A phase IIb, double-blind, randomized controlled trial to evaluate the efficacy and safety of Naproxen compared to placebo in combination with Azithromycin or Levofloxacin in patients with Severe Acute Respiratory Syndrome during the Covid-19 pandemic

Faculdade de Medicina de São Jose do Rio Preto - FUNFARME/FAMERP0 个研究点开始时间: 2020年7月10日最近更新: 2023年5月29日

适应症

试验速览

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•Men or women, 18 years of age or older
•Ability to provide informed consent signed by study patient or legally acceptable representative
•Requires ICU hospitalization.
•Respiratory sign or symptom (cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose
•Need for oxygen support using a nasal catheter up to 6 l / min to keep SaO2 above 94% or SpO2 <94% in room air.
•Bilateral infiltrate at Rx or signs suggestive of COVID-19 pneumonia on chest tomography;
•Less than seven days after the first flu-like symptom.

•Need for oxygen support in a nasal catheter over 6 l / min to maintain SaO2 above 93% or signs of respiratory distress for more than 6 h;
•Patient intubated and on mechanical ventilatory support;
•Need for vasopressor or signs of shock;
•Chronic renal failure or AKI Kdigo I or greater;
•History of bleeding or recent peptic ulcer 6 months;
•Suspected infections suggestive of fungal or bacterial etiologies;
•Chronic hepatitis C infection in antiviral therapy;
•Severely immunocompromised in the investigator's opinion (eg, differentiation cluster count 4+ [CD4 +] less than 200 cells / mm3, absolute neutrophil count less than 750 / mm3, first chemotherapy cycle completed in the 2 weeks prior to screening, history of stem cell transplantation within the period of 1 year prior to screening, any history of solid organ transplantation;
•Pregnant women;
•Patients with a life expectancy of less than 30 days

发起方

Faculdade de Medicina de São Jose do Rio Preto - FUNFARME/FAMERP