COVID-19 (SARS-CoV-2) infection
Conditions
Interventions
Product Name: Anti-COVID-19 Hyperimmune Globulin (Human) - Grifols Therapeutics LLC
Pharmaceutical Form: Infusion
INN or Proposed INN: Anti-COVID-19 hyperimmune globulin(human)
Other descriptive name:
Sponsors
Regents of the University of Minnesota
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 SARSCoV- 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 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 Prior receipt of any SARS-CoV-2 monoclonal antibody treatments at any time • 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 randomizationHistory 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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:7. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1. No limiting symptoms due to COVID-19;Secondary Objective: 1. All-cause mortality through Day 28. 2. The primary ordinal outcome on Days 3, 5, 14 and 28. 3. Change in National Early Warning Score (NEWS) from baseline at Day 3. 4. Time to the 3 least favourable categories of the primary outcome measure 5. Time to the 2 most favourable categories of the primary outcome measure. 6. Hospitalization status (alive and discharged from the hospital to home or rehabilitation, versus dead or hospitalized) at Days 7, 14 and 28. 7. Time to discharge. 8. Days alive outside of a hospital through Day 28. ;Primary end point(s): 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. Categories are: 7. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1. No limiting symptoms due to COVID-19;Timepoint(s) of evaluation of this end point: Clinical status on Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. All-cause mortality through Day 28. 2. The primary ordinal outcome on Days 3, 5, 14 and 28. 3. Change in National Early Warning Score (NEWS) from baseline at Day 3. This is a scoring system validated in the UK, which is able to score how sick people are, and their risk of dying, based on things like their blood pressure, pulse rate and body temperature. 4. Time to the 3 least favourable categories of the primary outcome measure 5. Time to the 2 most favourable categories of the primary outcome measure 6. Hospitalization status (alive and discharged from the hospital to home or rehabilitation, versus dead or hospitalized) at Days 7, 14 and 28. 7. Time to discharge. 8. Days alive outside of a hospital through Day 28. 9. Pulmonary only components of the primary outcome measure at Days 3, 5, 7, 14 and 28 10. Thrombotic components of the primary outcome measure (stroke, myocardial infarction, venous and arterial thrombosis or embolism, plus disseminated intravascular coagulation) at Days 3, 5, 7, 14, and 28. 11. Outcomes assessed in other treatment trials of COVID-19 for hospitalized participants in order to facilitate cross trial comparisons and overviews, e.g., 6-, 7- and 8- category ordinal scales at days 7, 14 and 28; and binary outcomes defined by improvement or worsening based on the primary ordinal outcome and ordinal outcomes used in other trials.12. Clinical organ dysfunction defined by new onset of any one or more of the following conditions (or requirement for the following therapies) through Day 28: a. Respiratory: 1. Extracorporeal membrane oxygenation (ECMO) 2. Invasive ventilation 3. Non-invasive ventilation or high flow oxygen b. Cardiac and vascular: 1. Myocardial infarction 2. Myocarditis or pericarditis 3. NYHA Class III/IV congestive cardiac failure 4. Vasopressor therapy c. Renal: 1. Renal replacement therapy (dialysis) d. Hepatic: 1. Hepatic decompensation e. Neurological 1. Cerebrovascular event (stroke) 2. Encephalitis, | — |
Countries
Argentina, Belgium, Denmark, France, Germany, Greece, Israel, Japan, Mexico, Nigeria, Peru, Poland, Portugal, Spain, Thailand, United Kingdom, United States
Contacts
Public ContactUCL
MRC CTU
Outcome results
None listed