Outpatient Treatment With CoVid-19 With Prexablu

NCT04619290 | Unknown Phase 1 DMC

• 1 other identifier: 064.I.2020
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars Cov 2

Keywords

COVID-19; methylene blue; photodynamic interval therapy; outpatient; Mexico

Outcome Measures

Primary Outcomes (2)

• Change form baseline in Arterial oxygen saturation

  Aretrial oxygen saturation will be taken by an oximeter

  up to 7 days

• Days to clinical improvement

  Number of days of patient discharge

  up to 7 days

Secondary Outcomes (5)

• Change Form Baseline in C reactive protein at 7 days

  up to 7 days

• Change Form Baseline in IL-1β

  up to 7 days

• Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin

  up to 7 days

• Change Form Baseline in Ferritin levels

  up to 7 days

• Change Form Baseline in D dimer

  up to 7 days

Study Arms (2)

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

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

Other: Control patients

Interventions

Sublingual Methylene blue DRUG

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.

Methylene blue treated group

Control patients OTHER

Control patients will be received the conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.

Conventionally treated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Reg. Lic. Adolfo Lopez Mateos: lead

Study Sites (1)

Hospital Regional Lic Adolfo Lopez Mateos

Mexico City, Ciudad de Mexico CDMX (Mexico City), 01030, Mexico

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Martha E. Rodríguez Arellano, MD

CONTACT

52 5512999131; marthaeunicer@yahoo.com.mx

Robin Messier

CONTACT

+18184343667; robbin.messier@i-wellnessnetwork.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group comparison with contemporaneous conventionally treated patients.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 6, 2020
• Study Start: October 12, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)