Phase
Condition
Covid-19
Treatment
IVIG Placebo + Coordinated Care
IVIG + Coordinated Care
IVIG + Usual Care
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥ 18 years of age at the time of enrollment
Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by thePan American Health Organization12ɸ ɸ Enrollment of participants with suspected orprobable SARS-CoV-2 infection will only be allowed if they occurred before May 1, 2021 and be limited to no more than 10% of the total sample size per Study DrugAppendix. Refer to the Manual of Procedures (MOP) for details. Suspected case of SARS-CoV-2 infection - Three options, A through C: A. Meets the clinical OR epidemiological criteria.
Clinical criteria: Acute onset of fever AND cough (influenza-like illness) ORAcute onset of ANY THREE OR MORE of the following signs or symptoms: fever,cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza,dyspnea, nausea, diarrhea, anorexia.
Epidemiological criteria: Contact of a probable or confirmed case or linked toa COVID-19 cluster; or B. Presents with acute respiratory infection withhistory of fever or measured fever of ≥ 38°C; and cough; with onset within thelast 10 days; and who requires hospitalization); or C. Presents with noclinical signs or symptoms, NOR meeting epidemiologic criteria with a positiveprofessional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test. Probable case of SARS-CoV-2 infection, defined as meets clinical criteria above ANDis a contact of a probable or confirmed case or is linked to a COVID-19 cluster. Confirmed case of SARS-CoV-2 infection - Two options, A through B: A. A person with a positive nucleic acid amplification test, regardless of clinicalcriteria OR epidemiological criteria; or B. Meeting clinical criteria AND/ORepidemiological criteria (See suspect case A). With a positive professional use orself-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
Moderate, self-identified autonomic symptoms (defined as COMPASS-31 >25) following aSARS-CoV-2 infection that has persisted for at least 12 weeks and is still presentat the time of consent
OHQ/OIQ, question 1 score >2
Exclusion
Exclusion Criteria:
Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
Known renal failure (eGFR <20ml/1.73 m²)
Known atrial fibrillation or significant cardiac arrhythmia
Known cardiovascular conditions such as heart failure (Class 3-4), severe valvulardisease, symptomatic ischemic coronary artery disease, revascularization for PAD/CADwithin the past 6 months
Clinically significant atherosclerotic disease, defined as history of stroke ormyocardial infarction or revascularization 6 months prior to enrollment and/orcurrent symptomatic angina
Existing uncontrolled hypertension
History of significant hypercoagulability disorders
Active or recent thrombosis
Study Design
Study Description
Connect with a study center
East Alabama Medical Center - Appendix A & B
Opelika, Alabama 36801
United StatesActive - Recruiting
East Alabama Medical Center - Appendix B Only
Opelika, Alabama 36801
United StatesActive - Recruiting
Center for Complex Neurology - Appendix A & B
Phoenix, Arizona 85006
United StatesActive - Recruiting
University of Arkansas for Medical Sciences - Appendix A & B
Little Rock, Arkansas 72205
United StatesActive - Recruiting
University of California San Diego - Appendix A & B
La Jolla, California 92307
United StatesActive - Recruiting
University of California San Diego - Appendix B Only
La Jolla, California 92307
United StatesActive - Recruiting
Cedars Sinai Medical Center - Appendix A & B
Los Angeles, California 90048
United StatesActive - Recruiting
Stanford University - Appendix A & B
Stanford, California 94305
United StatesActive - Recruiting
Stanford University - Appendix B Only
Stanford, California 94305
United StatesActive - Recruiting
University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B
Aurora, Colorado 80045
United StatesActive - Recruiting
MedStar National Rehabilitation Hospital - Appendix B only
Washington, District of Columbia 20010
United StatesActive - Recruiting
University of Florida Health - Appendix A & B
Gainesville, Florida 32610
United StatesActive - Recruiting
Lakeland Regional Medical Center - Appendix A & B
Lakeland, Florida 33805
United StatesActive - Recruiting
Innovation Clinical Trials Inc.- Appendix A & B
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B
Atlanta, Georgia 30303
United StatesActive - Recruiting
Morehouse School of Medicine - Appendix A & B
Atlanta, Georgia 30310
United StatesActive - Recruiting
Queens Medical Center - Appendix A & B
Honolulu, Hawaii 96813
United StatesActive - Recruiting
Queens Medical Center - Appendix B Only
Honolulu, Hawaii 96813
United StatesActive - Recruiting
Rush University Medical Center - Appendix A & B
Chicago, Illinois 60612
United StatesActive - Recruiting
Rush University Medical Center - Appendix B Only
Chicago, Illinois 60612
United StatesActive - Recruiting
University of Illinois at Chicago - Appendix A & B
Chicago, Illinois 60612
United StatesActive - Recruiting
NorthShore University HealthSystem - Evanston Hospital
Evanston, Illinois 60201
United StatesSite Not Available
NorthShore University HealthSystem - Evanston Hospital - Appendix B Only
Evanston, Illinois 60201
United StatesActive - Recruiting
University of Iowa - Appendix A & B
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Kansas Medical Center CTSU Fairway - Appendix A & B
Fairway, Kansas 66205
United StatesActive - Recruiting
University of Kentucky Medical Center - Appendix A & B
Lexington, Kentucky 40536
United StatesActive - Recruiting
University Medical Center New Orleans - Appendix A & B
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Johns Hopkins Hospital - Appendix A & B
Baltimore, Maryland 21287
United StatesActive - Recruiting
Johns Hopkins Hospital - Appendix A Only
Baltimore, Maryland 21287
United StatesActive - Recruiting
Brigham and Women's Hospital - Appendix A & B
Boston, Massachusetts 02115
United StatesActive - Recruiting
Brigham and Women's Hospital - Appendix A Only
Boston, Massachusetts 02115
United StatesActive - Recruiting
Henry Ford Hospital - Appendix A & B
Detroit, Michigan 48202
United StatesActive - Recruiting
Mayo Clinic - Appendix A & B
Rochester, Minnesota 55905
United StatesActive - Recruiting
University of Mississippi Medical Center - Appendix A & B
Jackson, Mississippi 39216
United StatesActive - Recruiting
Washington University School of Medicine - Appendix A & B
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School of Medicine - Appendix B Only
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Montefiore Medical Center - Moses Campus - Appendix A & B
Bronx, New York 10467
United StatesActive - Recruiting
Montefiore Medical Center - Moses Campus - Appendix B
Bronx, New York 10467
United StatesActive - Recruiting
University at Buffalo - Appendix A & B
Buffalo, New York 14203
United StatesActive - Recruiting
St. Lawrence Health Medical Campus - Appendix A & B
Canton, New York 13617
United StatesActive - Recruiting
Columbia University Irving Medical Center - Appendix A & B
New York, New York 10032
United StatesActive - Recruiting
Stony Brook University Hospital - Appendix A & B
Stony Brook, New York 11794
United StatesActive - Recruiting
Duke University Hospital - Appendix A & B
Durham, North Carolina 27710
United StatesActive - Recruiting
East Carolina University - Appendix A & B
Greenville, North Carolina 27834
United StatesSite Not Available
East Carolina University - Appendix B
Greenville, North Carolina 27834
United StatesActive - Recruiting
East Carolina University - Appendix B Only
Greenville, North Carolina 27834
United StatesActive - Recruiting
Cleveland Clinic - Appendix A & B
Cleveland, Ohio 44195
United StatesActive - Recruiting
University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Oregon Health and Science University - Appendix A & B
Portland, Oregon 97239
United StatesActive - Recruiting
Kent Hospital - Appendix A & B
Pawtucket, Rhode Island 02860
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
National Neuromuscular Research Institute - Appendix A & B
Austin, Texas 78759
United StatesActive - Recruiting
National Neuromuscular Research Institute - Appendix B Only
Austin, Texas 78759
United StatesSite Not Available
Southwest Family Medicine Associates - Appendix A & B
Dallas, Texas 75235
United StatesActive - Recruiting
University of Texas Health Science Center at Houston
Houston, Texas 78701
United StatesActive - Recruiting
University of Texas Health Science Center at San Antonio - Appendix A & B
San Antonio, Texas 78229
United StatesActive - Recruiting
Bateman Horne Center - Appendix B Only
Salt Lake City, Utah 84102
United StatesActive - Recruiting
Vermont Lung Center, University of Vermont - Appendix A & B
Burlington, Vermont 05405
United StatesActive - Recruiting
Vermont Lung Center, University of Vermont - Appendix B Only
Burlington, Vermont 05405
United StatesActive - Recruiting
University of Virginia Health System, University Hospital - Appendix A & B
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Sentara Norfolk General Hospital - Appendix A & B
Norfolk, Virginia 23507
United StatesActive - Recruiting
Sentara Norfolk General Hospital - Appendix A and B
Norfolk, Virginia 23507
United StatesSite Not Available
Evergreen Hospital Medical Center - Appendix A & B
Kirkland, Washington 98034
United StatesActive - Recruiting
Providence Medical Research Center - Appendix A & B
Spokane, Washington 99204
United StatesActive - Recruiting
Marshall Health - University Physicians and Surgeons - Appendix A & B
Huntington, West Virginia 25701
United StatesActive - Recruiting
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