COVID-19
Conditions
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 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.
Interventions
DRUGMethotrexate
Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
Sponsors
InCor Heart Institute
Hospital Santa Marcelina
Prevent Senior Institute
Azidus Brasil
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be divided in 3 phases: 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical conditions | 21 days | Clinical condition will be measured by lung injuries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia | 21 days | oxygen saturation |
| Changes of blood oxygen | 21 days | PaO2 / FiO2 ratio |
| Inflammatory parameters | 21 days | C-reactive protein and ferritin |
| Change of Clinical symptoms - respiratory rate | 21 days | Evaluation of Pneumonia change |
| Hospital discharge | 21 dyas | Time to be discharged from hospital |
| ICU discharge | 21 days | Time to be discharged from ICU |
| Rate of mortality | 4 months | Evaluation of change in acute respiratory syndrome |
| Evolution of Acute Respiratory Syndrome | 21 days | Time to wean off oxygen invasive ventilatory support |
Countries
Brazil
Contacts
Primary ContactRodrido Esper, MD, PhD
Backup ContactLuciana Ferrara
Outcome results
None listed