COVID-19Phase 1/2NCT04352465
Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients
A Phase 1/2 study testing Methotrexate in people with COVID-19, run by Azidus Brasil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2020to 30 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Prevent Senior Private Operadora de Saúde LTDA.
São Paulo
Rodrigo Barbosa Esper
About this study
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
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.
Read the 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
- Being tested
- Methotrexate
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called MTX-loaded nanoparticles
Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
MethotrexateDrug
Also called MTX-loaded nanoparticles
Phase B: Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).
MethotrexateDrug
Also called MTX-loaded nanoparticles
Phase C: Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Phase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses). Receives: Drug: Methotrexate |
| B | Experimental | 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). Receives: Drug: Methotrexate |
| C | Experimental | 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). Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical conditions
Clinical condition will be measured by lung injuries
Measured: 21 days
Secondary outcomes (8)
Change of Clinical symptoms - respiratory rate
Evaluation of Pneumonia change
Measured: 21 days
Hypoxia
oxygen saturation
Measured: 21 days
Changes of blood oxygen
PaO2 / FiO2 ratio
Measured: 21 days
Inflammatory parameters
C-reactive protein and ferritin
Measured: 21 days
Evolution of Acute Respiratory Syndrome
Time to wean off oxygen invasive ventilatory support
Measured: 21 days
Hospital discharge
Time to be discharged from hospital
Measured: 21 dyas
ICU discharge
Time to be discharged from ICU
Measured: 21 days
Rate of mortality
Evaluation of change in acute respiratory syndrome
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study will be divided in 3 phases: Phase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses). 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). 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).
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InCor Heart Institute, Hospital Santa Marcelina, Prevent Senior Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352465
- Sponsor's protocol ID
- LDE-MTX_COVID19
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04352465
- Acronym / sponsor ID
- LDE-MTX_COVID19
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- InCor Heart Institute, Hospital Santa Marcelina, Prevent Senior Institute
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will be divided in 3 phases: Phase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses). 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). 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).
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MethotrexatePhase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses). |
| B | Experimental | Drug: MethotrexatePhase 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 | Experimental | Drug: MethotrexatePhase 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: MTX-loaded nanoparticlesPhase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses). | Drug | A |
| MethotrexateAlso: MTX-loaded nanoparticlesPhase B: Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses). | Drug | B |
| MethotrexateAlso: MTX-loaded nanoparticlesPhase C: Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses). | Drug | C |
Primary outcome
Change in clinical conditions
Time frame: 21 days
Clinical condition will be measured by lung injuries
8 secondary outcomes
Change of Clinical symptoms - respiratory rate
Time frame: 21 days
Hypoxia
Time frame: 21 days
Changes of blood oxygen
Time frame: 21 days
Inflammatory parameters
Time frame: 21 days
Evolution of Acute Respiratory Syndrome
Time frame: 21 days
Hospital discharge
Time frame: 21 dyas
ICU discharge
Time frame: 21 days
Rate of mortality
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Methotrexate in people with COVID-19, run by Azidus Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrido Esper, MD, PhD (+55 11 98179-7949, dr.rodrigo.esper@preventsenior.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical conditions (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.