Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients (VOCOVID)
Covid19, Kidney Transplant Infection
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent.
- Male or female subjects with a minimum age of 18 years at Visit 1.
- Subjects with a stable kidney transplant taking TAC and a confirmed diagnosis of SARS-CoV-2 by nuclear acid testing, with mild-to-moderate symptoms.
- Patients with mild-to-moderate disease symptoms in which mild disease is defined by non-hospitalized patients without oxygen need and moderate disease symptoms are defined by hospitalization to a nursing ward with the need of oxygen therapy.
- Women of childbearing potential must have a negative pregnancy test at baseline. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study.
Exclusion Criteria:
- Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
- Any known hypersensitivity or contraindication to CNIs, especially CsA, or components of any cyclosporine drug product.
Current or medical history of:
- Congenital immunodeficiency.
- Severe, known, active viral infections, excluding SARS-CoV-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus or HIV) that are deemed to interfere with study assessments or outcome according to Investigator's judgement.
- Severe symptoms resulting from SARS-CoV-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline.
- Other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to Investigator's judgement.
- Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
- Participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline.
- Subjects less than 3 months post-transplant.
- Subjects with documented organ rejection within the past 3 months.
- Subjects with a documented estimated glomerular filtration rate (eGFR) <15 ml/min within the previous 3 months prior to screening.
Sites / Locations
- Leiden University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Voclosporin (VCS)
Tacrolimus (TAC)
Prior to or at study entry, subjects are reduced in their standard immunosuppressive therapy to dual therapy with prednisone and tacrolimus according to current local guidelines. In the experimental arm tacrolimus is switched to voclosporin 6 capsules (of 7.9 mg each) BID for a treatment period of minimal 56 days with a possible extension up to 1 year. Safety drug monitoring will take place during the study to ensure that VCS trough levels are maintained between 30-60 ng/mL. If trough levels are not within these levels, dose adjustments will take place.
Prior to or at study entry, subjects are reduced in their standard immunosuppressive therapy to dual therapy with prednisone and tacrolimus according to current local guidelines. In the Active comparator arm tacrolimus dosage is maintained. Safety drug monitoring will take place during the study to ensure that TAC trough levels are maintained between 3-7 ng/ml. If trough levels are not within these levels, dose adjustments will take place.