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ITAC Inpatient Treatment with Anti-Coronavirus Immunoglobulin

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
INSIGHT 0132020-002542-16NCT04546581

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

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

  • The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications

 

Secondary Outcomes

  • Secondary endpoints include time to the 3 least favorable categories, time to the 2 most favorable categories, and the pulmonary only and thrombotic only components of the primary ordinal outcome. Mortality, adverse events (AEs), including infusion reactions, and biological correlates of therapeutic activity are also assessed. Because there is no established endpoint for evaluating the clinical efficacy of treatments for COVID-19, other clinically relevant outcomes, including outcomes used in other COVID-19 treatment trials, will be recorded. Thus, the randomized groups (initially hIVIG + SOC versus placebo + SOC) can be compared for multiple outcomes, and results can be compared or combined with other trials.

 

Diagnosis

Covid-19 infection

Patient attributes

Stage

acute infection

Age

18-99

Inclusion criteria

  •  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
  •  Symptomatic COVID-19 disease
  •  Duration of symptoms attributable to COVID-19 ≤ 12 days
  •  Requiring inpatient hospital medical care for clinical manifestations of COVID-19  
  • Age ≥ 18 years
  •  Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
  • Provision of informed consent by participant or legally authorized representative
  • […]

 

Exclusion criteria

  •  Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
  • Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
  • 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

  •  History of allergy to IVIG or plasma products
  •  History of selective IgA deficiency with documented presence of anti-IgA antibodies
  •  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
  •  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

  • 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
  • […]

 

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Two-arm
  • Double-blind
  • Placebo-controlled

Intervention

Anti-Coronavirus Hyperimmune IVIG

 

Documents (password protected)

Responsibilities in overall trial

The University of Minnesota

    Sponsor representative

    Univ.-Prof. Dr. med. Gerd Fätkenheuer

    National Coordinating Investigator

    Univ.-Prof. Dr. med. Gerd Fätkenheuer

    Project management

    Klinik I für Innere Medizin

    Dr. Jakob J. Malin

    Monitoring

    acromion

      Data management

      CHIP Kopenhagen

      • Tel. +45 35 45 5757
      • Fax +45 35 45 5758

      Database development

      CHIP Kopenhagen

      • Tel. +45 35 45 5757
      • Fax +45 35 45 5758

      SAE management

      CHIP Kopenhagen

      • Tel. +45 35 45 5757
      • Fax +45 35 45 5758

      Statistics

      CHIP Kopenhagen

      • Tel. +45 35 45 5757
      • Fax +45 35 45 5758