CoronavirusPhase 1/2Nano-COVID19NCT04610567
Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19)
A Phase 1/2 study testing Methotrexate-LDE phase 1 and Methotrexate-LDE phase 2 in people with Coronavirus and Inflammation, run by University of Sao Paulo General Hospital at 3 sites in Brazil.
Trial summary
The investigators propose a prospective, randomized, double-blind, placebo-controlled study, conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed with mild Coronavirus-19(COVID-19) disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronavirus, Inflammation, Covid19
- What is being tested?
- Methotrexate-LDE phase 1 and Methotrexate-LDE phase 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesBrazil
- Study dates
- 27 Oct 2020to 15 Jul 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were hospitalized with confirmed COVID-19
- Mild Coronavirus-19 disease (WHO Coronavirus-19 scale < 5)
- Fewer than 14 days since symptom onset.
- Female patient is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile.
- Female patient is of childbearing potential must has a negative pregnancy test.
- Signing the study informed consent.
Who cannot join
- Need for oxygen supplementation >4 L/min via nasal cannula or ≥40% via Venturi mask.
- Need for oxygen supplementation via high-flow nasal cannula.
- Need for invasive mechanical ventilation.
- Extent of pulmonary involvement > 50% by CT scan.
- Chronic renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m2)
- History of liver cirrhosis (Bilirubins levels > 3mg/dl)
Show all 19Show fewer
- History of heart failure ( Ejection fraction <40%)
- History of Steven-Johnson disease
- History of stroke in the last 6 months
- History of sickle cell disease
- Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers.
- Prior history of chronic hepatitis B or C infection and known HIV positive.
- Patient undergoing chemotherapy for cancer
- Sepsis caused by fungal or multidrug resistant gram-negative bacteria
- Known allergy to methotrexate.
- Body mass index(BMI) > 40 or <18.5
- Pregnancy or breastfeeding.
- Patients enrolled in other clinical trials in the last 12 months
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Heart Institute (InCor) - University of São Paulo Medical School, São Paulo, Brazil
São Paulo, São Paulo, 05403900
Lucas Marinho, MD, +5511948045001, lucaslage@hotmail.com
- Not yet recruiting
Hospital Santa Marcelina
São Paulo, São Paulo
Jose Salvador Oliveira, MD;PhD
- Not yet recruiting
Institute Prevent Senior
São Paulo, São Paulo
Rodrigo Esper, MD;PhD
About this study
Official title: Two Phases Clinical Trial to Evaluate Safety and Efficacy of Methotrexate Associated to LDL Like Nanoparticles (LDE-MTX) in the Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease.
The investigators propose a prospective, randomized, double-blind, placebo-controlled study, conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed with mild Coronavirus-19(COVID-19) disease.
A total of 100 patients will be randomized to receive MTX-LDE or placebo each 7 days, up to 3 times, during in hospital treatment.
Read the detailed description
The objective of the study is to evaluate the safety and efficacy of (MTX -LDE) in patients with mild Coronavirus-19 (COVID-19) disease.
In phase 1, firstly 3 patients with moderate COVID-19 disease will receive MTX-LDE IV 15mg each 7 days, up to 3 times, during hospitalization. After that, 9 patients with moderate COVID-19 disease will receive MTX-LDE IV 30mg each 7 days, up to 3 times, during hospitalization. Follow-up assessments will occur daily following randomization during in hospital treatment and 2 weeks after discharge for evaluation of the occurrence of adverse events.The purpose of this phase will be evaluate safety and pharmacokinetics.
If no objection by data and safety monitoring board (DSMB), will be authorized to start the second phase.
In phase 2, 88 patients with moderate COVID-19 disease will be randomized to receive MTX-LDE IV 30mg or placebo-LDE IV each 7 days, up to 3 times, during hospitalization. Follow-up assessments will occur daily following randomization during in hospital treatment and 2 weeks after discharge for evaluation of the occurrence of any trial endpoints or other adverse events.The primary endpoint of this phase will be reduction in duration of hospitalization stay between groups.
Patients will undergo clinical and laboratory safety evaluations daily. An algorithm for drug suspension based on clinical and laboratory finding will be followed.
- Conditions
- Coronavirus, Inflammation, Covid19
- Being tested
- Methotrexate-LDE phase 1, Methotrexate-LDE phase 2, Placebo-LDE phase 2
- Keywords
- coronavirus, inflammation, nanoparticles, methotrexate, covid19
- Medical subject headings
- Coronavirus Infections, Inflammation, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate-LDE phase 1Drug
Also called MTX-LDE phase 1
3 patients will receive MTX-LDE at the dose of 15mg IV each 7 days during hospitalization, up to 3 times . After that, 9 patients will receive MTX-LDE at the dose of 30mg IV each 7 days during hospitalization, up to 3 times .
All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of MTX-LDE
Methotrexate-LDE phase 2Drug
Also called MTX-LDE phase 2
44 patients will receive MTX-LDE at the dose of 30mg IV each 7 days during hospitalization, up to 3 times dose of 30mg IV each 7 days during hospitalization, up to 3 times . All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of MTX-LDE
Placebo-LDE phase 2Drug
44 patients will receive Placebo-LDE IV each 7 days during hospitalization, up to 3 times dose of 30mg IV each 7 days during hospitalization, up to 3 times . All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of Placebo-LDE
| Study group | Role | What they receive |
|---|---|---|
| MTX-LDE phase 1 | Experimental | Methotrexate carried by a lipid nanoparticle (MTX-LDE) Receives: Drug: Methotrexate-LDE phase 1 |
| MTX-LDE phase 2 | Experimental | Methotrexate carried by a lipid nanoparticle (MTX-LDE) Receives: Drug: Methotrexate-LDE phase 2 |
| Placebo-LDE phase 2 | Placebo comparator | Lipid nanoparticle (LDE) Receives: Drug: Placebo-LDE phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Compare the duration of hospital stay between groups
Measured: 30 days after randomization
Secondary outcomes (12)
Number of participants requiring mechanical ventilation
The secondary outcome is the need for mechanical ventilation between groups
Measured: 15 days after randomization
Number of participants requiring vasoactive drugs
The secondary outcome is the need for vasoactive drugs between groups
Measured: 15 days after randomization
Number of participants requiring renal replacement therapy
The secondary outcome is the need for renal replacement therapy between groups
Measured: 15 days after randomization
Incidence of secondary infection
The secondary outcome is the incidence of secondary infection between groups
Measured: 15 days after randomization
Sequential Organ Failure Assessment (SOFA) score
The secondary outcome is the comparison of Sequential Organ Failure Assessment (SOFA) score between groups
Measured: Baseline and change from baseline to 15 days after randomization
World Health Organization (WHO) COVID-19 score
The secondary outcome is the comparison of World Health Organization (WHO) COVID-19 clinical score between groups
Measured: Baseline and change from baseline to 15 days after randomization
Interleukin 6 (IL-6)
The secondary outcome is the comparison of IL-6 levels between groups
Measured: Baseline and change from baseline to 15 days after randomization
Dimer-D
The secondary outcome is the comparison of dimer-D levels between groups
Measured: Baseline and change from baseline to 15 days after randomization
Chest CT scan
The secondary outcome is the comparison of chest CT scan between groups
Measured: Baseline and change from baseline to 15 days after randomization
Incidence and severity of laboratory alterations
The secondary outcome is the comparison of red blood cells; white blood cells;Platelets; Urea;Creatinine levels between groups
Measured: 30 days after randomization
Clinical side effects
Compare the incidence of clinical significant symptoms (new and persistent stomatitis, vomiting, diarrhea, alopecia, neurotoxicity, bradycardia, hypotension, local pain) reported between groups.
Measured: 30 days after randomization
Other adverse events
Compare the incidence of other adverse events (not expected) between groups
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start27 Oct 2020
- Primary completion15 Mar 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized, double-blind, placebo-controlled, multi-center study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Santa Marcelina
- Responsible party
- Principal investigator, Raul Cavalcante Maranhão, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610567
- Sponsor's protocol ID
- 36746020.5.1001.0068
- Acronym
- Nano-COVID19
- Status last verified
- Jan 2021
- First submitted
- 24 Oct 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu PP, Blet A, Smyth D, Li H. The Science Underlying COVID-19: Implications for the Cardiovascular System. Circulation. 2020 Jul 7;142(1):68-78. doi: 10.1161/CIRCULATIONAHA.120.047549. Epub 2020 Apr 15.
PubMed 32293910Solinas C, Perra L, Aiello M, Migliori E, Petrosillo N. A critical evaluation of glucocorticoids in the management of severe COVID-19. Cytokine Growth Factor Rev. 2020 Aug;54:8-23. doi: 10.1016/j.cytogfr.2020.06.012. Epub 2020 Jun 24.
PubMed 32616381Vinciguerra M, Romiti S, Fattouch K, De Bellis A, Greco E. Atherosclerosis as Pathogenetic Substrate for Sars-Cov2 Cytokine Storm. J Clin Med. 2020 Jul 3;9(7):2095. doi: 10.3390/jcm9072095.
PubMed 32635302Zhang S, Li L, Shen A, Chen Y, Qi Z. Rational Use of Tocilizumab in the Treatment of Novel Coronavirus Pneumonia. Clin Drug Investig. 2020 Jun;40(6):511-518. doi: 10.1007/s40261-020-00917-3.
PubMed 32337664Barbieri LR, Lourenco-Filho DD, Tavares ER, Carvalho PO, Gutierrez PS, Maranhao RC, Stolf NAG. Influence of Drugs Carried in Lipid Nanoparticles in Coronary Disease of Rabbit Transplanted Heart. Ann Thorac Surg. 2017 Aug;104(2):577-583. doi: 10.1016/j.athoracsur.2016.12.044. Epub 2017 Mar 24.
PubMed 28347533Bulgarelli A, Leite AC Jr, Dias AA, Maranhao RC. Anti-atherogenic effects of methotrexate carried by a lipid nanoemulsion that binds to LDL receptors in cholesterol-fed rabbits. Cardiovasc Drugs Ther. 2013 Dec;27(6):531-9. doi: 10.1007/s10557-013-6488-3.
PubMed 24065615Bulgarelli A, Martins Dias AA, Caramelli B, Maranhao RC. Treatment with methotrexate inhibits atherogenesis in cholesterol-fed rabbits. J Cardiovasc Pharmacol. 2012 Apr;59(4):308-14. doi: 10.1097/FJC.0b013e318241c385.
PubMed 22113347Maranhao RC, Tavares ER. Advances in non-invasive drug delivery for atherosclerotic heart disease. Expert Opin Drug Deliv. 2015 Jul;12(7):1135-47. doi: 10.1517/17425247.2015.999663. Epub 2015 Jan 14.
PubMed 25585820Maranhao RC, Guido MC, de Lima AD, Tavares ER, Marques AF, Tavares de Melo MD, Nicolau JC, Salemi VM, Kalil-Filho R. Methotrexate carried in lipid core nanoparticles reduces myocardial infarction size and improves cardiac function in rats. Int J Nanomedicine. 2017 May 17;12:3767-3784. doi: 10.2147/IJN.S129324. eCollection 2017.
PubMed 28553113Shah A, Kashyap R, Tosh P, Sampathkumar P, O'Horo JC. Guide to Understanding the 2019 Novel Coronavirus. Mayo Clin Proc. 2020 Apr;95(4):646-652. doi: 10.1016/j.mayocp.2020.02.003. Epub 2020 Feb 28. No abstract available.
PubMed 32122636Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Mitchell WB. Thromboinflammation in COVID-19 acute lung injury. Paediatr Respir Rev. 2020 Sep;35:20-24. doi: 10.1016/j.prrv.2020.06.004. Epub 2020 Jun 11.
PubMed 32653469Zhou Z, Guo D, Li C, Fang Z, Chen L, Yang R, Li X, Zeng W. Coronavirus disease 2019: initial chest CT findings. Eur Radiol. 2020 Aug;30(8):4398-4406. doi: 10.1007/s00330-020-06816-7. Epub 2020 Mar 24.
PubMed 32211963Cronstein BN. Molecular therapeutics. Methotrexate and its mechanism of action. Arthritis Rheum. 1996 Dec;39(12):1951-60. doi: 10.1002/art.1780391203. No abstract available.
PubMed 8961899
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Phases Clinical Trial to Evaluate Safety and Efficacy of Methotrexate Associated to LDL Like Nanoparticles (LDE-MTX) in the Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease.
- ClinicalTrials.gov ID
- NCT04610567
- Acronym / sponsor ID
- Nano-COVID19 / 36746020.5.1001.0068
- Conditions
- Coronavirus, Inflammation, Covid19
- Keywords
- coronavirus, inflammation, nanoparticles, methotrexate, covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Hospital Santa Marcelina
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 30 Oct 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 investigators propose a prospective, randomized, double-blind, placebo-controlled study, conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed with mild Coronavirus-19(COVID-19) disease.
A total of 100 patients will be randomized to receive MTX-LDE or placebo each 7 days, up to 3 times, during in hospital treatment.
Detailed description
The objective of the study is to evaluate the safety and efficacy of (MTX -LDE) in patients with mild Coronavirus-19 (COVID-19) disease.
In phase 1, firstly 3 patients with moderate COVID-19 disease will receive MTX-LDE IV 15mg each 7 days, up to 3 times, during hospitalization. After that, 9 patients with moderate COVID-19 disease will receive MTX-LDE IV 30mg each 7 days, up to 3 times, during hospitalization. Follow-up assessments will occur daily following randomization during in hospital treatment and 2 weeks after discharge for evaluation of the occurrence of adverse events.The purpose of this phase will be evaluate safety and pharmacokinetics.
If no objection by data and safety monitoring board (DSMB), will be authorized to start the second phase.
In phase 2, 88 patients with moderate COVID-19 disease will be randomized to receive MTX-LDE IV 30mg or placebo-LDE IV each 7 days, up to 3 times, during hospitalization. Follow-up assessments will occur daily following randomization during in hospital treatment and 2 weeks after discharge for evaluation of the occurrence of any trial endpoints or other adverse events.The primary endpoint of this phase will be reduction in duration of hospitalization stay between groups.
Patients will undergo clinical and laboratory safety evaluations daily. An algorithm for drug suspension based on clinical and laboratory finding will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a randomized, double-blind, placebo-controlled, multi-center study.
| Arm | Type | Receives |
|---|---|---|
| MTX-LDE phase 1 | Experimental | Drug: Methotrexate-LDE phase 1Methotrexate carried by a lipid nanoparticle (MTX-LDE) |
| MTX-LDE phase 2 | Experimental | Drug: Methotrexate-LDE phase 2Methotrexate carried by a lipid nanoparticle (MTX-LDE) |
| Placebo-LDE phase 2 | Placebo comparator | Drug: Placebo-LDE phase 2Lipid nanoparticle (LDE) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who were hospitalized with confirmed COVID-19
- Mild Coronavirus-19 disease (WHO Coronavirus-19 scale < 5)
- Fewer than 14 days since symptom onset.
- Female patient is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile.
- Female patient is of childbearing potential must has a negative pregnancy test.
Key exclusion criteria (19 listed)
- Need for oxygen supplementation >4 L/min via nasal cannula or ≥40% via Venturi mask.
- Need for oxygen supplementation via high-flow nasal cannula.
- Need for invasive mechanical ventilation.
- Extent of pulmonary involvement > 50% by CT scan.
- Chronic renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m2)
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 |
|---|---|---|
| Methotrexate-LDE phase 1Also: MTX-LDE phase 13 patients will receive MTX-LDE at the dose of 15mg IV each 7 days during hospitalization, up to 3 times . After that, 9 patients will receive MTX-LDE at the dose of 30mg IV each 7 days during hospitalization, up to 3 times . All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of MTX-LDE | Drug | MTX-LDE phase 1 |
| Methotrexate-LDE phase 2Also: MTX-LDE phase 244 patients will receive MTX-LDE at the dose of 30mg IV each 7 days during hospitalization, up to 3 times dose of 30mg IV each 7 days during hospitalization, up to 3 times . All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of MTX-LDE | Drug | MTX-LDE phase 2 |
| Placebo-LDE phase 244 patients will receive Placebo-LDE IV each 7 days during hospitalization, up to 3 times dose of 30mg IV each 7 days during hospitalization, up to 3 times . All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of Placebo-LDE | Drug | Placebo-LDE phase 2 |
Primary outcome
Duration of hospital stay
Time frame: 30 days after randomization
Compare the duration of hospital stay between groups
12 secondary outcomes
Number of participants requiring mechanical ventilation
Time frame: 15 days after randomization
Number of participants requiring vasoactive drugs
Time frame: 15 days after randomization
Number of participants requiring renal replacement therapy
Time frame: 15 days after randomization
Incidence of secondary infection
Time frame: 15 days after randomization
Sequential Organ Failure Assessment (SOFA) score
Time frame: Baseline and change from baseline to 15 days after randomization
World Health Organization (WHO) COVID-19 score
Time frame: Baseline and change from baseline to 15 days after randomization
Interleukin 6 (IL-6)
Time frame: Baseline and change from baseline to 15 days after randomization
Dimer-D
Time frame: Baseline and change from baseline to 15 days after randomization
Chest CT scan
Time frame: Baseline and change from baseline to 15 days after randomization
Incidence and severity of laboratory alterations
Time frame: 30 days after randomization
Clinical side effects
Time frame: 30 days after randomization
Other adverse events
Time frame: 30 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 32293910Liu PP, Blet A, Smyth D, Li H. The Science Underlying COVID-19: Implications for the Cardiovascular System. Circulation. 2020 Jul 7;142(1):68-78. doi: 10.1161/CIRCULATIONAHA.120.047549. Epub 2020 Apr 15.
- Background: PubMed 32616381Solinas C, Perra L, Aiello M, Migliori E, Petrosillo N. A critical evaluation of glucocorticoids in the management of severe COVID-19. Cytokine Growth Factor Rev. 2020 Aug;54:8-23. doi: 10.1016/j.cytogfr.2020.06.012. Epub 2020 Jun 24.
- Background: PubMed 32635302Vinciguerra M, Romiti S, Fattouch K, De Bellis A, Greco E. Atherosclerosis as Pathogenetic Substrate for Sars-Cov2 Cytokine Storm. J Clin Med. 2020 Jul 3;9(7):2095. doi: 10.3390/jcm9072095.
- Background: PubMed 32337664Zhang S, Li L, Shen A, Chen Y, Qi Z. Rational Use of Tocilizumab in the Treatment of Novel Coronavirus Pneumonia. Clin Drug Investig. 2020 Jun;40(6):511-518. doi: 10.1007/s40261-020-00917-3.
- Background: PubMed 28347533Barbieri LR, Lourenco-Filho DD, Tavares ER, Carvalho PO, Gutierrez PS, Maranhao RC, Stolf NAG. Influence of Drugs Carried in Lipid Nanoparticles in Coronary Disease of Rabbit Transplanted Heart. Ann Thorac Surg. 2017 Aug;104(2):577-583. doi: 10.1016/j.athoracsur.2016.12.044. Epub 2017 Mar 24.
- Background: PubMed 24065615Bulgarelli A, Leite AC Jr, Dias AA, Maranhao RC. Anti-atherogenic effects of methotrexate carried by a lipid nanoemulsion that binds to LDL receptors in cholesterol-fed rabbits. Cardiovasc Drugs Ther. 2013 Dec;27(6):531-9. doi: 10.1007/s10557-013-6488-3.
- Background: PubMed 22113347Bulgarelli A, Martins Dias AA, Caramelli B, Maranhao RC. Treatment with methotrexate inhibits atherogenesis in cholesterol-fed rabbits. J Cardiovasc Pharmacol. 2012 Apr;59(4):308-14. doi: 10.1097/FJC.0b013e318241c385.
- Background: PubMed 25585820Maranhao RC, Tavares ER. Advances in non-invasive drug delivery for atherosclerotic heart disease. Expert Opin Drug Deliv. 2015 Jul;12(7):1135-47. doi: 10.1517/17425247.2015.999663. Epub 2015 Jan 14.
- Background: PubMed 28553113Maranhao RC, Guido MC, de Lima AD, Tavares ER, Marques AF, Tavares de Melo MD, Nicolau JC, Salemi VM, Kalil-Filho R. Methotrexate carried in lipid core nanoparticles reduces myocardial infarction size and improves cardiac function in rats. Int J Nanomedicine. 2017 May 17;12:3767-3784. doi: 10.2147/IJN.S129324. eCollection 2017.
- Results publication: PubMed 32122636Shah A, Kashyap R, Tosh P, Sampathkumar P, O'Horo JC. Guide to Understanding the 2019 Novel Coronavirus. Mayo Clin Proc. 2020 Apr;95(4):646-652. doi: 10.1016/j.mayocp.2020.02.003. Epub 2020 Feb 28. No abstract available.
- Results publication: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Results publication: PubMed 32653469Mitchell WB. Thromboinflammation in COVID-19 acute lung injury. Paediatr Respir Rev. 2020 Sep;35:20-24. doi: 10.1016/j.prrv.2020.06.004. Epub 2020 Jun 11.
- WHO COVID-19 Therapeutic Trial SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
3 sites 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-LDE phase 1 and Methotrexate-LDE phase 2 in people with Coronavirus and Inflammation, run by University of Sao Paulo General Hospital at 3 sites 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 6 inclusion and 19 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 Raul Maranhão, MD;PhD (+551126615951, raul.maranhao@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610567, which also lists 14 linked publications.
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 14 Jan 2021.