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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04619290
Study type Interventional
Source Hospital Reg. Lic. Adolfo Lopez Mateos
Contact Martha E. Rodríguez Arellano, MD
Phone 52 5512999131
Email marthaeunicer@yahoo.com.mx
Status Recruiting
Phase Phase 1
Start date October 12, 2020
Completion date December 30, 2020