NCT04619290

Outpatient Treatment With CoVid-19 With Prexablu

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Hospital Reg. Lic. Adolfo Lopez Mateos · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sars Cov 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-12
• Primary completion: 2020-11-30
• Completion: 2020-12-30
• First posted: 2020-11-06
• Last updated: 2020-11-12

Locations

1 site across 1 country: Mexico