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

Tatiana Cobo Ibáñez0 个研究点目标入组 174 人开始时间: 2020年5月8日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•- 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

•- 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).

发起方

Tatiana Cobo Ibáñez