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

NCT ID: NCT04352465

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-11-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Phase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).

B

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).

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Phase B: Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).

C

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).

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Phase C: Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).

Interventions

Methotrexate

Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).

Intervention Type: DRUG

Methotrexate

Phase B: Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).

Intervention Type: DRUG

Methotrexate

Phase C: Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).

Intervention Type: DRUG

Other Intervention Names

MTX-loaded nanoparticles; MTX-loaded nanoparticles; MTX-loaded nanoparticles

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InCor Heart Institute

OTHER

Sponsor Role: collaborator

Hospital Santa Marcelina

OTHER

Sponsor Role: collaborator

Prevent Senior Institute

OTHER

Sponsor Role: collaborator

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prevent Senior Private Operadora de Saúde LTDA.

São Paulo, , Brazil

Countries

Brazil

Central Contacts

Rodrido Esper, MD, PhD

Role: CONTACT

dr.rodrigo.esper@preventsenior.com.br

+55 11 98179-7949

Luciana Ferrara

Role: CONTACT

luciana.ferrara@azidusbrasil.com.br

+55 19 981428814

Facility Contacts

Rodrigo Barbosa Esper

Role: primary

Other Identifiers

LDE-MTX_COVID19

Identifier Type: -

Identifier Source: org_study_id