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A Multi-Center, Open-Label, Randomized Controlled Trial to Evaluate the Efficacy of Convalescent Plasma Therapy for Coronavirus Disease 2019: A Trial Protocol (COVIPLA-RCT).
Tomita, Noriko; Saito, Sho; Terada-Hirashima, Junko; Mikami, Ayako; Uemura, Yukari; Kutsuna, Satoshi; Nomoto, Hidetoshi; Fujisawa, Kyoko; Nagashima, Maki; Terada, Mari; Ashida, Shinobu; Morioka, Shinichiro; Satake, Masahiro; Hangaishi, Akira; Togano, Tomiteru; Shiratori, Katsuyuki; Takamatsu, Yuki; Maeda, Kenji; Ohmagari, Norio; Sugiura, Wataru; Mitsuya, Hiroaki.
  • Tomita N; Center for Clinical Sciences, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Saito S; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Terada-Hirashima J; Center for Clinical Sciences, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Mikami A; Center for Clinical Sciences, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Uemura Y; Center for Clinical Sciences, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Kutsuna S; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Nomoto H; Department of Infection Control and Prevention, Osaka University Hospital, Osaka 565-0871, Japan.
  • Fujisawa K; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Nagashima M; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Terada M; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Ashida S; Center for Clinical Sciences, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Morioka S; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Satake M; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Hangaishi A; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Togano T; Central Blood Institute, Japanese Red Cross Society, Tokyo 135-8521, Japan.
  • Shiratori K; Department of Hematology, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Takamatsu Y; Department of Hematology, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Maeda K; Labotatory Testing Department, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
  • Ohmagari N; Department of Refractory Viral Infections, National Center for Global Health and Medicine Research Institute, Tokyo 162-8655, Japan.
  • Sugiura W; Department of Refractory Viral Infections, National Center for Global Health and Medicine Research Institute, Tokyo 162-8655, Japan.
  • Mitsuya H; Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
Life (Basel) ; 12(6)2022 Jun 08.
Article in English | MEDLINE | ID: covidwho-1884262
ABSTRACT

BACKGROUND:

Coronavirus disease 2019 is a global public health concern. As of December 2020, the therapeutic agents approved for coronavirus disease 2019 in Japan were limited to two drugs remdesivir, an antiviral drug, granted a Special Approval for Emergency on 7 May 2020, and dexamethasone, which has an anti-inflammatory effect. The aim of this study is to evaluate the efficacy of convalescent plasma collected from donors who recovered from coronavirus disease 2019.

METHODS:

This is an open-label, randomized controlled trial comprising two groups a convalescent plasma and a standard-of-care group. Plasma administered to patients with coronavirus disease 2019 randomized in the convalescent plasma group of this trial will be plasma that has been collected and stored in an associated study. Patients with a diagnosis of mild coronavirus disease 2019 will be included in this trial. The efficacy of convalescent plasma transfusion will be evaluated by comparing the convalescent plasma group to the standard-of-care group (without convalescent plasma transfusion) with respect to changes in the viral load and other measures. The primary endpoint will be time-weighted average changes in the SARS-CoV-2 virus load in nasopharyngeal swabs from day 0 to days 3 and 5. It is hypothesized that the intervention should result in a decrease in the viral load in the convalescent plasma group until day 5. This endpoint has been used as a change in viral load has and been used as an index of therapeutic effect in several previous studies.

DISCUSSION:

The proposed trial has the potential to prevent patients with mild COVID-19 from developing a more severe illness. Several RCTs of convalescent plasma therapy have already been conducted in countries outside of Japan, but no conclusion has been reached with respect to the efficacy of convalescent plasma therapy, which is likely in part because of the heterogeneity of the types of target patients, interventions, and endpoints among trials. Actually, previous clinical trials on plasma therapy have shown inconsistent efficacy and are sometimes ineffective in COVID-19 patients with severe disease, which is due to unmeasured neutralizing antibody titer in the COVID-19 convalescent plasma. To improve this issue, in this study, we measure neutralizing activity of convalescent plasma before administration and provide the plasma with high neutralizing activity to the subjects. It is hoped that this study will further evidence to support the role of convalescent plasma therapy in COVID-19.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: Life12060856

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: Life12060856