NCT04352465

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-06-30
• Completion: 2020-11-30
• First posted: 2020-04-20
• Last updated: 2020-04-29

Locations

1 site across 1 country: Brazil