Cyclosporine in Patients With Moderate COVID-19
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|ClinicalTrials.gov Identifier: NCT04412785|
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Cyclosporine||Phase 1|
Our overall hypothesis is that CSA is safe in this patient population and that it will have antiviral and anti-cytokine effects as measured in laboratory tests.
The initial dose will be 9 mg/kg/day oral divided q12h or 3 mg/kg/day by continuous IV infusion. Oral administration is generally preferred, however IV administration can be used if oral administration is not feasible or cannot be tolerated, or at the physician-investigator's clinical discretion. The dose will be adjusted to target a trough level of 200 to 300 ng/ml, which is in alignment with common clinical practice. The planned duration of CSA treatment is up to 14 days, with planned discontinuation upon discharge from the hospital. Dose reduction of 25% to 50% can be made for patients who experience adverse events such as hypertension or serum creatinine elevation.
The end of study will be study day 30 for those patients who have been discharged from the hospital. If the patient remains in the hospital, the subject will still complete the end of study visit at day 30 as planned, but will continue to be followed until date of discharge.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial for the Prevention of Cytokine Release Syndrome (CRS) With Cyclosporine in Patients With Moderate COVID-19|
|Actual Study Start Date :||June 22, 2020|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Single Arm
Cyclosporine; oral or IV route of administration, per investigator discretion. Duration of administration up to 14 days, as tolerated.
• The initial dose will be 9 mg/kg/day oral divided q12h. For IV, the dose will be 3mg/kg/day by continuous IV infusion.
Other Name: Sandimmune, Neoral, Gengraf
- Safety-oxygen, ICU transfer and ventilation [ Time Frame: 3 months ]Safety will be measured: By assessing the proportion of participants requiring increase in oxygen requirements, transfer to intensive care unit, and/or mechanical ventilation
- Safety-changes in absolute lymphocyte count [ Time Frame: 3 months ]Safety will be assessed: By monitoring changes in absolute lymphocyte counts
- Safety-changes in creatinine clearance [ Time Frame: 3 months ]Safety will be assessed: By monitoring changes in creatinine clearance. Creatinine clearance will be estimated using the Cockcroft-Gault formula.
- Safety-secondary bacterial infections [ Time Frame: 3 months ]Safety will be assessed: By monitoring the incidence of secondary bacterial infections complicating COVID-19 hospitalization
- Laboratory measurements of safety and antiviral efficacy related to COVID-19-SARS-CoV-2 by measuring the clearance of SARS-CoV-2 from respiratory secretions [ Time Frame: 3 months ]To measure time to SARS-CoV-2 clearance (PCR negativity) at Days 7 and 14 by deep nasal swab
- Laboratory measurements-D-dimer levels [ Time Frame: 3 months ]To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: D-dimer levels
- Laboratory measurements-ferritin [ Time Frame: 3 months ]To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: ferritin levels
- Laboratory measurements- IL-6 [ Time Frame: 3 months ]To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: IL-6 levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412785
|Contact: Joan Gilmoreemail@example.com|
|Contact: Karen Dengel, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Joan Gilmore 215-746-8902 email@example.com|
|Contact: Karen Dengel, RN firstname.lastname@example.org|
|Principal Investigator: Emily Blumberg, MD|
|Principal Investigator:||Emily Blumberg, MD||University of Pennsylvania|