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.

Phase 1

• Conditions: COVID-19 PNEUMONIA; MedDRA version: 23.1Level: LLTClassification code 10084383Term: Novel COVID-19-infected pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002123-11-ES
• Lead Sponsor: Tatiana Cobo Ibáñez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-08
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

- Adult = 18 years and <80 years.
- Very characteristic initial symptoms of SARS-CoV2 infection (fever and / or cough and / or dyspnea and / or myalgia and / or asthenia and / or diarrhea) = 7 days in duration.
- Presence of alveolar-interstitial lung infiltrates.
- Basal oxygen saturation <95%.
-Hospitalization.
- Patient status = 3 according to the WHO clinical improvement ordinal scale.
- Positivity for the SAR-CoV2 PCR of nasal and pharyngeal exudate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

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 <30ml / min
- HTA of difficult control (TA> 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 <500 cells / mm3 or Platelets <50,000 cells / mm3.
- Active neoplasms.
- Pregnancy and lactation.
- Significant comorbidity (CIRS scale> 29).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>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.<br>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

Secondary Outcome Measures

Name	Time	Method
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.<br>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.<br>3. Rate of patients receiving invasive mechanical ventilation (IMV) with orotracheal intubation (IOT) 3 months after the diagnosis of COVID-19 pneumonia.<br>4. Rate of patients requiring rescue treatment with methylprednisolone or biological therapy 3 months after the diagnosis of COVID-19 pneumonia.<br>5. Time elapsed from diagnosis to response, receiving IMV with IOT, and requiring rescue treatment with methylprednisolone or biological therapy.<br>6. Frequency and incidence of adverse events after 3 months of being diagnosed of COVID-19 pneumonia.