Outpatient Treatment With CoVid-19 With Prexablu

Sponsor

Hospital Reg. Lic. Adolfo Lopez Mateos (Other)

Overall Status

Recruiting

CT.gov ID

NCT04619290

Collaborator

(none)

Enrollment

Location

Arms

2.6

Anticipated Duration (Months)

17.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sars Cov 2	Drug: Sublingual Methylene blue Other: Control patients	Phase 1

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

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single group comparison with contemporaneous conventionally treated patients.Single group comparison with contemporaneous conventionally treated patients.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment in Outpatient Patients With Covid-19 With Methylene Blue and Photodynamic

Actual Study Start Date :

Oct 12, 2020

Anticipated Primary Completion Date :

Nov 30, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

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.

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

Other: Control patients

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

Outcome Measures

Primary Outcome Measures

Change form baseline in Arterial oxygen saturation [up to 7 days]
Aretrial oxygen saturation will be taken by an oximeter
Days to clinical improvement [up to 7 days]
Number of days of patient discharge

Secondary Outcome Measures

Change Form Baseline in C reactive protein at 7 days [up to 7 days]
Blood samples will be taken on days 1 and 7
Change Form Baseline in IL-1β [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 [up to 7 days]
Blood samples to analyse the Erythrocyte sedimentation rate like procalcitonin
Change Form Baseline in Ferritin levels [up to 7 days]
Blood samples to analyse Ferritin levels
Change Form Baseline in D dimer [up to 7 days]
Blood samples to analyse D dimer will be taken on days 1 and 7

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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