High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial

What Was Tested

Researchers studied Methylene blue (non-peptide stack partner) in this randomized controlled trial publication.

Convalescent plasma has been proposed as an early treatment to interrupt the progression of early COVID-19 to severe disease, but there is little definitive evidence.

Who Took Part

PubMed indexes the participants as adults and middle-aged adults.

Adult outpatients aged 50 years or older with the onset of mild COVID-19 symptoms 7 days or less before randomisation were eligible for enrolment.

Randomisation was done with the use of a central web-based system with concealment of the trial group assignment and no stratification.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter 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.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Methylene blue (non-peptide stack partner) group a baseline to be compared against.

More than one site took part, so the participants came from several places.

A time span of 28 days appears in the methods.

The researchers did a multicentre, double-blind, randomised, placebo-controlled trial in four health-care centres in Catalonia, Spain.

To preserve masking, the researchers used opaque tubular bags that covered the investigational product and the infusion catheter.

The coprimary endpoints were the incidence of hospitalisation within 28 days from baseline and the mean change in viral load (in log10 copies per mL) in nasopharyngeal swabs from baseline to day 7.

This study is registered with ClinicalTrials.gov, NCT04621123.

What Was Measured

PubMed files the paper under topics including COVID-19, COVID-19 Vaccines, Immunization, Passive, Methylene Blue, Outpatients, SARS-CoV-2 and COVID-19 Serotherapy.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Methylene blue (non-peptide stack partner) over 28 days.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2022 (The Lancet. Respiratory medicine), a journal based in England.

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