Infusion of Convalescent Plasma for the Treatment of Patients Infected With Severe Acute Respiratory Syndrome-Coronavirus-2 (COVID-19): A Double-blinded, Placebo-controlled, Proof-of-concept Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Oxygen supplementation
研究概览
简要总结
Patients who are ill with COVID-19 may benefit from receiving convalescent plasma infusions containing antibodies from donors who have recovered from the disease and are proven to no longer be infected. Given the current public health emergency due to COVID-19, the FDA has recently fast-tracked the use of convalescent plasma. The purpose for this study is to assess if convalescent plasma collected from donors previously infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, can provide clinical benefit to those acutely ill with the virus and to evaluate if such treatment is safe.
There will be two arms in the interventional study, where subjects will either be treated with convalescent plasma or fresh frozen plasma in a randomized and blinded manner. As an additional comparison, the clinical course of subjects enrolled during the period of the study who do not receive an alternative treatment for COVID-19 will be assessed.
详细描述
Study Design and Procedures - Comparison group (no-treatment control)
- Subjects will be identified by reviewing a REDCap database containing the list of all patients at the University of Illinois at Chicago Hospital (UIC) who were tested for COVID-19. Using these data, the investigators will identify those subjects who are >40 years old, were admitted to the hospital during the period of the study, otherwise met all of the inclusion and exclusion criteria for the infusion arm of the study but were not enrolled and did not receive any medications for treatment of COVID-19 (were treated with only supportive care).
- Clinical data from the hospital admissions of these subjects will be entered into a REDCap database. The same clinical information captured for subjects who underwent transfusion (vital signs, oxygen status, etc.) will be entered into this database.
Study Design and Procedures - Intervention arms Screening Visit
- Patients admitted to UIC Hospital and meeting the inclusion criteria will be enrolled after documentation of informed consent.
- Enrolled subjects will answer a symptom screen, undergo a physical exam, and have clinical data extracted from their chart (including medical history, demographic information, vital signs and documentation of oxygen requirement).
- Women of childbearing age will be asked if there is a chance that they might be pregnant, if they are currently breastfeeding, and if they are planning to become pregnant.
- Blood will be drawn for a Complete Blood Count (CBC) and blood type and screen, and a sample of blood will be stored for research purposes.
- Nasopharyngeal and/or oropharyngeal swabs will be collected for Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) testing.
- A study investigator will ask the patient's primary team if they are planning on treating the patient with Remdesivir. If the patient qualifies for this medication, the study investigator will monitor the patient's chart and work with the patient's nurse to ensure that the first convalescent plasma infusion and first dose of Remdesivir are given within 24 hours of each other.
Study Design and Procedures - Transfusion Visits (Study days 0 and 1) Note - the first transfusion visit may be done on the same day as the screening visit if time permits, otherwise it will be done the following day. Items 1 and 2 will only be performed for the first transfusion visit if the visit occurs the day after the screening visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patient's nurse will be instructed to place the blood product in a paper bag so the label on the product is not visible to the study physicians or to the patient.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 40 years-old and over who are admitted to the University of Illinois Hospital (UIC) due to COVID-19
- •Positive oropharyngeal and/or nasopharyngeal swab test for SARS-CoV-2 by RT-PCR within the preceding 72 hours (performed by University of Illinois Hospital Laboratories or, if performed elsewhere, documented in the patient's UIC medical record)
- •Symptomatic infection with any of the following: fever, cough, dyspnea, or tachypnea > 22 breaths/min
- •Need for supplemental oxygen, between 1-5 liters/minute by nasal canula, to maintain O2 saturations >92%
- •Consents to comply with all protocol requirements
- •Agrees to storage of specimens for future testing
排除标准
- •Patients with known Immunoglobulin A deficiency (high risk of severe or fatal anaphylactic reactions)
- •Patients who are on a ventilator
- •Patients with past history of severe transfusion reaction including transfusion-related acute lung injury (TRALI) or anaphylaxis
- •Patients with a baseline requirement for supplemental oxygen due to chronic lung disease or with known history of either moderate-to-severe asthma or emphysema.
- •Female subjects who report that they are pregnant or breastfeeding
- •Receipt of pooled immunoglobulin in the past 30 days
- •Patients must be willing to not take any another alternative experimental treatment for COVID-19 from the time they undergo enrollment until the 28-day follow-up phone call
- •. Participants who are being treated with Remdesivir and have had their first dose of Remdesivir greater than 24 hours prior to the time they will receive their first dose of convalescent plasma
- •Patients with severe disease due to COVID-19, as manifested by a need for vasopressors, and/or diagnosis of Acute Respiratory Distress Syndrome
结局指标
主要结局
Oxygen supplementation
时间窗: 8 days
The primary endpoint will be clinical response at 8 days, defined as no need for oxygen supplementation for the previous 24 hours.
次要结局
- Number of participants intubated(28 days)
- 28-day and in-hospital mortality rate(28 days)
- Number of participants transferred to the Intensive Care Unit (ICU)(28 days)
- Length of hospital stay in days(28 days)
- Type of respiratory support(28 days)
- C-reactive Protein (CRP)(28 days)
- Lymphocyte count(28 days)
- Length or respiratory support required, in days(28 days)
- Lactate dehydrogenase (LDH)(28 days)
- Ferritin(28 days)
- D-Dimer(28 days)
- White Blood Cell (WBC) Count(28 days)
研究者
Jesica Herrick
Assistant Professor of Clinical Medicine
University of Illinois at Chicago