A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) Versus Placebo in Asymptomatic Ambulatory Outpatients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 465
- 试验地点
- 12
- 主要终点
- Percentage of Asymptomatic Participants Who Remained Asymptomatic, i.e., Who Did Not Develop Symptomatic COVID-19 Through Day 14
研究概览
简要总结
The purpose of the study is to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (2 doses) versus placebo with regard to the percentage of asymptomatic participants who remain asymptomatic, i.e., who do not develop symptomatic coronavirus disease 2019 (COVID-19) through Day 14 as per the protocol defined criteria.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by qualitative PCR (reverse transcriptase (RT)-PCR), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for COVID-19 (inclusive of SARS-CoV-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment.
- •Asymptomatic with no constitutional COVID-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at Screening.
- •Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at Screening.
- •National Early Warning Score (NEWS) ≤ 2 points at Screening.
- •Participant provides informed consent (ICF) prior to initiation of any study procedures.
排除标准
- •Participants who are admitted to hospital or for whom hospital admission is being planned at the time of Screening.
- •Participants requiring any form of oxygen supplementation at Screening.
- •Concurrent or planned treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including remdesivir.
- •Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against SARS-CoV-2
- •Have participated in a previous SARS-CoV-2 vaccine study OR outside of a study have received any SARS-CoV-2 vaccine of any kind.
- •Have a history of convalescent COVID-19 plasma treatment at Screening.
- •Fever (temperature ≥38.0° C [≥100.4° F]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at Screening.
- •Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk for study treatment.
- •The participant has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
- •Decompensated congestive heart failure or renal failure with fluid overload. This includes currently uncontrolled congestive heart failure New York Heart Association Class III or IV stage heart failure.
- •Participants for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
- •Currently participating in another interventional clinical trial with investigational medical product or device.
- •Participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (IVIG) therapy in the past.
- •Participant has medical condition (other than COVID-19) that is projected to limit lifespan to ≤ 1 year.
- •Participant has history of drug or alcohol abuse within the past 12 months.
- •Participant is unwilling to commit to follow-up visits.
- •Women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.
- •True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception).
- •Note: Women who are >55 years and with the absence of menses in the last 12 months are considered to be not of childbearing potential. Female participants of childbearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hCG)-based assay at Screening/Baseline Visit.
研究组 & 干预措施
C19-IG 20% 1 g
Participants will receive 1 gram (g) of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 milliliters (mL) C19-IG 20% plus one syringe of 5 mL sterile 0.9% sodium chloride (NaCl) on Day 1.
干预措施: C19-IG 20% (Biological)
C19-IG 20% 1 g
Participants will receive 1 gram (g) of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 milliliters (mL) C19-IG 20% plus one syringe of 5 mL sterile 0.9% sodium chloride (NaCl) on Day 1.
干预措施: 0.9% Sodium chloride (Drug)
C19-IG 20% 2 g
Participants will receive 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1.
干预措施: C19-IG 20% (Biological)
Placebo
Participants will receive C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% NaCl injection on Day 1.
干预措施: 0.9% Sodium chloride (Drug)
结局指标
主要结局
Percentage of Asymptomatic Participants Who Remained Asymptomatic, i.e., Who Did Not Develop Symptomatic COVID-19 Through Day 14
时间窗: Up to Day 14
Participants were described as symptomatic if they a. experienced at least two of the following systemic symptoms: fever (≥38 ºC), chills, myalgia, headache, sore throat, cough, fatigue that interferes with activities of daily living, new olfactory/taste disorder(s), and vomiting/diarrhea, b. experienced at least one of the following respiratory signs/symptoms: new or worsening shortness of breath or difficulty breathing; c. experienced a peripheral oxygen saturation by pulse oximetry (SpO2) \<94% on room air; or d. had radiographical evidence of pneumonia. The percentage of participants who meet the primary endpoint within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% confidence interval (CI).
次要结局
- Duration of Any Oxygen Use Through Day 29(Up to Day 29)
- Absolute Value Score on a 7-point Ordinal Scale(Baseline, Day 7, 14, and 29)
- Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL)(Baseline to Day 7 and Day 14)
- Percentage of Participants Who Remained in an Outpatient Setting and Maintained SpO2 ≥94% on Room Air on Day 3, Day 7, and Day 14(Day 3, Day 7, and Day 14)
- Percentage of Participants Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) Test at Multiple Timepoints Through Day 14 and Through Day 29(Day 3, Day 7, Day 14, and Day 29)
- Time to Negative SARS-CoV-2 PCR From Baseline Through Day 29(Baseline to Day 29)
- Percentage of Participants Who Required Oxygen (O2) Supplementation on or Before Day 29(Up to Day 29)
- Change From Baseline in National Early Warning Score (NEWS)(Baseline to Day 7, Day 14, and Day 29)
- Percentage of Participants Who Required At Least One COVID-19 Related Medically Attended Visit (MAV) for Management/Treatment of COVID-19 Which May Have Occurred in Any Setting Through Day 29(Up to Day 29)
- Percentage of Participants Who Required Hospital Admission for Medical Care (Non-Quarantine Purposes) Through Day 29(Up to Day 29)
- Duration of Hospital Stay Through Day 29(Up to Day 29)
- Mean Change From Baseline in the 7-point Ordinal Scale(Baseline to Day 7, Day 14, and Day 29)
- Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale(Days 1, 7, 14, and 29)
- Percentage of Participants Who Required Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care Through Day 29(Up to Day 29)
- Duration of ICU Stay Through Day 29(Up to Day 29)
- Percentage of Participants Requiring Invasive Mechanical Ventilation Through Day 29(Up to Day 29)
- Duration of Invasive Mechanical Ventilation Through Day 29(Up to Day 29)
- All-Cause Mortality Through Day 29(Up to Day 29)
- Percentage of Participants With Critical COVID-19 Illness(Up to Day 29)
- Length of Time to Clinical Progression to Critical COVID-19 Illness Through Day 29(Up to Day 29)
- Time to COVID-19 Symptoms Through Day 14(Up to Day 14)