COVID-19 Clinical Trial
Official title:
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
Verified date | March 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
Status | Completed |
Enrollment | 593 |
Est. completion date | May 21, 2021 |
Est. primary completion date | May 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - SARS-CoV-2 infection documented by polymerase chain reaction (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 (admission for public health or quarantine only is not included) - 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: 1. Invasive ventilation 2. Non-invasive ventilation 3. Extracorporeal membrane oxygenation 4. Mechanical circulatory support 5. 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 Association Class III or IV stage heart failure) - Any of the following thrombotic or procoagulant disorders: 1. Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization 2. 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 subject or that could prevent, limit, or confound the protocol-specified assessments |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus Universitetshospital, Skejby | Aarhus | |
Denmark | Bispebjerg Hospital | Copenhagen | |
Denmark | CHIP, Department of Infectious Diseases, Section 2100 | Copenhagen | |
Denmark | Herlev-Gentofte Hospital | Hellerup | |
Denmark | Nordsjællands Hospital, Hillerød | Hillerød | |
Denmark | Hvidovre University Hospital, Department of Infectious Diseases | Hvidovre | |
Denmark | Kolding Sygehus | Kolding | |
Denmark | Odense University Hospital | Odense | |
Greece | Democritus University of Thrace | Alexandroupoli | Thrace |
Greece | 1st Respiratory Medicine Dept, Athens University Medical School | Athens | |
Greece | 3rd Dept of Medicine, Medical School, NKUA | Athens | |
Greece | Attikon University General Hospital | Athens | |
Greece | Dept. of Critical Care & Pulmonary Medicine, Evangelismos General Hospital | Athens | |
Japan | NCGM | Tokyo | |
Japan | Fujita Health University Hospital | Toyoake | |
Nigeria | Institute of Human Virology-Nigeria (IHVN) | Abuja | |
Spain | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
Spain | Hospital Clínic de Barcelona | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | Catalonia |
United Kingdom | Royal Free Hospital | London | |
United States | Hendrick Medical Center | Abilene | Texas |
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
United States | Penrose Hospital | Colorado Springs | Colorado |
United States | St. Francis Health Services | Colorado Springs | Colorado |
United States | University of Missouri | Columbia | Missouri |
United States | Ohio Health Research Institute | Columbus | Ohio |
United States | CHRISTUS Spohn Shoreline Hospital | Corpus Christi | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | St. Anthony Hospital | Lakewood | Colorado |
United States | Hennepin Healthcare Research Institute/HCMC | Minneapolis | Minnesota |
United States | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina |
United States | CJW Chippenham Medical Center | Richmond | Virginia |
United States | Henrico Doctors' Hospital (HCA) | Richmond | Virginia |
United States | Redmond Regional Medical Center | Rome | Georgia |
United States | Cox Medical Centers | Springfield | Missouri |
United States | Washington VA Medical Center | Washington | District of Columbia |
United States | Saint Anthony North Health Campus | Westminster | Colorado |
United States | University of Massachusetts | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) |
United States, Denmark, Greece, Japan, Nigeria, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ordinal Outcome Scale - Day 7 | The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories:
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 Outcome is reported as the percent of participants in each of 7 categories. Primary 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. Minimum value = 1, Maximum value = 7 Higher scores mean a worse outcome |
7 days | |
Primary | Primary Safety Outcome - Death, SAE or Grade 3 or 4 Events Through Day 7 | Number of participants with death, SAE or Grade 3 or 4 event through Day 7 | Through Day 7 | |
Secondary | N Reaching 3 Least Favorable Categories | N Reaching 3 least favorable categories of ordinal outcome (Categories 5, 6, 7: life-threatening end organ dysfunction, end organ failure, or death) | All of follow-up (through Day 28) | |
Secondary | N Reaching 2 Most Favorable Categories | N Reaching 2 most favorable categories of ordinal outcome (Categories 1 and 2: not requiring oxygen with or without limiting symptoms due to COVID-19) | All of follow-up (through Day 28) | |
Secondary | N Discharged or in Most Favorable Category | N discharged from hospital or reaching most favorable ordinal category (category 1: not requiring oxygen and no limiting symptoms due to COVID-19) | All of follow-up (through Day 28) |
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