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)

Office of Sponsored Projects, Regents of the University of Minnesota0 个研究点目标入组 500 人开始时间: 2020年9月17日最近更新: 2020年10月6日

试验速览

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•In order to be eligible to participate in this study, a participant must meet all of the following criteria:
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•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
•9. Prior participation in a COVID-19 treatment trial within 6 months of enrolment

发起方

Office of Sponsored Projects, Regents of the University of Minnesota