COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-3rywwg

Suzana Lobo

joelmavg@gmail.com

2020-07-10

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

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

2

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

18

100

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

Investigate all-cause mortality at 28 days in the Naproxeno group compared to the placebo group;

Phase 2

[{"arm_notes": "", "treatment_id": 860, "treatment_name": "Naproxen", "treatment_type": "Non-steroidal anti-inflammatory", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]