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Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients-An Open-Label Phase II Clinical Trial.
Grubovic Rastvorceva, Rada M; Useini, Sedula; Stevanovic, Milena; Demiri, Ilir; Petkovic, Elena; Franchini, Massimo; Focosi, Daniele.
  • Grubovic Rastvorceva RM; Institute for Transfusion Medicine of RNM, 1000 Skopje, North Macedonia.
  • Useini S; Faculty of Medical Sciences, University Goce Delcev, 2000 Stip, North Macedonia.
  • Stevanovic M; Institute for Transfusion Medicine of RNM, 1000 Skopje, North Macedonia.
  • Demiri I; University Clinic for Infectious Diseases, 1000 Skopje, North Macedonia.
  • Petkovic E; University Clinic for Infectious Diseases, 1000 Skopje, North Macedonia.
  • Franchini M; Institute for Transfusion Medicine of RNM, 1000 Skopje, North Macedonia.
  • Focosi D; Division of Hematology, Caro Poma Hospital, 46100 Mantua, Italy.
Life (Basel) ; 12(10)2022 Oct 09.
Article in English | MEDLINE | ID: covidwho-2071605
ABSTRACT

BACKGROUND:

COVID-19 convalescent plasma (CCP) is an important antiviral option for selected patients with COVID-19. MATERIALS AND

METHODS:

In this open-label, phase 2, clinical trial conducted from 30 April 2020 till 10 May 2021 in the Republic of North Macedonia, we evaluated the efficacy and safety of CCP in hospitalized patients. Treatment was with a single unit of CCP having an anti-RBD IgG concentration higher than 5 AU/mL.

RESULTS:

There were 189 patients that completed the study, of which 65 (34.4%) had WHO 8-point clinical progression scale score of 3 (requiring hospital care but not oxygen support), 65 (34.4%) had a score of 4 (hospitalized and requiring supplemental oxygen by mask or nasal prongs), and 59 (31.2%) had a score of 5 (hospitalized and requiring supplemental oxygen by non-invasive ventilation or high-flow oxygen). Mean age was 57 years (range 22-94), 78.5% were males, 80.4% had elevated body mass index, and 70.9% had comorbidity. Following CCP transfusion, we observed clinical improvement with increase rates in oxygenation-free days of 32.3% and 58.5% at 24 h and seven days after CCP transfusion, a decline in WHO scores, and reduced progression to severe disease (only one patient was admitted to ICU after CCP transfusion). Mortality in the entire cohort was 11.6% (22/189). We recorded 0% mortality in WHO score 3 (0/65) and in patients that received CCP transfusion in the first seven days of disease, 4.6% mortality in WHO score 4 (3/65), and 30.5% mortality in WHO score 5 (18/59). Mortality correlated with WHO score (Chi-square 19.3, p < 0.001) and with stay in the ICU (Chi-square 55.526, p ≤ 0.001). No severe adverse events were reported.

CONCLUSIONS:

This study showed that early administration of CCP to patients with moderate disease was a safe and potentially effective treatment for hospitalized COVID-19 patients. The trial was registered at clinicaltrials.gov (NCT04397523).
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article