroke). - pregnant or lactating females. females of child bearing potential are required to have a negative pregnancy test prior to treatment and practice abstinence or prevent pregnancy by at least a barrier method of birth control. - investigational therapy for any indication within 28 days prior to treatment. - current treatment with any drugs that are strong inhibitors of cyp3a4. - tofacitinib - clarithromycin - telithromycin - nefazodone - itraconazole - ketoconazole - atazanavir - darunavir - indinavir - lopinavir - nelfinavir - ritonavir - saquinavir - tipranavir. - inability or unwillingness to comply with the requirements for the trial. |
|
Number of arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
University of Chicago |
|
Inclusion age min
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
60 |
|
primary outcome
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Prevalence of Pulmonary Fibrosis as evidenced by CT scan |
|
Notes
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 27, 2021, 11:30 a.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "0.5mg", "treatment_id": 1204, "treatment_name": "Sirolimus", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1mg", "treatment_id": 1204, "treatment_name": "Sirolimus", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "2mg", "treatment_id": 1204, "treatment_name": "Sirolimus", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}] |