Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04619290
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-11-04
Brief Title:
Outpatient Treatment With CoVid-19 With Prexablu
Sponsor:
Hospital Reg Lic Adolfo Lopez Mateos
Organization:
Hospital Reg Lic Adolfo Lopez Mateos
Study Overview
Official Title:
Treatment in Outpatient Patients With Covid-19 With Methylene Blue and Photodynamic
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None