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

NCT04352465 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-04-29

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • Hospital Santa Marcelina

    collaborator OTHER

  • Prevent Senior Institute

    collaborator OTHER

  • Azidus Brasil

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2020-06-30
Completion
2020-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04352465 on ClinicalTrials.gov