JPRN-jRCT2031200174已完成3 期
An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19 - Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)
Ohmagari Norio0 个研究点目标入组 593 人开始时间: 2020年10月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 593
研究概览
简要总结
When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. SARS-CoV-2 infection documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- •2. Symptomatic COVID-19 disease
- •3. Duration of symptoms attributable to COVID-19 =< 12 days
- •4. Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
- •5. Age => 18 years
- •6. Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
- •7. Provision of informed consent by participant or legally authorized representative
排除标准
- •1. Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
- •2. Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
- •3. Current or predicted imminent (within 24 hours) requirement for any of the following:
- •_Invasive ventilation
- •_Non-invasive ventilation
- •_Extracorporeal membrane oxygenation
- •_Mechanical circulatory support
- •_Continuous vasopressor therapy
- •4. History of allergy to IVIG or plasma products
- •5. History of selective IgA deficiency with documented presence of anti-IgA antibodies
- •6. Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient
- •_Includes New York Heart Association Class III or IV stage heart failure
- •7. Any of the following thrombotic or procoagulant disorders:
- •_Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization
- •_History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome
- •8. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
研究者
相似试验
已完成
3 期
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adultsovel Coronavirus Infectious Disease (COVID-19)JPRN-jRCT2031200092Ohmagari Norio969
已完成
3 期
Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)Covid19NCT06729593National Institute of Allergy and Infectious Diseases (NIAID)87
已完成
不适用
Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital LahoreCOVID-19NCT04871633King Edward Medical University66
已完成
2 期
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected PatientsChronic Hepatitis CHepatitis C (HCV)Hepatitis C Genotype 1NCT01464827AbbVie (prior sponsor, Abbott)580
尚未招募
不适用
A retrospective analysis to study the Effectiveness and Safety profile of Remdesivir therapy in patients who diagnosed with COVID-19CTRI/2021/01/030433Dr Vishal Shanbhag