Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Prevent Senior Private Operadora de Saúde LTDA.
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
A
B
C
Phase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
Phase B: will only start after 2nd or 3rd administration of phase A. Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).
Phase C: will only start after 2nd or 3rd administration of phase B. Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).