Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2021-03-31

Brief Summary

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

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Detailed Description

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Conditions

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COVID19 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A (control)

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

Group Type ACTIVE_COMPARATOR

Standard treatment

Intervention Type DRUG

Standard of care according to hospital protocol

Group B (experimental)

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

Group Type EXPERIMENTAL

Cyclosporine

Intervention Type DRUG

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)

Interventions

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Cyclosporine

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)

Intervention Type DRUG

Standard treatment

Standard of care according to hospital protocol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No