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
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 covid19
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedApril 29, 2020
April 1, 2020
2 months
April 15, 2020
April 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in clinical conditions
Clinical condition will be measured by lung injuries
21 days
Secondary Outcomes (8)
Change of Clinical symptoms - respiratory rate
21 days
Hypoxia
21 days
Changes of blood oxygen
21 days
Inflammatory parameters
21 days
Evolution of Acute Respiratory Syndrome
21 days
- +3 more secondary outcomes
Study Arms (3)
A
EXPERIMENTALPhase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
B
EXPERIMENTALPhase 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).
C
EXPERIMENTALPhase 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).
Interventions
Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
Eligibility Criteria
You may qualify if:
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Acute respiratory distress syndrome; with imminent risk of death, and with chest CT scan with pulmonary impairment greater than 50%;
- Confirmed or pending diagnosis of COVID-19.
You may not qualify if:
- Pleural effusion \> 150mL or ascites \> 200mL;
- Chronic liver disease;
- ALT and AST serum levels \>= three times the upper limit of normality;
- Renal failure (dialysis)
- Multiple organ failure
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azidus Brasillead
- InCor Heart Institutecollaborator
- Hospital Santa Marcelinacollaborator
- Prevent Senior Institutecollaborator
Study Sites (1)
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 20, 2020
Study Start
May 1, 2020
Primary Completion
June 30, 2020
Study Completion
November 30, 2020
Last Updated
April 29, 2020
Record last verified: 2020-04