Health Condition 1: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Anti SARS CoV-2 Hyperimmune Intravenous Immunoglobulin: Anti-Coronavirus Hyperimmune IVIG contains polyvalent antibodies with neutralizing specificity for SARS-CoV-2. It has the potenti
Sponsors
University of Minnesota
National Institute of Allergy and Infectious Diseases NIAID National Institutes of Health NIH
Eligibility
Inclusion criteria
Inclusion 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 in patient 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
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 � 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 can be compared for multiple outcomes, and results can be compared or combined with other trials.Timepoint: The time points for the secondary outcome is day 28. Delayed outcome will be measured on day 90. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patientââ?¬â?¢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. Timepoint: On Days 1, 2, 3, 7, and 28 | — |
Countries
Denmark, Greece, India, Japan, Nigeria, Spain, United Kingdom, United States of America
Contacts
Public ContactDr Jerin Jose Cherian
Indian Council of Medical Research
Outcome results
None listed