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Mortality reduction in 46 severe Covid-19 patients treated with hyperimmune
plasma A proof of concept single arm multicenter trial
#MMPMID33256382
Perotti C
; Baldanti F
; Bruno R
; Del Fante C
; Seminari E
; Casari S
; Percivalle E
; Glingani C
; Musella V
; Belliato M
; Garuti M
; Meloni F
; Frigato M
; Di Sabatino A
; Klersy C
; De Donno G
; Franchini M
; Covid-Plasma Task Force
Haematologica
2020[Dec]; 105
(12
): 2834-2840
PMID33256382
show ga
Hyperimmune plasma from Covid-19 convalescent is a potential treatment for severe
Covid-19. We conducted a multicenter one arm proof of concept interventional
study. Patients with Covid-19 disease with moderate-to-severe Acute Respiratory
Distress Syndrome, elevated C-reactive Protein and need for mechanical
ventilation and/or CPAP were enrolled. One to three 250-300 ml unit of
hyperimmune plasma (neutralizing antibodies titer ?1:160) were administered.
Primary outcome was 7-days hospital mortality. Secondary outcomes were PaO2/FiO2,
laboratory and radiologic changes, as well as weaning from mechanical ventilation
and safety. The study observed 46 patients from March, 25 to April, 21 2020.
Patients were aged 63, 61% male, of them, 30 were on CPAP and 7 intubated.
PaO2/FiO2 was 128 (SD 47). Bilateral infiltrates on chest X-ray was present in 36
patients (84%). Symptoms and ARDS duration were 14 (SD 7) and 6 days (SD 3).
Three patients (6.5%) died within 7 days as compared to an expected 15% from the
National Statistics and 30% from a small concurrent cohort of 23 patients. The
upper one-sided 90%CI was 13.9%, allowing to reject the null hypothesis of a 15%
mortality. PaO2/FiO2 increased by 112 units (95%CI 82 to142) in survivors, the
chest radiogram severity decreased in 23% (95%CI 5% to 42%); CRP, Ferritin and
LDH decreased by 60, 36 and 20% respectively. Weaning from CPAP was obtained in
26/30 patients and 3/7 were extubated. Five serious adverse events occurred in 4
patients (2 likely, 2 possible treatment related). In conclusion, Hyperimmune
plasma in Covid-19 shows promising benefits, to be confirmed in a randomized
controlled trial. This proof of concept study could open to future developments
including hyperimmune plasma banking, development of standardized pharmaceutical
products and monoclonal antibodies.
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