CLINICAL STUDY IN WHICH PATIENTS ARE RANDOMIZED TO RECEIVE CYCLOSPORINE VS. NON TREATMENT ASSOCIATED TO STANDARD OF CARE TO COMPARE THEIR EFFICACY IN THE COVID-19 PNEUMONIA.

EFFICACY OF CYCLOSPORINE IN THE TREATMENT OF COVID-19 PNEUMONIA: A RANDOMIZED CONTROLLED TRIAL. - CYCLO STUDY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002123-11-ES

Enrollment

174

Registered

2020-05-08

Start date

2020-05-07

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 PNEUMONIA MedDRA version: 23.1 Level: LLT Classification code 10084383 Term: Novel COVID-19-infected pneumonia System Organ Class: 100000004862

Interventions

Trade Name: Sandimmun Neoral 25 mg cápsulas blandas Sandimmun Neoral 50 mg cápsulas blandas Sandimun Neoral 100 mg cápsulas blandas Pharmaceutical Form: Capsule, soft INN or Proposed INN: CICLOSPORIN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: - Contraindication for the prescription of any of the study treatments. - Inability to sign informed consent. - Patient diagnosed with ILD. - Allergy or intolerance to the active substance or the excipients. - That the patient already participates in studies with other investigational treatments for COVID-19. - Regular treatment with oral corticosteroids for disease other than COVID-19 at a dose of prednisone> 10 mg / day or equivalent. - Treatment in the previous 30 days with IL1 or IL6 inhibitors. - Treatment in the previous 2 months with intravenous immunoglobulins. - Treatment in the previous 2 months with other biological therapies other than rituximab and the Il1 or Il6 inhibitors. - Treatment in the previous 6 months with rituximab. - Kidney failure with estimated GFR 180/100 despite adequate pharmacological treatment). - Evidence of an intercurrent active bacterial, tuberculous, or fungal process. - AST / ALT values ??greater than 5 times the upper limit of normality - Neutrophils 29).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of cyclosporine A (treatment group) versus non treatment (control group) in patients with acute COVID-19 pneumonia .;Secondary Objective: Objective 1: To estimate the lack of response 3 months after the diagnosis of COVID-19 pneumonia, differentiating whether it is due to death or development of diffuse interstitial lung disease (ILD). Objective 2: To assess the need for pharmacological rescue and invasive mechanical ventilation with orotracheal intubation 3 months after the diagnosis of COVID-19 pneumonia. Objectives 3: To evaluate the safety of the therapeutic strategies of interest 3 months after the diagnosis of COVID-19 pneumonia.;Primary end point(s): Rate of patients achieving complete response 3 months after being diagnosed of COVID-19 pneumonia.;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy of cyclosporine A (treatment group) versus non treatment (control group) in patients with acute COVID-19 pneumonia .;Secondary Objective: Objective 1: To estimate the lack of response 3 months after the diagnosis of COVID-19 pneumonia, differentiating whether it is due to death or development of diffuse interstitial lung disease (ILD). Objective 2: To assess the need for pharmacological rescue and invasive mechanical ventilation with orotracheal intubation 3 months after the diagnosis of COVID-19 pneumonia. Objectives 3: To evaluate the safety of the therapeutic strategies of interest 3 months after the diagnosis of COVID-19 pneumonia.;Primary end point(s): Rate of patients achieving complete response 3 months after being diagnosed of COVID-19 pneumonia.;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 3 months;Secondary end point(s): 1. Rate of patients achieving partial response 3 months after diagnosis of COVID-19 pneumonia. 2. Rate of patients who do not reach a response 3 months after the diagnosis of COVID-19 pneumonia, differentiating whether it is due to death or due to the development of ILD. 3. Rate of patients receiving invasive mechanical ventilation (IMV) with orotracheal intubation (IOT) 3 months after the diagnosis of COVID-19 pneumonia. 4. Rate of patients requiring rescue treatment with methylprednisolone or biological therapy 3 months after the diagnosis of COVID-19 pneumonia. 5. Time elapsed from diagnosis to response, receiving IMV with IOT, and requiring rescue treatment with methylprednisolone or biological therapy. 6. Frequency and incidence of adverse events after 3 months of being diagnosed of COVID-19 pneumonia.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 3 months;Secondary end point(s): 1. Rate of patients achieving partial response 3 months after diagnosis of COVID-19 pneumonia. 2. Rate of patients who do not reach a response 3 months after the diagnosis of COVID-19 pneumonia, differentiating whether it is due to death or due to the development of ILD. 3. Rate of patients receiving invasive mechanical ventilation (IMV) with orotracheal intubation (IOT) 3 months after the diagnosis of COVID-19 pneumonia. 4. Rate of patients requiring rescue treatment with methylprednisolone or biological therapy 3 months after the diagnosis of COVID-19 pneumonia. 5. Time elapsed from diagnosis to response, receiving IMV with IOT, and requiring rescue treatment with methylprednisolone or biological therapy. 6. Frequency and incidence of adverse events after 3 months of being diagnosed of COVID-19 pneumonia.

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Countries

Spain

Contacts

Public ContactTatiana Cobo Ibañez

Hospital Universitario Infanta Sofía

mtatiana.cobo@salud.madrid.org34911914037

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026