Back to resultsOutpatient Treatment With CoVid-19 With Prexablu
Primary Purpose
Sars Cov 2
Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Sublingual Methylene blue
Control patients
Sponsored by
About this trial
This is an interventional treatment trial for Sars Cov 2 focused on measuring COVID-19, methylene blue, photodynamic interval therapy, outpatient, Mexico
Eligibility Criteria
Inclusion Criteria:
- 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
- With SO2> 90
- No history of allergic reaction to methylene blue
- No history of treatment with medication with methylene blue negative interaction
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Hospital Regional Lic Adolfo Lopez MateosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methylene blue treated group
Conventionally treated group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change form baseline in Arterial oxygen saturation
Aretrial oxygen saturation will be taken by an oximeter
Days to clinical improvement
Number of days of patient discharge
Secondary Outcome Measures
Change Form Baseline in C reactive protein at 7 days
Blood samples will be taken on days 1 and 7
Change Form Baseline in IL-1β
Blood samples to analyse IL-1β will be taken on days 1 and 7.
Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin
Blood samples to analyse the Erythrocyte sedimentation rate like procalcitonin
Change Form Baseline in Ferritin levels
Blood samples to analyse Ferritin levels
Change Form Baseline in D dimer
Blood samples to analyse D dimer will be taken on days 1 and 7
Full Information
NCT ID
NCT04619290
First Posted
November 4, 2020
Last Updated
November 9, 2020
Sponsor
Hospital Reg. Lic. Adolfo Lopez Mateos
1. Study Identification
Unique Protocol Identification Number
NCT04619290
Brief Title
Outpatient Treatment With CoVid-19 With Prexablu
Official Title
Treatment in Outpatient Patients With Covid-19 With Methylene Blue and Photodynamic
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Reg. Lic. Adolfo Lopez Mateos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
I. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars Cov 2
Keywords
COVID-19, methylene blue, photodynamic interval therapy, outpatient, Mexico
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Single group comparison with contemporaneous conventionally treated patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylene blue treated group
Arm Type
Experimental
Arm Description
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
Arm Title
Conventionally treated group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sublingual Methylene blue
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control patients
Intervention Description
Control patients will be received the conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
Primary Outcome Measure Information:
Title
Change form baseline in Arterial oxygen saturation
Description
Aretrial oxygen saturation will be taken by an oximeter
Time Frame
up to 7 days
Title
Days to clinical improvement
Description
Number of days of patient discharge
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Change Form Baseline in C reactive protein at 7 days
Description
Blood samples will be taken on days 1 and 7
Time Frame
up to 7 days
Title
Change Form Baseline in IL-1β
Description
Blood samples to analyse IL-1β will be taken on days 1 and 7.
Time Frame
up to 7 days
Title
Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin
Description
Blood samples to analyse the Erythrocyte sedimentation rate like procalcitonin
Time Frame
up to 7 days
Title
Change Form Baseline in Ferritin levels
Description
Blood samples to analyse Ferritin levels
Time Frame
up to 7 days
Title
Change Form Baseline in D dimer
Description
Blood samples to analyse D dimer will be taken on days 1 and 7
Time Frame
up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
With SO2> 90
No history of allergic reaction to methylene blue
No history of treatment with medication with methylene blue negative interaction
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha E. Rodríguez Arellano, MD
Phone
52 5512999131
Email
marthaeunicer@yahoo.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Messier
Phone
+18184343667
Email
robbin.messier@i-wellnessnetwork.com
Facility Information:
Facility Name
Hospital Regional Lic Adolfo Lopez Mateos
City
Mexico City
State/Province
Ciudad De Mexico CDMX (Mexico City)
ZIP/Postal Code
01030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha E. Rodríguez Arellano, MD
Phone
+52 5512999131
Email
marthaeunicer@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Paula Costa Urrutia, PhD
Phone
+52 5530395269
Email
paula.costa.urrutia@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Outpatient Treatment With CoVid-19 With Prexablu
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