Compassionate Use of Remdesivir and Convalescent Plasma Therapy for Treatment of COVID-19 Infection in Nepal : A Prospective Observational Study (Amended Protocol)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Hospital and ICU length of stay
研究概览
简要总结
The objective of this compassionate use study is to provide access and evaluate the outcome of Remdesivir and COVID-19 convalescent plasma use in patients with COVID-19. This protocol provides a coordinated approach for distribution and guidance for safe and effective administration of Remdesivir and convalescent plasma with antibodies against SARS CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment and monitor them for the following specific objectives and outcomes:
SPECIFIC OBJECTIVES
- Provide access to convalescent plasma for hospitalized patients with severe COVID-19 infection (compassionate use, expanded access program)
- Monitor safety of the therapy with convalescent plasma containing antibodies against SAR CoV-2 and Remdesivir for hospitalized patients with severe COVID-19 infection
- Evaluate outcomes in patients who received convalescent COVID-19 plasma therapy alone, Remdesivir alone, and both agents.
Study Design: This study will be a prospective, observational clinical study with an intention-to-treat, cross-over design. Comparison groups will be patients who received convalescent plasma vs. those who received Remdesivir. In addition, cross-over to convalescent plasma arm will be allowed for patients who continued to get worse even after receiving Remdesivir for more than 48 hours.
详细描述
ENROLLMENT Patients will be recruited from all COVID-19 treating hospitals of Nepal which are participating in this clinical study. All hospitalized patients with moderate to severe COVID-19 infection will be screened for Remdesivir Treatment and those with severe to life threatening COVID-19 infection will be screened for Convalescent plasma therapy.
Donors Convalescent plasma donors will be recruited from the record of the hospitals from where they were discharged. The COVID hospitals will be asked to collect names of recovered patients who have voluntarily shown interest to donate plasma. When possible donated plasma will be stored in respective hospitals or blood bank.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hospital and ICU length of stay
时间窗: 12 Weeks
- number of days of hospital stay and ICU stay
Demographics of recipients
时间窗: 12 Weeks
- type of patients receiving plasma therapy : Age in Years, Sex: M/F,
Co-morbidity of recipient
时间窗: 12 Weeks
- recipient comorbidities: Smoking, Diabetes, Heart disease, Chronic lung disease, chronic liver disease, cancer, organ transplant, HIV infection, TB. HIV, HBV, HCV, Syphillis
Availability of convalescent plasma
时间窗: 12 Weeks
* percentage of donors who donated plasma versus those who were eligible for donation * percentage of patient who received plasma vs. requests received
Adverse events of convalescent COVID-19 plasma and Remdesivir Therapy
时间窗: 12 Weeks
* any expected and unexpected adverse events during or after treatment (upto 7 days) * any other complications related or unrelated to plasma transfusion and Remdesivir during hospital stay
Amount of Plasma
时间窗: 12 Weeks
- amount of plasma administered per patient
Donor status
时间窗: 12 Weeks
* donor health status: HIV, HBV, HCV, Syphillis * Donor status: duration after recovery from COVID-19, plasma antibody titer against SARS CoV-2
Disposition of patients including survival
时间窗: 12 Weeks
- condition at discharge: complete recovery, partial recovery with complications, death
次要结局
未报告次要终点
研究者
Dr. Pradip Gyanwali,MD
Chief-Executive
Nepal Health Research Council