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临床试验/NCT05046652
NCT05046652已完成不适用

Effectiveness of Convalescent Plasma Therapy in 8 Non-Intubated COVID-19 Patients in Indonesia: A Case Series

Maranatha Christian University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Patients with two doses of CP tended to have faster recovery than those with one dose of CP.

研究概览

简要总结

This is the first Case Studies article highlight factors determine the effectiveness of Convalescent Plasma Therapy (CPT) in Indonesia, accompanied by supporting data and images before and after the patients received the therapy. This Case Studies gives a huge contribution as CPT still on going as multicentre study and apply massively as emergency approved treatment in Indonesia.

详细描述

Eight non-intubated Covid-19 patients confirmed by real-time viral RNA PCR tests were included. Four patients had been administered two doses of 200 mL convalescent plasma (CP) and another four patients had been administered one dose of CP with an antibody titer of 1:320. This study has three goals included to detect the improvement of patient clinical and laboratory conditions, safety of CPT, and conversion from positive to negative results after CPT administration. Convalescent plasma applied within two weeks (13 days) from onset of illness and within a week (6.5 days) from the first day of hospital admission for all patients. Improvements in clinical symptoms, laboratory parameters, thorax photo, negative conversion of PCR, and decreased oxygen supplementation occurred within a week after CPT. Patients with two doses of CP tended to have faster recovery than those with one dose of CP. No severe adverse effects were observed in any patient. This is the first case series in Indonesia showing CPT is safe and well tolerated, and early CPT before the patient is intubated could potentially prevent disease progression, increase the recovery rate, and shorten the inpatient days.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • COVID-19 patients
  • Severe stage
  • Positive PCR swab

排除标准

  • Non-COVID-19 patients
  • No Symptoms COVID-19 patients
  • Mild COVID-19 patients

结局指标

主要结局

Patients with two doses of CP tended to have faster recovery than those with one dose of CP.

时间窗: 1 April 2020 - 31 December 2020

The median time from onset of illness to CPT was 13 days (within two weeks), and from the first day of hospital admission to CPT was 6.5 days (within a week). There were improvements in clinical symptoms, laboratory parameters, thorax photo, negative conversion of PCR, and decreased oxygen supplementation within a week after CPT. No severe adverse effects were observed in any patient.

次要结局

  • Patients with two doses of CP tended to have faster PCR negative conversion time than those with one dose of CP(1 April 2020 - 31 December 2020)

研究者

发起方
Maranatha Christian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresia Monica Rahardjo

Director of Unggul Karsa Medika Hospital

Maranatha Christian University

研究点 (1)

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