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.
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 nanoparticules in patients with acute lung injury secondary to COVID-19 aims to
decrease the exacerbated inflammatory reaction leading to a decrease in cell damage caused by
this inflammatory process in patients.
The study will be divided in 3 phases:
Phase A (n=4): IV administration of 20 mg of MTX-loaded nanoparticles. Four doses of
Investigational Product (IP) will be administered, once per week. If patients show clinical
improvement after 2nd or 3rd administration, the next phase will start.
Phase B (n=12): IV administration of 30 mg of MTX-loaded nanoparticles. Four doses of
Investigational Product (IP) will be administered, once per week. If patients show clinical
improvement after 2nd or 3rd administration, the next phase will start.
Fase C (n=26): IV administration of 40 mg of MTX-loaded nanoparticules. Four doses of
Investigational Product (IP) will be administered, once per week.
Drug: Methotrexate
Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
Other Name: MTX-loaded nanoparticles
Drug: Methotrexate
Phase B: Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).
Other Name: MTX-loaded nanoparticles
Drug: Methotrexate
Phase C: Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).
Other Name: MTX-loaded nanoparticles
Inclusion Criteria:
1. Informed consent from patient or legal representative.
2. Male or female, aged ≥ 18 years;
3. Acute respiratory distress syndrome; with imminent risk of death, and with chest CT
scan with pulmonary impairment greater than 50%;
4. Confirmed or pending diagnosis of COVID-19.
Exclusion Criteria:
1. Pleural effusion > 150mL or ascites > 200mL;
2. Chronic liver disease;
3. ALT and AST serum levels >= three times the upper limit of normality;
4. Renal failure (dialysis)
5. 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
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo, Brazil
Investigator: Rodrigo Barbosa Esper
Rodrido Esper, MD, PhD
+55 11 98179-7949
dr.rodrigo.esper@preventsenior.com.br
Luciana Ferrara
+55 19 981428814
luciana.ferrara@azidusbrasil.com.br