Sars Cov 2Phase 1NCT04619290
Outpatient Treatment With CoVid-19 With Prexablu
A Phase 1 study testing Sublingual Methylene blue in people with Sars Cov 2, run by Hospital Reg. Lic. Adolfo Lopez Mateos at 1 site in Mexico.
Trial summary
Within the epidemic context of phase 3 in Mexico, the implementation of new treatments that have been shown to be beneficial for patients in other countries is an urgent need. Methylene blue (MB, the oxidized form, blue color) has been used in many different clinical medicine areas, ranging from malaria to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars Cov 2
- What is being tested?
- Sublingual Methylene blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 12 Oct 2020to 30 Dec 2020
- Phase
- Phase 1
- 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
- Patients over 18 years of age
- Of both sexes
- Confirmed case of Covid-19 (by RT-PCR) and CT less than 32 in the E
- That they go to the ER service due to COVID symptoms, and that they voluntarily agree to participate in the study by written the informed consent
- With at least 1 of the following symptoms: fever, headache, nausea, dyspnea, myalgia, vomiting, or diarrhea
- With chest X-ray without pneumonia criteria
Show all 9Show fewer
- With SO2> 90
- No history of allergic reaction to methylene blue
- No history of treatment with medication with methylene blue negative interaction
Who cannot join
- Pregnancy and breastfeeding
- Preadmission anticoagulation
- Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
- Active chronic hepatitis
- Patients with history of allergic reaction or significant sensitivity to methylene blue
- Treatment with immunosuppressive agents
Show all 12Show fewer
- Diagnosis of cancer at any stage and of any type.
- Pregnancy and breastfeeding
- Patients who plan to become pregnant during the study period or within 6 months after the end of the study period.
- Participation in another clinical trial with an experimental drug in the last 30 days.
- Other pathologies that, in the medical opinion, contraindicate participation in the study.
- Uncompensated comorbidities
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Regional Lic Adolfo Lopez Mateos
Mexico City, Ciudad de Mexico CDMX (Mexico City), 01030
Martha E. Rodríguez Arellano, MD, +52 5512999131, marthaeunicer@yahoo.com.mx
Paula Costa Urrutia, PhD, +52 5530395269, paula.costa.urrutia@gmail.com
About this study
Official title: Treatment in Outpatient Patients With Covid-19 With Methylene Blue and Photodynamic
Within the epidemic context of phase 3 in Mexico, the implementation of new treatments that have been shown to be beneficial for patients in other countries is an urgent need. Methylene blue (MB, the oxidized form, blue color) has been used in many different clinical medicine areas, ranging from malaria to orthopedics. Methylene blue absorbs energy directly from a light source and then transfers this energy to molecules of oxygen creating singlet oxygen (O2), which is the first electronic excited state of molecular oxygen (O2). Singlet oxygen is extremely electrophilic; thus, it can directly oxidize electron-rich double bonds in biological molecules and macromolecules. For this reason, methylene blue has been used as a photosensitizer in the treatment of cancer and the protection of serum from viral agents. Methylene blue can be reactivated using energy from a light source in the body until processed out through the kidneys.
Read the detailed description
Patients diagnosed with COVID-19 and confirmed positive with the virus by PCR will be treated with Prexablu for seven days. The administration is Sublingual 1 ml Prexablu once a day and PDT for 1 hour daily x 7 days. Days to clinical improvement to be evaluated for seven days considering temperature and other vital signs measurement, arterial oxygen saturation.
- On day one and day seven a blood sample will be drawn to assess chemistry (including liver function tests), C reactive protein, IgG, IgM, IL-6, erythrocyte sedimentation rates like procalcitonin, ferritin levels, and the D dimer II. Daily PCR Swabs measuring cycle threshold (CT) will be collected (days 1 - 7) III. Daily 1ml Prexablu will be placed sublingual
- Prexablu activated for 10 minutes with Low Level Light Therapy (670 nm light) before being placed sublingually.
- Low Level Light Therapy (NocUlite device) will be placed on wrist for 50 minutes.
- Conditions
- Sars Cov 2
- Being tested
- Sublingual Methylene blue, Control patients
- Keywords
- COVID-19, methylene blue, photodynamic interval therapy, outpatient, Mexico
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual Methylene blueDrug
Patients will be received the treatment as follow: it will be placed Low Level Light Therapy (LLLT) NocUlite on the ventral side of the wrist on full power. Draw out 1ml of diluted Prexablu into a syringe. Activate this syringe LLLT device for 10 minutes. Then place 1ml of this activated solution of Prexablu sublingually. Patients must keep the solution under the tongue for 10 minutes before swallowing. Keep wrist pads on patients for 50 minutes.
Control patientsOther
Control patients will be received the conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
| Study group | Role | What they receive |
|---|---|---|
| Methylene blue treated group | Experimental | Patients will be included in this group with the following symptoms: with at least one of the following symptoms: headache, nausea, dyspnea, myalgia, vomiting. Also that they meet the inclusion criteria Receives: Drug: Sublingual Methylene blue |
| Conventionally treated group | Active comparator | Patients will be included in this group with the following symptoms: with at least one of the following symptoms: headache, nausea, dyspnea, myalgia, vomiting. Also that they meet the inclusion criteria Receives: Other: Control patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form baseline in Arterial oxygen saturation
Aretrial oxygen saturation will be taken by an oximeter
Measured: up to 7 days
Days to clinical improvement
Number of days of patient discharge
Measured: up to 7 days
Secondary outcomes (5)
Change Form Baseline in C reactive protein at 7 days
Blood samples will be taken on days 1 and 7
Measured: up to 7 days
Change Form Baseline in IL-1β
Blood samples to analyse IL-1β will be taken on days 1 and 7.
Measured: up to 7 days
Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin
Blood samples to analyse the Erythrocyte sedimentation rate like procalcitonin
Measured: up to 7 days
Change Form Baseline in Ferritin levels
Blood samples to analyse Ferritin levels
Measured: up to 7 days
Change Form Baseline in D dimer
Blood samples to analyse D dimer will be taken on days 1 and 7
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start12 Oct 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Sars Cov 2Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single group comparison with contemporaneous conventionally treated patients.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Reg. Lic. Adolfo Lopez Mateos
- Sponsor type
- Other government
- Responsible party
- Principal investigator, M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619290
- Sponsor's protocol ID
- 064.I.2020
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Ji W, Wang W, Zhao X, Zai J, Li X. Cross-species transmission of the newly identified coronavirus 2019-nCoV. J Med Virol. 2020 Apr;92(4):433-440. doi: 10.1002/jmv.25682.
PubMed 31967321Baud D, Qi X, Nielsen-Saines K, Musso D, Pomar L, Favre G. Real estimates of mortality following COVID-19 infection. Lancet Infect Dis. 2020 Jul;20(7):773. doi: 10.1016/S1473-3099(20)30195-X. Epub 2020 Mar 12. No abstract available.
PubMed 32171390Backer JA, Klinkenberg D, Wallinga J. Incubation period of 2019 novel coronavirus (2019-nCoV) infections among travellers from Wuhan, China, 20-28 January 2020. Euro Surveill. 2020 Feb;25(5):2000062. doi: 10.2807/1560-7917.ES.2020.25.5.2000062.
PubMed 32046819Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.
PubMed 32159775Oz M, Lorke DE, Hasan M, Petroianu GA. Cellular and molecular actions of Methylene Blue in the nervous system. Med Res Rev. 2011 Jan;31(1):93-117. doi: 10.1002/med.20177.
PubMed 19760660Bradberry SM. Occupational methaemoglobinaemia. Mechanisms of production, features, diagnosis and management including the use of methylene blue. Toxicol Rev. 2003;22(1):13-27. doi: 10.2165/00139709-200322010-00003.
PubMed 14579544Barbosa P, Peters TM. The effects of vital dyes on living organisms with special reference to methylene blue and neutral red. Histochem J. 1971 Jan;3(1):71-93. doi: 10.1007/BF01686508. No abstract available.
PubMed 4106597Wainwright M, Crossley KB. Methylene Blue--a therapeutic dye for all seasons? J Chemother. 2002 Oct;14(5):431-43. doi: 10.1179/joc.2002.14.5.431.
PubMed 12462423Lee SK, Mills A. Novel photochemistry of leuco-Methylene Blue. Chem Commun (Camb). 2003 Sep 21;(18):2366-7. doi: 10.1039/b307228b.
PubMed 14518917Khan S, Alam F, Azam A, Khan AU. Gold nanoparticles enhance methylene blue-induced photodynamic therapy: a novel therapeutic approach to inhibit Candida albicans biofilm. Int J Nanomedicine. 2012;7:3245-57. doi: 10.2147/IJN.S31219. Epub 2012 Jun 29.
PubMed 22802686Wainwright M. Methylene blue derivatives--suitable photoantimicrobials for blood product disinfection? Int J Antimicrob Agents. 2000 Dec;16(4):381-94. doi: 10.1016/s0924-8579(00)00207-7.
PubMed 11118846Tardivo JP, Del Giglio A, de Oliveira CS, Gabrielli DS, Junqueira HC, Tada DB, Severino D, de Fatima Turchiello R, Baptista MS. Methylene blue in photodynamic therapy: From basic mechanisms to clinical applications. Photodiagnosis Photodyn Ther. 2005 Sep;2(3):175-91. doi: 10.1016/S1572-1000(05)00097-9. Epub 2005 Nov 21.
PubMed 25048768Tuite EM, Kelly JM. Photochemical interactions of methylene blue and analogues with DNA and other biological substrates. J Photochem Photobiol B. 1993 Dec;21(2-3):103-24. doi: 10.1016/1011-1344(93)80173-7.
PubMed 8301408Eickmann M, Gravemann U, Handke W, Tolksdorf F, Reichenberg S, Muller TH, Seltsam A. Inactivation of Ebola virus and Middle East respiratory syndrome coronavirus in platelet concentrates and plasma by ultraviolet C light and methylene blue plus visible light, respectively. Transfusion. 2018 Sep;58(9):2202-2207. doi: 10.1111/trf.14652. Epub 2018 May 6.
PubMed 29732571
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment in Outpatient Patients With Covid-19 With Methylene Blue and Photodynamic
- ClinicalTrials.gov ID
- NCT04619290
- Acronym / sponsor ID
- 064.I.2020
- Conditions
- Sars Cov 2
- Keywords
- COVID-19, methylene blue, photodynamic interval therapy, outpatient, Mexico
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospital Reg. Lic. Adolfo Lopez MateosOther government
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 6 Nov 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.
Within the epidemic context of phase 3 in Mexico, the implementation of new treatments that have been shown to be beneficial for patients in other countries is an urgent need. Methylene blue (MB, the oxidized form, blue color) has been used in many different clinical medicine areas, ranging from malaria to orthopedics. Methylene blue absorbs energy directly from a light source and then transfers this energy to molecules of oxygen creating singlet oxygen (O2), which is the first electronic excited state of molecular oxygen (O2). Singlet oxygen is extremely electrophilic; thus, it can directly oxidize electron-rich double bonds in biological molecules and macromolecules. For this reason, methylene blue has been used as a photosensitizer in the treatment of cancer and the protection of serum from viral agents. Methylene blue can be reactivated using energy from a light source in the body until processed out through the kidneys.
Detailed description
Patients diagnosed with COVID-19 and confirmed positive with the virus by PCR will be treated with Prexablu for seven days. The administration is Sublingual 1 ml Prexablu once a day and PDT for 1 hour daily x 7 days. Days to clinical improvement to be evaluated for seven days considering temperature and other vital signs measurement, arterial oxygen saturation.
- On day one and day seven a blood sample will be drawn to assess chemistry (including liver function tests), C reactive protein, IgG, IgM, IL-6, erythrocyte sedimentation rates like procalcitonin, ferritin levels, and the D dimer II. Daily PCR Swabs measuring cycle threshold (CT) will be collected (days 1 - 7) III. Daily 1ml Prexablu will be placed sublingual
- Prexablu activated for 10 minutes with Low Level Light Therapy (670 nm light) before being placed sublingually.
- Low Level Light Therapy (NocUlite device) will be placed on wrist for 50 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single group comparison with contemporaneous conventionally treated patients.
| Arm | Type | Receives |
|---|---|---|
| Methylene blue treated group | Experimental | Drug: Sublingual Methylene bluePatients will be included in this group with the following symptoms: with at least one of the following symptoms: headache, nausea, dyspnea, myalgia, vomiting. Also that they meet the inclusion criteria |
| Conventionally treated group | Active comparator | Other: Control patientsPatients will be included in this group with the following symptoms: with at least one of the following symptoms: headache, nausea, dyspnea, myalgia, vomiting. Also that they meet the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients over 18 years of age
- Of both sexes
- Confirmed case of Covid-19 (by RT-PCR) and CT less than 32 in the E
- That they go to the ER service due to COVID symptoms, and that they voluntarily agree to participate in the study by written the informed consent
- With at least 1 of the following symptoms: fever, headache, nausea, dyspnea, myalgia, vomiting, or diarrhea
Key exclusion criteria (12 listed)
- Pregnancy and breastfeeding
- Preadmission anticoagulation
- Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
- Active chronic hepatitis
- Patients with history of allergic reaction or significant sensitivity to methylene blue
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 |
|---|---|---|
| Sublingual Methylene bluePatients will be received the treatment as follow: it will be placed Low Level Light Therapy (LLLT) NocUlite on the ventral side of the wrist on full power. Draw out 1ml of diluted Prexablu into a syringe. Activate this syringe LLLT device for 10 minutes. Then place 1ml of this activated solution of Prexablu sublingually. Patients must keep the solution under the tongue for 10 minutes before swallowing. Keep wrist pads on patients for 50 minutes. | Drug | Methylene blue treated group |
| Control patientsControl patients will be received the conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant. | Other | Conventionally treated group |
Primary outcome
Change form baseline in Arterial oxygen saturation
Time frame: up to 7 days
Aretrial oxygen saturation will be taken by an oximeter
Days to clinical improvement
Time frame: up to 7 days
Number of days of patient discharge
5 secondary outcomes
Change Form Baseline in C reactive protein at 7 days
Time frame: up to 7 days
Change Form Baseline in IL-1β
Time frame: up to 7 days
Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin
Time frame: up to 7 days
Change Form Baseline in Ferritin levels
Time frame: up to 7 days
Change Form Baseline in D dimer
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 31967321Ji W, Wang W, Zhao X, Zai J, Li X. Cross-species transmission of the newly identified coronavirus 2019-nCoV. J Med Virol. 2020 Apr;92(4):433-440. doi: 10.1002/jmv.25682.
- Background: PubMed 32171390Baud D, Qi X, Nielsen-Saines K, Musso D, Pomar L, Favre G. Real estimates of mortality following COVID-19 infection. Lancet Infect Dis. 2020 Jul;20(7):773. doi: 10.1016/S1473-3099(20)30195-X. Epub 2020 Mar 12. No abstract available.
- Background: PubMed 32046819Backer JA, Klinkenberg D, Wallinga J. Incubation period of 2019 novel coronavirus (2019-nCoV) infections among travellers from Wuhan, China, 20-28 January 2020. Euro Surveill. 2020 Feb;25(5):2000062. doi: 10.2807/1560-7917.ES.2020.25.5.2000062.
- Background: PubMed 32159775Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.
- Background: PubMed 19760660Oz M, Lorke DE, Hasan M, Petroianu GA. Cellular and molecular actions of Methylene Blue in the nervous system. Med Res Rev. 2011 Jan;31(1):93-117. doi: 10.1002/med.20177.
- Background: PubMed 14579544Bradberry SM. Occupational methaemoglobinaemia. Mechanisms of production, features, diagnosis and management including the use of methylene blue. Toxicol Rev. 2003;22(1):13-27. doi: 10.2165/00139709-200322010-00003.
- Background: PubMed 4106597Barbosa P, Peters TM. The effects of vital dyes on living organisms with special reference to methylene blue and neutral red. Histochem J. 1971 Jan;3(1):71-93. doi: 10.1007/BF01686508. No abstract available.
- Background: PubMed 12462423Wainwright M, Crossley KB. Methylene Blue--a therapeutic dye for all seasons? J Chemother. 2002 Oct;14(5):431-43. doi: 10.1179/joc.2002.14.5.431.
- Background: PubMed 14518917Lee SK, Mills A. Novel photochemistry of leuco-Methylene Blue. Chem Commun (Camb). 2003 Sep 21;(18):2366-7. doi: 10.1039/b307228b.
- Background: PubMed 22802686Khan S, Alam F, Azam A, Khan AU. Gold nanoparticles enhance methylene blue-induced photodynamic therapy: a novel therapeutic approach to inhibit Candida albicans biofilm. Int J Nanomedicine. 2012;7:3245-57. doi: 10.2147/IJN.S31219. Epub 2012 Jun 29.
- Background: PubMed 11118846Wainwright M. Methylene blue derivatives--suitable photoantimicrobials for blood product disinfection? Int J Antimicrob Agents. 2000 Dec;16(4):381-94. doi: 10.1016/s0924-8579(00)00207-7.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sublingual Methylene blue in people with Sars Cov 2, run by Hospital Reg. Lic. Adolfo Lopez Mateos at 1 site in Mexico.
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 9 inclusion and 12 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 12 Nov 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 Mexico. 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 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.
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 Martha E. Rodríguez Arellano, MD (52 5512999131, marthaeunicer@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change form baseline in Arterial oxygen saturation (time frame: up to 7 days). The study lists 2 primary outcomes in all. 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 NCT04619290, which also lists 28 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 12 Nov 2020.