Outpatient Treatment With CoVid-19 With Prexablu

November 9, 2020 updated by: M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

  1. Prexablu activated for 10 minutes with Low Level Light Therapy (670 nm light) before being placed sublingually.
  2. Low Level Light Therapy (NocUlite device) will be placed on wrist for 50 minutes.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ciudad De Mexico CDMX (Mexico City)
      • Mexico City, Ciudad De Mexico CDMX (Mexico City), Mexico, 01030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylene blue treated group
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
Drug: Sublingual Methylene blue
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.
Active Comparator: Conventionally treated group
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
Other: Control patients
Control patients will be received the conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change form baseline in Arterial oxygen saturation
Time Frame: up to 7 days
Aretrial oxygen saturation will be taken by an oximeter
up to 7 days
Days to clinical improvement
Time Frame: up to 7 days
Number of days of patient discharge
up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Form Baseline in C reactive protein at 7 days
Time Frame: up to 7 days
Blood samples will be taken on days 1 and 7
up to 7 days
Change Form Baseline in IL-1β
Time Frame: up to 7 days
Blood samples to analyse IL-1β will be taken on days 1 and 7.
up to 7 days
Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin
Time Frame: up to 7 days
Blood samples to analyse the Erythrocyte sedimentation rate like procalcitonin
up to 7 days
Change Form Baseline in Ferritin levels
Time Frame: up to 7 days
Blood samples to analyse Ferritin levels
up to 7 days
Change Form Baseline in D dimer
Time Frame: up to 7 days
Blood samples to analyse D dimer will be taken on days 1 and 7
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Reg. Lic. Adolfo Lopez Mateos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 064.I.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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