Outpatient Treatment With CoVid-19 With Prexablu

What Was Tested

The trial (phase 1) is built around Methylene blue (non-peptide stack partner).

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).

It had two arms (groups): Methylene blue treated group (experimental) and Conventionally treated group (active comparator).

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.

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.

The registry classes the interventions as drug and other.

More on the Plan

Patients diagnosed with COVID-19 and confirmed positive with the virus by PCR will be treated with Prexablu for seven days.

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.

Prexablu activated for 10 minutes with Low Level Light Therapy (670 nm light) before being placed sublingually. 2.

Who Took Part

46 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: pregnancy and breastfeeding; preadmission anticoagulation; active chronic hepatitis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

It started in 2020-10-12 with completion listed for 2020-11-30.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change form baseline in Arterial oxygen saturation (time frame: up to 7 days).

It also tracked 5 secondary outcomes, for example Change Form Baseline in C reactive protein at 7 days, Change Form Baseline in IL-1β, Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin, Change Form Baseline in Ferritin levels and Change Form Baseline in D dimer.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 46 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.