COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001467-82/NL

Leiden University Medical Center - Dr. Y.K.O. Teng

y.k.o.teng@lumc.nl

2020-04-28

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Provide written informed consent, in accordance with EMA guidance on the management of clinical trials during COVID-19 pandemic (Version 2, 27 March 2020). If written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent could be given orally by the trial participant (Art 2(j) of Directive 2001/20/EC) in the presence of an impartial witness. In such cases, the witness is required to sign and date the informed consent document and the Investigator is expected to record how the impartial witness was selected. 2. Male or female subjects with a minimum age of 18 years (or legal age of consent if <18 years) at Visit 1. 3. 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. 4. 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.

1. Subjects unable or unwilling to give written informed consent and/or to comply with study procedures. 2. Any known hypersensitivity or contraindication to CNIs, especially CsA, or components of any cyclosporine drug product. 3. 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. 4. Severe symptoms resulting from SARS-CoV-2 infection requiring positive pressure ventilation at baseline. 5. 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. 6. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 7. 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. 8. Subjects less than 3 months post-transplant. 9. Subjects with documented organ rejection within the past 3 months. 10. Subjects with a documented estimated glomerular filtration rate (eGFR) <15 ml/min within the previous 3 months prior to screening.

2

Leiden University Medical Center

18

100

Netherlands

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

30

The main endpoint is the reduction in SARS-CoV-2 viral load over 28 days, as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR).

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1377, "treatment_name": "Voclosporin", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]