NCT04392531

Brief Summary

The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

May 3, 2020

Last Update Submit

July 13, 2022

Conditions

COVID19 Infection

Outcome Measures

Primary Outcomes (1)

  • Severity Category

    efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.

    12 days

Secondary Outcomes (14)

  • Mortality Rate

    through study completion, an average of 6 weeks

  • Number of Days in hospital

    through study completion, an average of 6 weeks

  • Number of days in ICU beds

    through study completion, an average of 6 weeks

  • Fio2 Needs

    through study completion, an average of 6 weeks

  • Adverse events rate

    through study completion, an average of 6 weeks

  • +9 more secondary outcomes

Study Arms (2)

Group A (control)

ACTIVE COMPARATOR

The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.

Drug: Standard treatment

Group B (experimental)

EXPERIMENTAL

The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.

Drug: Cyclosporine

Interventions

CyclosporineDRUG

In the experimental group, cyclosporine will be started according to patient weight, and then increased depending on patient tolerance (monitoring renal function and blood pressure)

Group B (experimental)
Standard treatmentDRUG

Standard of care according to hospital protocol

Group A (control)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Complejo Hospitalario Universitario La Coruña

A Coruña, Galicia, Spain

Location

Hospital Quiron La Coruña

A Coruña, Galicia, Spain

Location

Hospital Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

Location

Hospital Infanta Elena

Valdemoro, Madrid, 28342, Spain

Location

Hospital General de Villalba

Villalba, Madrid, 28400, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Clinica Universitaria de Navarra

Madrid, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Olga Sanchez Pernaute, MD, PhD

    FUNDACION JIMENEZ DIAZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 19, 2020

Study Start

April 16, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations

ES(7)