Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.

It had three arms (groups): Exchange transfusion (experimental), Methylene blue with plasma (experimental) and Exchange transfusion and methylene blue with plasma (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

Study Tools AND/ OR procedure The patients were subjected to the following: Clinical parameters: Complete history taking and thorough clinical examination 1.

CBC with differential counts. 3.

Blood film for shistocytes. 5.

Serum ferritin and transferrin saturation. 6.

Who Took Part

The registry lists 15 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Adult patients are 18 years old or above. Inpatients diagnosed as severe COVID - 19 disease according to WHO criteria. CT chest with extensive lung disease (ground-glass and consolidative pulmonary opacities). Respiratory rate equal or more than 30 per minute.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: patients with pregnancy and lactation; renal failure and heart failure; contraindication for plasma or blood transfusion.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-05-20 with completion listed for 2020-07-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example change in organs function with PFS and OS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 15 people.

Its size is small, so on its own it can only give an early look.

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.