COVID-19 Pneumonia Clinical Trial
Official title:
SECOVID: A Multi-center, Randomized, Dose-ranging Parallel-group Trial Assessing the Efficacy of Sirolimus in Hospitalized Patients With COVID-19 Pneumonia for the Prevention of Post-COVID Fibrosis
The primary purpose of this study is to determine whether the drug sirolimus reduces the likelihood of developing of pulmonary fibrosis in patients who are hospitalized with COVID-19 pneumonia.
Hospitalized patients with a diagnosis of COVID-19 pneumonia will be referred to the study team for potential recruitment. Initial screening will take place using the existing medical record and in collaboration with the treating team. The study consists of 3 randomly assigned arms of varying dosages of the study drug All procedures, with the exception of drug dosing and option sample analysis, align with the subject's standard of care. Prior to initiating study drug, the subject's standard of care labs, imaging and oxygen requirements will be reviewed. Sirolimus will be administered as an oral medication. Subjects who are discharged prior to receiving 14 days of study drug will be provided with enough study drug to finish at home. On-study evaluation includes measurement of vital signs and laboratory studies before and after a patient has received sirolimus while inpatient. As part of routine care, subjects will be seen daily while in the hospital and will be monitored through blood tests for general health as well as renal function. Vital signs will be monitored daily while in the hospital, physical exams, assessment of COVID-19, and CT scans or chest x-rays as necessary for routine care. Subjects will return to clinic at 12 weeks for routine lab work and imaging as a part of study follow-up and will be assessed for pulmonary fibrosis at this time. Additionally, University of Chicago Medicine patients will have the option to allow investigators to use leftovers from tubes of blood drawn for clinical tests that would otherwise be discarded. This will apply to any blood collected during that respective hospital stay as well as up to 1 year after study enrollment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT04901676 -
Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia
|
Phase 3 | |
| Not yet recruiting |
NCT04534478 -
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19
|
Phase 4 | |
| Active, not recruiting |
NCT05002517 -
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab
|
Phase 3 | |
| Completed |
NCT05008393 -
Efficacy of PJS-539 for Adult Patients With COVID-19.
|
Phase 2 | |
| Completed |
NCT04569877 -
GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia
|
Phase 2 | |
| Not yet recruiting |
NCT05286255 -
Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias
|
Phase 1 | |
| Completed |
NCT05035589 -
The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
|
||
| Recruiting |
NCT06113432 -
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
|
N/A | |
| Recruiting |
NCT05042063 -
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
|
||
| Recruiting |
NCT04615429 -
Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
|
Phase 2 | |
| Completed |
NCT05047653 -
RALE Versus CORADS/CT-Severity Score in COVID-19
|
||
| Active, not recruiting |
NCT05047016 -
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
|
N/A | |
| Active, not recruiting |
NCT05033847 -
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
|
Phase 2 | |
| Recruiting |
NCT06113757 -
Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease
|
N/A | |
| Completed |
NCT05504655 -
N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients:
|
||
| Active, not recruiting |
NCT05035524 -
A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19
|
N/A | |
| Completed |
NCT05065879 -
Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes
|
Phase 4 | |
| Withdrawn |
NCT04390217 -
LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
|
Phase 2 | |
| Withdrawn |
NCT04460105 -
Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia
|
Phase 1 | |
| Suspended |
NCT04901689 -
Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation
|
Phase 3 |