Status:
COMPLETED
Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions:
COVID19 Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Women and men over 18 years old
- Clinical diagnosis of COVID19 infection (to be subsequently confirmed by PCR or specific IgM isotype Ac and with entry criteria according to the protocol of action (see Annex 2)
- Acceptance and signing of the consent for the study after having received the appropriate information.
- Exclusion criteria
- Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components.
- Contraindication for the use of any of the medications included (\*)
- CsA: IR EST 4.5 (FG \<30 ml / min according to the Cockcroft-Gault formula)
- Antimalarials (Chloroquine, hydroxychloroquine): Retinopathy, Myasthenia gravis.
- Lopinavir / ritonavir: severe liver failure
- Remdesivir, darunovir-ritonavir
- Doxycycline, Azithromycin
- Kidney failure (Stages 4 and 5: GFR \<30 ml / min according to the cockcroft-Gault formula).
- Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B
- Pregnancy or lactation
- Age over 75 years
- Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed.
- Refusal to participate
- Patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions
- At the investigator's discretion, the patient's inability to understand or comply with the study procedures
Exclusion
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04392531
Start Date
April 16 2020
End Date
March 31 2021
Last Update
July 14 2022
Active Locations (7)
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1
Complejo Hospitalario Universitario La Coruña
A Coruña, Galicia, Spain
2
Hospital Quiron La Coruña
A Coruña, Galicia, Spain
3
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain, 28933
4
Hospital Infanta Elena
Valdemoro, Madrid, Spain, 28342