Status:
UNKNOWN
Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
InCor Heart Institute
Hospital Santa Marcelina
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study is to evaluate the efficacy and safety of MTX-loaded nanoparticles in three different doses to treat severe COVID-19 patients.
Detailed Description
Patients with acute lung injury caused by COVID-19 disease are experiencing an inflammatory reaction that can be harmful and worsen the severity of the clinical condition. Thus, the use of MTX-loaded ...
Eligibility Criteria
Inclusion
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Acute respiratory distress syndrome; with imminent risk of death, and with chest CT scan with pulmonary impairment greater than 50%;
- Confirmed or pending diagnosis of COVID-19.
Exclusion
- Pleural effusion \> 150mL or ascites \> 200mL;
- Chronic liver disease;
- ALT and AST serum levels \>= three times the upper limit of normality;
- Renal failure (dialysis)
- Multiple organ failure
- 7\. Concomitant use or use in the last 7 days of cell therapy with stem cells; 8. Any clinical or laboratory condition or comorbidity that, at medical discretion, 9. Known hypersensitivity to the investigational product; 10. Subject who is pregnant or lactating
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04352465
Start Date
May 1 2020
End Date
November 30 2020
Last Update
April 29 2020
Active Locations (1)
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1
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo, Brazil