Clinical trial NCT04392531: Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19
Official title: Open, Controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Cyclosporine Plus Standard Treatment vs Standard Treatment Only in Hospitalized Patients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID19 Infection
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Women and men over 18 years old
2. 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)
3. Acceptance and signing of the consent for the study after having received the appropriate information.

Exclusion criteria

1. Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components.
2. 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
3. Kidney failure (Stages 4 and 5: GFR \<30 ml / min according to the cockcroft-Gault formula).
4. Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B
5. Pregnancy or lactation
6. Age over 75 years
7. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed.
8. Refusal to participate
9. 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
10. At the investigator's discretion, the patient's inability to understand or comply with the study procedures

Primary outcomes:
measure: Severity Category
timeFrame: 12 days
Secondary outcomes:
measure: Mortality Rate
timeFrame: through study completion, an average of 6 weeks
measure: Number of Days in hospital
timeFrame: through study completion, an average of 6 weeks
measure: Number of days in ICU beds
timeFrame: through study completion, an average of 6 weeks
measure: Fio2 Needs
timeFrame: through study completion, an average of 6 weeks
measure: Adverse events rate
timeFrame: through study completion, an average of 6 weeks
measure: Change in CRP
timeFrame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
measure: Change in ferritin
timeFrame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
measure: Change in LDH
timeFrame: every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)
measure: Change in CPK
timeFrame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
measure: Change in D Dimer
timeFrame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
measure: Change in IL-6
timeFrame: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
measure: Change in KL-6
timeFrame: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
measure: Change in Viral Load
timeFrame: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
measure: Change specific antibodies
timeFrame: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Other outcomes:
Locations:
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario La Coruña
state: Galicia
city: La Coruña
country: Spain
facility: Hospital Quiron La Coruña
state: Galicia
city: Mostoles
country: Spain
facility: Hospital Rey Juan Carlos
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Infanta Elena
state: Madrid
city: Villalba
country: Spain
facility: Hospital General de Villalba
state: Madrid
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra
Study officials:
affiliation: FUNDACION JIMENEZ DIAZ
name: Olga Sanchez Pernaute, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: