RBR-3rywwg
Recruiting
Phase 2
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 sitesJuly 10, 2020
ConditionsSevere acute respiratory syndrome
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Severe acute respiratory syndrome
- Sponsor
- Faculdade de Medicina de São Jose do Rio Preto - FUNFARME/FAMERP
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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