One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients

Abstract

BACKGROUND. Results of many randomized trials on COVID-19 convalescent plasma (CCP) have been reported but information on long-term outcome after CCP treatment is limited. The objectives of this extended observation of the randomized CAPSID Trial are to assess long-term outcome and disease burden in patients initially treated with or without CCP. METHODS. Of 105 randomized patients, 50 participated in the extended observation. Quality of life (QoL) was assessed by questionnaires and a structured interview.CCP-donors (n=113) with asymptomatic to moderate COVID-19 were included as a reference group.RESULTS. The median follow-up of patients was 396 days, the estimated 1-year survival was 78.7% in the CCP and 60.2% in the control group (p=0.08). The subgroup treated with a higher cumulative amount of neutralizing antibodies showed a better 1-year survival compared to the control group (91.5% versus 60.2%; p=0.01). Medical events and QoL assessments showed a consistent trend for better results in the CCP group without reaching statistical significance. There was no difference in the increase of neutralizing antibodies after vaccination between CCP and the control group.CONCLUSION. The trial demonstrated a trend towards better outcome in the CCP group without reaching statistical significance. A pre-defined subgroup analysis showed a significant better outcome (long-term survival; time to discharge from ICU and time to hospital discharge) among those who received a higher amount of neutralizing antibodies compared to the control group. A substantial long-term disease burden remains after severe COVID-19.

Early Treatment, Inflammation and Post-COVID Conditions

“…A recent Veterans Affairs prepublication study demonstrated that treatment with nirmatrelvir during the acute phase reduces the risk of PCC [13]. CCP has been shown to reduce hospitalizations and prevent morbidity and mortality when provided early and at high-titer [32-39]. In this early treatment trial, CCP reduced COVID-19 related hospitalizations by 54% and demonstrated a trend towards lower odds of PCC overall, and even lower PCC odds among those treated with CCP within 5 days [27].…”

Immune Plasma for the Treatment of COVID-19: Lessons Learned so far

“…58 Among those who received a high or low cumulative amount of neutralizing units, the primary outcome occurred in 56.0% and in 32.1%, and in 30.8% in the control group (p ¼ 0.046 high titer vs. control). 58 In a retrospective analysis based on the U.S. National Registry of the Early Access Program (E.A.P. ), death within 30 days after plasma transfusion occurred in 22.3% of patients who had received high-titer CCP, 27.4% in the median-titer group, and 29.6% in the low-titer CCP group in a patient subgroup who had not received mechanical ventilation before transfusion (relative risk: 0.66, 95% CI: 0.48-0.91).…”

“…Censored patients are indicated by þ. High amount versus control: p ¼ 0.011 and high amount versus low amount: p ¼ 0.032 (log-rank test) 58.…”

Hyperimmunplasma: Gewinnung, Verarbeitung und therapeutische Anwendungen

“…So kann der Einsatz von Rekonvaleszentenblut oder RP laut Weltgesundheitsorganisation (WHO) eine Option für die Behandlung von Ebola darstellen [15]. Auch im Rahmen der Therapie von COVID-19 Patienten wurden RP mit unterschiedlichem Erfolg zur Behandlung eingesetzt [8,[16][17][18][19][20].…”

“…In der prädefinierten Subgruppe der Patienten, die mit einer höheren kumulativen Menge an neutralisierenden Antikörpern behandelt wurden, wurde jedoch eine signifikant verbesserte 1-Jahres-Überlebensrate im Vergleich zur Kontrollgruppe (91,5 % versus 60,2 %; p = 0,01) beobachtet. Zudem zeigten sich Vorteile hinsichtlich der Zeit bis zur Entlassung von der Intensivstation und aus dem Krankenhaus [16,17]. Eine kleine Studie mit einem SARS-CoV-2-Hyperimmunglobulin in hospitalisierten, schwer immunsupprimierten Patienten zeigte ebenfalls positive Effekte [71].…”