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Outpatient Treatment With CoVid-19 With Prexablu

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ClinicalTrials.gov Identifier: NCT04619290
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos

Tracking Information
First Submitted Date  ICMJE November 4, 2020
First Posted Date  ICMJE November 6, 2020
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE October 12, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2020)
  • 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
  • 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.
  • 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
  • Change Form Baseline in Ferritin levels [ Time Frame: up to 7 days ]
    Blood samples to analyse Ferritin levels
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outpatient Treatment With CoVid-19 With Prexablu
Official Title  ICMJE Treatment in Outpatient Patients With Covid-19 With Methylene Blue and Photodynamic
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

  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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single group comparison with contemporaneous conventionally treated patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sars Cov 2
Intervention  ICMJE
  • 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.
  • Other: Control patients
    Control patients will be received the conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Sublingual Methylene blue
  • 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
    Intervention: Other: Control patients
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2020)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Martha E. Rodríguez Arellano, MD 52 5512999131 marthaeunicer@yahoo.com.mx
Contact: Robin Messier +18184343667 robbin.messier@i-wellnessnetwork.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04619290
Other Study ID Numbers  ICMJE 064.I.2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos
Study Sponsor  ICMJE Hospital Reg. Lic. Adolfo Lopez Mateos
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Reg. Lic. Adolfo Lopez Mateos
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP