Severe acute respiratory syndrome
Conditions
Interventions
Intervention Group:96 patients will receive naproxen 250mg / 2x day for 5 consecutive days and standard treatment
Placebo Group: 96 patients will receive placebo 250mg / 2x day for 5 consecutive days
Drug
Sponsors
Faculdade de Medicina de São Jose do Rio Preto - FUNFARME/FAMERP
Hospital de Base de São José do Rio Preto
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate all-cause mortality at 28 days in the Naproxeno group compared to the placebo group, | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigate epidemiology, types of SARS-causing viruses, and outcomes during the COVID-19 pandemic;;Investigate the proportion of patients who progress to mechanical ventilatory support in the Naproxen group compared to the placebo group;;Evaluate the proportion of patients not hospitalized on day 28 in the Naproxen group compared to the placebo group;;Investigate the time to improvement of the respiratory condition (time in hours requiring supplemental oxygen or mechanical ventilation) in the Naproxen group compared to the placebo group;;Investigate evolution with organ dysfunctions assessed by the SOFA score by comparing the Naproxen and placebo groups;;Investigate the incidence and duration of treatments in the Naproxen group compared to the placebo group;;Investigate percentage of SARS-Cov-2 detection in oropharyngeal swab samples on day 5 after treatment;;Investigate the safety and tolerability of Naproxen. | — |
Countries
Brazil
Contacts
Public ContactSuzana Lobo
Faculdade de Medicina de São José do Rio Preto - FAMERP
Outcome results
None listed