Tråkigt med konvalescentplasma. Inga påvisbara positiva effekter i en stor studie i Indien.
Convalescent plasma in the management of moderate COVID-19 in India: An open-label
parallel-arm phase II multicentre randomized controlled trial (PLACID Trial)
https://www.medrxiv.org/content/10.1101/2020.09.03.20187252v1.full.pdf
/.../ However, it did not demonstrate anti-inflammatory
properties as we could not detect any difference in the levels of inflammatory markers such as
ferritin, CRP, D-Dimer or LDH between the two arms.
/.../However, the absence of a
controlled comparison weakens these findings as evidence of efficacy.26 Although underpowered,
we did not find any benefit of administration of plasma within 3 days of symptom onset.
/.../However, the goal of getting better clinical outcomes remained elusive for us. We did not find
evidence to support the immunomodulator functions of CP as we could not demonstrate
differences in the levels of inflammatory markers. This could potentially explain why CP had no
difference in primary outcome despite early SARS-CoV-2 viral RNA negativity.
Däremot dog tre av patienterna oklart dock om det var p.g.a. CP:
/.../Three deaths could possibly be related to CP transfusion, which is comparable to
the other larger reports of safety of CP use in COVID-19.12 Possible is defined here as a clinical
event which occurred within 6 hours of CP transfusion, but could also be explained by worsening
COVID-19.23
Och då detta beskriver läget i Indien så dyker de vanliga problemen upp med sådan här mirakelbehandling:
/.../Use of CP as a treatment modality for COVID-19 has received authorisation for off-label use in
India.29 This authorization has been paralleled by questionable practices such as calls for donors
on social media, and the sale of CP on the black market with exorbitant price tags in India.30
Rapporten bekräftar vad man har sett i 20 andra försök:
/.../A recent Cochrane review, including 20 studies [1 RCT, 3 controlled non-randomized study of
intervention (NRSI), 16 non-controlled NRSIs], concluded that there is uncertainty regarding
effectiveness of CP in improving mortality or clinical improvement in COVID-19 patients.15
Slutligen kommenterar Dr Gaetan Burgio rapporten från sitt Twitterkonto:
Dr Gaetan Burgio, MD, PhD.
@GaetanBurgio
This report on open label phase II randomized controlled trial for convalescent plasma + SOC versus SOC on 464 #COVID19 patients shows no benefit of the convalescent plasma treatment on mortality + progression to severe disease at day 28 post randomization
https://twitter.com/GaetanBurgio/status/1303666136223940608?s=20
Det här med SARS-CoV-2 och immunförsvar och hur det fungerar verkar förbli ett mysterium och man bör inte ta några spekulationer som fakta tills vidare.