Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients

COVID-19 Clinical Trial

Official title:

Treatment of Acute Respiratory Syndrome Resulting From the Inflammatory Process of COVID-19 Infection Using Methotrexate-loaded Nanoparticles: A Phase I/II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04352465
• Other study ID #: LDE-MTX_COVID19
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2020
• Source: Azidus Brasil
• Contact: Rodrido Esper, MD, PhD
• Phone: +55 11 98179-7949
• Email: dr.rodrigo.esper[@]preventsenior.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: November 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Methotrexate
Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
• Methotrexate
Phase B: Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).
• Methotrexate
Phase C: Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).

Locations

Country	Name	City	State
Brazil	Prevent Senior Private Operadora de Saúde LTDA.	São Paulo

Sponsors (4)

Lead Sponsor	Collaborator
Azidus Brasil	Hospital Santa Marcelina, InCor Heart Institute, PREVENT SENIOR PRIVATE OPERADORA DE SAÚDE LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical conditions	Clinical condition will be measured by lung injuries	21 days
Secondary	Change of Clinical symptoms - respiratory rate	Evaluation of Pneumonia change	21 days
Secondary	Hypoxia	oxygen saturation	21 days
Secondary	Changes of blood oxygen	PaO2 / FiO2 ratio	21 days
Secondary	Inflammatory parameters	C-reactive protein and ferritin	21 days
Secondary	Evolution of Acute Respiratory Syndrome	Time to wean off oxygen invasive ventilatory support	21 days
Secondary	Hospital discharge	Time to be discharged from hospital	21 dyas
Secondary	ICU discharge	Time to be discharged from ICU	21 days
Secondary	Rate of mortality	Evaluation of change in acute respiratory syndrome	4 months