Phase
Condition
Covid-19
Treatment
IVIG + Coordinated Care
IVIG + Usual Care
IVIG Placebo + 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 >20) 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
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
Inability to comply with the protocol
Any condition that the investigator believes makes it inappropriate to treat withstudy intervention, including severe debility.
History of POTS or significant dysautonomia before COVID-19 index infection
Enrolled in another clinical trial or another study intervention appendix in thisplatform protocol * Patients who are a part of observational studies (e.g. imaging)may be included in this trial. Participants may enroll in another interventionaltrial or re-enroll in this trial for a different study intervention appendix 30 daysafter end of study (Follow-up visit).
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 StatesSite Not Available
East Alabama Medical Center - Appendix B Only
Opelika 4081644, Alabama 4829764 36801
United StatesSite Not Available
Center for Complex Neurology - Appendix A & B
Phoenix, Arizona 85006
United StatesSite Not Available
Center for Complex Neurology - Appendix A & B
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
University of Arkansas for Medical Sciences - Appendix A & B
Little Rock, Arkansas 72205
United StatesSite Not Available
University of Arkansas for Medical Sciences - Appendix A & B
Little Rock 4119403, Arkansas 4099753 72205
United StatesSite Not Available
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 StatesSite Not Available
Cedars Sinai Medical Center - Appendix A & B
Los Angeles, California 90048
United StatesSite Not Available
Stanford University - Appendix A & B
Stanford, California 94305
United StatesActive - Recruiting
Stanford University - Appendix B Only
Stanford, California 94305
United StatesSite Not Available
University of California San Diego - Appendix B Only
La Jolla 5363943, California 5332921 92307
United StatesSite Not Available
Cedars Sinai Medical Center - Appendix A & B
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Stanford University - Appendix B Only
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
MedStar National Rehabilitation Hospital - Appendix B only
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar National Rehabilitation Hospital - Appendix B only
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
University of Florida Health - Appendix A & B
Gainesville, Florida 32610
United StatesSite Not Available
Lakeland Regional Medical Center - Appendix A & B
Lakeland, Florida 33805
United StatesSite Not Available
Innovation Clinical Trials Inc.- Appendix A & B
Palmetto Bay, Florida 33157
United StatesSite Not Available
University of Florida Health - Appendix A & B
Gainesville 4156404, Florida 4155751 32610
United StatesSite Not Available
Lakeland Regional Medical Center - Appendix A & B
Lakeland 4161438, Florida 4155751 33805
United StatesSite Not Available
Innovation Clinical Trials Inc.- Appendix A & B
Palmetto Bay 4167634, Florida 4155751 33157
United StatesSite Not Available
Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B
Atlanta, Georgia 30303
United StatesSite Not Available
Morehouse School of Medicine - Appendix A & B
Atlanta, Georgia 30310
United StatesSite Not Available
Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B
Atlanta 4180439, Georgia 4197000 30303
United StatesSite Not Available
Morehouse School of Medicine - Appendix A & B
Atlanta 4180439, Georgia 4197000 30310
United StatesSite Not Available
Queens Medical Center - Appendix A & B
Honolulu, Hawaii 96813
United StatesActive - Recruiting
Queens Medical Center - Appendix B Only
Honolulu, Hawaii 96813
United StatesSite Not Available
Queens Medical Center - Appendix B Only
Honolulu 5856195, Hawaii 5855797 96813
United StatesSite Not Available
Rush University Medical Center - Appendix A & B
Chicago, Illinois 60612
United StatesActive - Recruiting
Rush University Medical Center - Appendix B Only
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois at Chicago - Appendix A & B
Chicago, Illinois 60612
United StatesSite Not Available
NorthShore University HealthSystem - Evanston Hospital
Evanston, Illinois 60201
United StatesSite Not Available
NorthShore University HealthSystem - Evanston Hospital - Appendix B Only
Evanston, Illinois 60201
United StatesSite Not Available
Rush University Medical Center - Appendix B Only
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
University of Illinois at Chicago - Appendix A & B
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
NorthShore University HealthSystem - Evanston Hospital - Appendix B Only
Evanston 4891382, Illinois 4896861 60201
United StatesSite Not Available
University of Iowa - Appendix A & B
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa - Appendix A & B
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
University of Kansas Medical Center CTSU Fairway - Appendix A & B
Fairway, Kansas 66205
United StatesSite Not Available
University of Kansas Medical Center CTSU Fairway - Appendix A & B
Fairway 4271358, Kansas 4273857 66205
United StatesSite Not Available
University of Kentucky Medical Center - Appendix A & B
Lexington, Kentucky 40536
United StatesSite Not Available
University of Kentucky Medical Center - Appendix A & B
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
University Medical Center New Orleans - Appendix A & B
New Orleans, Louisiana 70112
United StatesSite Not Available
University Medical Center New Orleans - Appendix A & B
New Orleans 4335045, Louisiana 4331987 70112
United StatesSite Not Available
Johns Hopkins Hospital - Appendix A & B
Baltimore, Maryland 21287
United StatesActive - Recruiting
Johns Hopkins Hospital - Appendix A Only
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Hospital - Appendix A Only
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
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 StatesSite Not Available
Brigham and Women's Hospital - Appendix A Only
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Henry Ford Hospital - Appendix A & B
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Hospital - Appendix A & B
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Mayo Clinic - Appendix A & B
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic - Appendix A & B
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
University of Mississippi Medical Center - Appendix A & B
Jackson, Mississippi 39216
United StatesSite Not Available
University of Mississippi Medical Center - Appendix A & B
Jackson 4431410, Mississippi 4436296 39216
United StatesSite Not Available
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 StatesSite Not Available
Washington University School of Medicine - Appendix B Only
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
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 StatesSite Not Available
University at Buffalo - Appendix A & B
Buffalo, New York 14203
United StatesSite Not Available
St. Lawrence Health Medical Campus - Appendix A & B
Canton, New York 13617
United StatesSite Not Available
Columbia University Irving Medical Center - Appendix A & B
New York, New York 10032
United StatesSite Not Available
Stony Brook University Hospital - Appendix A & B
Stony Brook, New York 11794
United StatesSite Not Available
University at Buffalo - Appendix A & B
Buffalo 5110629, New York 5128638 14203
United StatesSite Not Available
St. Lawrence Health Medical Campus - Appendix A & B
Canton 5111484, New York 5128638 13617
United StatesSite Not Available
Columbia University Irving Medical Center - Appendix A & B
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Stony Brook University Hospital - Appendix A & B
Stony Brook 5139865, New York 5128638 11794
United StatesSite Not Available
Montefiore Medical Center - Moses Campus - Appendix B
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available
Duke University Hospital - Appendix A & B
Durham, North Carolina 27710
United StatesSite Not Available
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 StatesSite Not Available
Duke University Hospital - Appendix A & B
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
East Carolina University - Appendix B Only
Greenville 4469160, North Carolina 4482348 27834
United StatesSite Not Available
Cleveland Clinic - Appendix A & B
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic - Appendix A & B
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
Oregon Health and Science University - Appendix A & B
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health and Science University - Appendix A & B
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Kent Hospital - Appendix A & B
Pawtucket, Rhode Island 02860
United StatesSite Not Available
Kent Hospital - Appendix A & B
Pawtucket 5223869, Rhode Island 5224323 02860
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
National Neuromuscular Research Institute - Appendix A & B
Austin, Texas 78759
United StatesSite Not Available
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 StatesSite Not Available
University of Texas Health Science Center at Houston
Houston, Texas 78701
United StatesSite Not Available
University of Texas Health Science Center at San Antonio - Appendix A & B
San Antonio, Texas 78229
United StatesSite Not Available
National Neuromuscular Research Institute - Appendix A & B
Austin 4671654, Texas 4736286 78759
United StatesSite Not Available
Southwest Family Medicine Associates - Appendix A & B
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 78701
United StatesSite Not Available
University of Texas Health Science Center at San Antonio - Appendix A & B
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Bateman Horne Center - Appendix B Only
Salt Lake City, Utah 84102
United StatesSite Not Available
Bateman Horne Center - Appendix B Only
Salt Lake City 5780993, Utah 5549030 84102
United StatesSite Not Available
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 StatesSite Not Available
Vermont Lung Center, University of Vermont - Appendix B Only
Burlington 5234372, Vermont 5242283 05405
United StatesSite Not Available
University of Virginia Health System, University Hospital - Appendix A & B
Charlottesville, Virginia 22908
United StatesSite Not Available
Sentara Norfolk General Hospital - Appendix A & B
Norfolk, Virginia 23507
United StatesSite Not Available
Sentara Norfolk General Hospital - Appendix A and B
Norfolk, Virginia 23507
United StatesSite Not Available
University of Virginia Health System, University Hospital - Appendix A & B
Charlottesville 4752031, Virginia 6254928 22908
United StatesSite Not Available
Sentara Norfolk General Hospital - Appendix A & B
Norfolk 4776222, Virginia 6254928 23507
United StatesSite Not Available
Evergreen Hospital Medical Center - Appendix A & B
Kirkland, Washington 98034
United StatesSite Not Available
Providence Medical Research Center - Appendix A & B
Spokane, Washington 99204
United StatesSite Not Available
Evergreen Hospital Medical Center - Appendix A & B
Kirkland 5799841, Washington 5815135 98034
United StatesSite Not Available
Providence Medical Research Center - Appendix A & B
Spokane 5811696, Washington 5815135 99204
United StatesSite Not Available
Marshall Health - University Physicians and Surgeons - Appendix A & B
Huntington, West Virginia 25701
United StatesSite Not Available
Marshall Health - University Physicians and Surgeons - Appendix A & B
Huntington 4809537, West Virginia 4826850 25701
United StatesSite Not Available

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