Other substances

IVIg

Healthy donor IgG immunoglobulins.

Phase of research

Potential treatment - clinical evidence

How it helps

Other treatment

Drug status

Used to treat other disease

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

IVIg is a mixed IgG preparation from the plasma of healthy human donors. It is prepared by Cohn fractionation. IVIg is used for treatment of various immunodeficiency, inflammatory, and autoimmune conditions (DrugBank).

IVIg-related entry on Wikipedia

Synonyms

Intravenous immunoglobulin gamma; Gamma globulin

Marketed as

ASCENIV; BIVIGAM; CUVITRU; FLEBOGAMMA; GAMASTAN; GAMMAGARD; GAMMAKED; GAMMAPLEX; GAMUNEX; HIZENTRA; HYQVIA; IGIVNEX; KIOVIG; OCTAGAM; PANZYGA; PRIVIGEN; XEMBIFY

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial Severe severity Protein factor Randomized controlled double-blind trial Mixed substance	Patients	2.86	Significantly decreased mortality in the treatment group when compared to the placebo group in severe SARS-CoV-2 patients. Sample size: 30 + 29 placebo. Dosage: 4 vials of 5 gm5 daily for 3 days.	Oct/21/2020
Intravenous Immunoglobulin Plus Methylprednisolone Mitigate Respiratory Morbidity in Coronavirus Disease 2019 Protein factor Small molecule Randomized controlled open trial Mixed substance	Hypoxic patients		In combination with methylprednisolone. Statistically significant improvement in oxygenation, lower rate of progression to mechanical ventilation, and reduced length of hospital stay in patients with alveolar-arterial gradient greater than 200 mm Hg (none of the subjects with lower gradient progressed to mechanical ventilation). No thrombotic events were recorded. Sample size: 16 + 17 control. Dosage: 0.5 g/kg daily for 3 days.	Nov/16/2020
Low-dose corticosteroid combined with immunoglobulin reverses deterioration in severe cases with COVID-19 Severe severity Small molecule Cohort study	Patients	13.49	When used as an adjunctive therapy together with low-dose corticosteroid treatment at the early stage of severe COVID-19, deterioration of clinical status (assessed by e. g. respiratory and oxygenation indicators, pulmonary imaging outcomes, markers of inflammation, and other biochemical indicators) was significantly reversed and mortality was decreased. Sample size: 239 (40 of which were severe). Dosage: 10-20 g daily for 7-14 days.	Nov/24/2020
Treatment of a case with COVID-19 administering intravenous immunoglobulin Severe severity Protein factor Case report Mixed substance	Patient	2.71	The treatent resulted in improvement of respiratory functions and regression of pulmonary infiltrates in a COVID-19 patient. Dosage: 0.5 g/kg on day 1; 0.5 g/kg on day 2.	Dec/24/2020
Infliximab and Intravenous Gammaglobulin in Hospitalized Severe COVID-19 Patients in Intensive Care Unit Severe severity Antibody Mixed substance Cohort study	Intubated severe COVID-19 patients	1.00	Lower mortality was observed in patients treated with infliximab combined with IVIg compared to control. The control group was statistically significantly older than the monotherapy group and numerically-only than the combined therapy group, however. Sample size: 23 + 11 (combined with infliximab) + 43 control. Dosage: 400 mg/kg a day in slow infusion for 3-5 days.	Feb/01/2021
High-Dose Intravenous Immunoglobulin in Severe Coronavirus Disease 2019: A Multicenter Retrospective Study in China Severe severity Critical severity Mixed substance Cohort study	Patients	5.09	In patients receiving high IVIg therapy, lower 28-day mortality compared to control was observed. The difference was more prominent in patients without comorbidities and those treated earlier in the course of the disease. Shortened time to IL-6, IL-10, and ferritin levels normalization was noted, as well. The therapy was well tolerated. Sample size: 26 + 89 control. Dosage: A cumulative dose of 2 g/kg over 2–5 days. Primary outcome: 28-day mortality.	Feb/19/2021
Combined intravenous immunoglobulin and baricitinib treatment for severe COVID-19 with rhabdomyolysis: A case report Severe severity Elderly Small molecule Case report Mixed substance	An elderly severe COVID-19 patient with rhabdomyolysis	3.01	Combined with baricitinib. Biochemical, radiological, and clinical improvement was observed in an elderly patient with severe COVID-19 and rhabdomyolysis.	Mar/24/2021
Hyperinflammation with COVID-19: The key to patient deterioration? IL-1 Protein factor Case report Antibody Mixed substance	A patient at risk of disease progression		Treatment using anakinra and IVIg administered during two days led to clinical improvement in a COVID-19 patient with pancytopenia and high levels of inflammatory markers. Sample size: 1.	May/24/2020
Multisystem inflammatory syndrome in adults: A rare sequela of SARS-CoV-2 infection IL-1 Severe severity Protein factor Small molecule Case report Antibody	A multisystem inflammatory syndrome patient	3.62	A patient diagnosed with multisystem inflammatory syndrome related to COVID-19 was successfully treated using high-dose methylprednisolone, anakinra, acetylsalicylic acid, and IVIg. Sample size: 1. Dosage: A single infusion of 1 mg/kg.	May/23/2021
Multisystem Inflammatory Syndrome in Children during the COVID-19 Pandemic: A Case Report on Managing the Hyperinflammation IL-1 Severe severity Protein factor Children Small molecule Case report Antibody	A multisystem inflammatory syndrome paediatric patient	1.44	A paediatric patient diagnosed with COVID-19-related multisystem inflammatory syndrome was successfully treated using methylprednisolone, anakinra, and IVIg. Sample size: 1. Dosage: Two doses of 2 g/kg.	Jan/30/2021
Extracorporeal Membrane Oxygenation for COVID-19-Associated Multisystem Inflammatory Syndrome in a 5-year-old RdRpol IL-1 Protein factor Children Small molecule Critical severity Case report Antibody Mixed substance	A paediatric patient on ECMO.	0.69	A paediatric patient on ECMO was treated with remdesivir, methylprednisolone, IVIg, and anakinra. Sample size: 1.	Dec/09/2020

AI-suggested references

Link	Publication date
COVID-19: Cytokine storm modulation/blockade with oral polyvalent immunoglobulins (PVIG, KMP01D): A potential and safe therapeutic agent (Primum nil nocere).	Mar/29/2022
Effects of adjunct treatment with intravenous immunoglobulins on the course of severe COVID-19: results from a retrospective cohort study.	Feb/14/2021
[Immune thrombocytopenia after BNT162b2 mRNA COVID-19 vaccination].	Aug/17/2021
Neutralizing and binding activities against SARS-CoV-1/2, MERS-CoV, and human coronaviruses 229E and OC43 by normal human intravenous immunoglobulin derived from healthy donors in Japan.	Oct/26/2020
Case Series of Successful Intravenous Immunoglobulin (IVIG) Treatment in 4 Pregnant Patients with Severe COVID-19-Induced Hypoxia.	May/14/2022
Mucous membrane pemphigoid and COVID-19 treated with high-dose intravenous immunoglobulins: a case report.	May/15/2020
Efficacy of Plasmapheresis and Immunoglobulin Replacement Therapy (IVIG) on Patients with COVID-19.	Jul/31/2020
Intravenous Immunoglobulins at the Crossroad of Autoimmunity and Viral Infections	May/24/2021
Pharmacological mechanism of immunomodulatory agents for the treatment of severe cases of COVID-19 infection	Jun/25/2020
COVID-19-associated meningoencephalitis treated with intravenous immunoglobulin.	Sep/06/2020
Efficacy of high-dose intravenous immunoglobulin in severe and critical COVID-19: A retrospective cohort study	Aug/28/2020
Case Report: Successful Response to Intravenous Immunoglobulin and Steroid Pulses in a Renal Transplant Recipient With Severe Covid-19 Disease and Associated Acute Allograft Failure	May/11/2021
Reactivation of SARS-CoV-2 after Rituximab in a Patient with Multiple Sclerosis.	Mar/25/2021
A single center experience of intravenous immunoglobulin treatment in Covid-19.	Jun/14/2021
Intravenous immunoglobulin as an important adjunct in the prevention and therapy of coronavirus 2019 disease.	Sep/16/2021
Immunomodulation: Immunoglobulin Preparations Suppress Hyperinflammation in a COVID-19 Model via FcgammaRIIA and FcalphaRI	Jun/10/2021
Immune response to intravenous immunoglobulin in patients with Kawasaki disease and MIS-C.	Jan/15/2022
Cross-neutralization activity against SARS-CoV-2 is present in currently available intravenous immunoglobulins.	Sep/09/2020
Efficacy Evaluation of Intravenous Immunoglobulin in Non-severe Patients with COVID-19: A Retrospective Cohort Study Based on Propensity Score Matching	Jan/11/2021
Pre-COVID-19 Immunity to Common Cold Human Coronaviruses Induces a Recall-Type IgG Response to SARS-CoV-2 Antigens Without Cross-Neutralisation	Feb/11/2022
High-Dose Intravenous Immunoglobulin as a Therapeutic Option for Deteriorating Patients With Coronavirus Disease 2019	Mar/03/2022
Clinical efficacy of intravenous immunoglobulin therapy in critical ill patients with COVID-19: a multicenter retrospective cohort study.	Oct/14/2020
Potential therapeutic approach of intravenous immunoglobulin against COVID-19	Oct/09/2021
Anti-SARS-CoV-2 Antibodies Within IVIg Preparations: Cross-Reactivities With Seasonal Coronaviruses, Natural Autoimmunity, and Therapeutic Implications	Feb/17/2021
Low Humoral Immune Response and Ineffective Clearance of SARS-Cov-2 in a COVID-19 Patient With CLL During a 69-Day Follow-Up.	Jul/03/2020
A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy	Feb/16/2021
Recent Experience: Corticosteroids as a First-line Therapy in Children With Multisystem Inflammatory Syndrome and COVID-19-related Myocardial Damage	Jul/15/2021
Association of Intravenous Immunoglobulins Plus Methylprednisolone vs Immunoglobulins Alone With Course of Fever in Multisystem Inflammatory Syndrome in Children.	Feb/01/2021
Intravenous immunoglobulins in patients with COVID-19-associated moderate-to-severe acute respiratory distress syndrome (ICAR): multicentre, double-blind, placebo-controlled, phase 3 trial	Nov/11/2021
Treatment of a case of COVID-19 by intravenous immunoglobulin	Jun/30/2020
Intravenous immunoglobulin immunotherapy for coronavirus disease-19 (COVID-19).	Oct/16/2020
Intravenous immunoglobulin treatment for patients with severe COVID-19: a retrospective multicentre study.	May/19/2021
Recovery of severely ill COVID-19 patients by intravenous immunoglobulin (IVIG) treatment: A case series	Jul/07/2020
The outcome of using intravenous immunoglobulin (IVIG) in critically ill COVID-19 patients': a retrospective, multi-centric cohort study	Feb/03/2022
Intravenous Immunoglobulin may Reverse Multisystem Inflammation in COVID-19 Pneumonitis and Guillain-Barre Syndrome.	Jan/16/2021
In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors	Mar/22/2022
Hyperimmune anti-COVID-19 IVIG (C-IVIG) treatment in severe and critical COVID-19 patients: A phase I/II randomized control trial.	Jun/04/2021
Multimodality treatment in immunocompromised patients with severe COVID-19: the role of IL-6 inhibitor, intravenous immunoglobulin, and haemoperfusion.	Mar/07/2021
Currently available intravenous immunoglobulin contains antibodies reacting against severe acute respiratory syndrome coronavirus 2 antigens	May/12/2020
Could Intravenous Immunoglobulin Collected from Recovered Coronavirus Patients Protect against COVID-19 and Strengthen the Immune System of New Patients?	Apr/09/2021
SARS-CoV-2 Neutralization in Convalescent Plasma and Commercial Lots of Plasma-Derived Immunoglobulin	Nov/25/2021
Severe Coronavirus Disease 2019 That Recovered from Respiratory Failure by Treatment That Included High-dose Intravenous Immunoglobulin	Sep/30/2020
Intravenous immunoglobulin therapy in COVID-19-related encephalopathy	Oct/08/2020
Clinical outcomes of intravenous immunoglobulin therapy in COVID-19 related acute respiratory distress syndrome: a retrospective cohort study	Mar/11/2022
Intravenous immunoglobulin-based adjuvant therapy for severe COVID-19: a single-center retrospective cohort study	May/21/2021
High-Dose Intravenous Immunoglobulins in the Treatment of Severe Acute Viral Pneumonia: The Known Mechanisms and Clinical Effects.	Jul/14/2020
Clearance of the SARS-CoV-2 Virus in an Immunocompromised Patient Mediated by Convalescent Plasma without B-Cell Recovery.	Aug/18/2021
Intravenous immunoglobulin as adjuvant therapy for COVID-19: A case report and literature review	Jun/30/2021
Spike and neutralizing antibodies response to COVID-19 vaccination in haemodialysis patients.	Jul/06/2021
Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant Treatment for Multisystem Inflammatory Syndrome in Children: A Case Series	Feb/18/2022
Successful treatment with plasma exchange followed by intravenous immunoglobulin in a critically ill patient with COVID-19	Apr/07/2022
Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma	Feb/09/2021
High-dose intravenous immunoglobulins might modulate inflammation in COVID-19 patients	Jul/28/2021
Effect of regular intravenous immunoglobulin therapy on prognosis of severe pneumonia in patients with COVID-19	Dec/19/2021
A consideration of convalescent plasma and plasma derivatives in the care of Severely-ill patients with COVID-19	Mar/25/2021
Guillain-Barre Syndrome with Rapid Onset and Autonomic Dysfunction Following First Dose of Pfizer-BioNTech COVID-19 Vaccine: A Case Report	Dec/04/2022
Use of Intravenous Immunoglobulin (Prevagen or Octagam) for the Treatment of COVID-19: Retrospective Case Series.	Dec/14/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04500067	Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment	Completed	Phase 3	May/07/2020	Sep/15/2020
Alternative id - 2020-BV-BP Interventions - Drug: IVIG Study type - Interventional Study results - No Results Available Locations - Site 08 - "Central City Clinical Hospital of Ivano-Frankivsk City Council", Ivano-Frankivs'k, Ivano-Frankivs'k Region, Ukraine\|Site 02 - "Bila Tserkva City Hospital №3", Bila Tserkva, Kyiv Region, Ukraine\|Site 03 - "Lviv Regional Infectious Diseases Clinical Hospital", Lviv, Lviv Region, Ukraine\|Site 04 - "City Clinical Infectious Diseases Hospital", Odesa, Odesa, Odesa Region, Ukraine\|Site 07 - "Ternopil City Municipal Ambulance Hospital", Ternopil', Ternopil' Region, Ukraine\|Site 06 - "Vinnytsia City Clinical Hospital №1", Vinnitsia, Vinnitsia Region, Ukraine\|Site 09 - "Volyn Regional Clinical Hospital", Luts'k, Volyn Region, Ukraine\|Site 01 - "Kyiv City Clinical Hospital №17", Kyiv, Ukraine\|Site 05 - "Kyiv City Clinical Hospital №4", Kyiv, Ukraine Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 76 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Period duration (in days) to clinical improvement\|O2 saturation (SPO2 percentage), with self-breathing\|Respiratory movements rate (amount per minute), with self-breathing\|Body temperature without antipyretics use\|Lymphocyte count\|Time from the onset of the disease to discharge, in days\|Duration of the need for ventilatory support, in days\|Duration of the need for intensive care, in days\|Duration of need for oxygenation in days (SPO2 ≤ 93% with self-breathing)\|The C-reactive protein (CRP) level\|The tumor necrozis factor alpha (TNF-α) level\|The interleukin-1β (IL-1β) level\|The interleukin-6 (IL-6) level\|The D-dimer level\|The Complement (C3 component) level\|The Circulating immune complexes level\|The ferritin level\|The procalcitonin level\|IgG subtypes\|Survival assessment for a 28-day follow-up period since the onset of severe pneumonia
NCT04403269	NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE	Recruiting	Phase 2	May/05/2020	May/05/2021
Alternative id - P20/07 GERONIMO 19 Interventions - Drug: IgIV Study type - Interventional Study results - No Results Available Locations - Centre Hospitalier de Versailles, Le Chesnay, France Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 35 Age - 75 Years and older (Older Adult) Outcome measures - Mortality\|Total number of days of full hospitalization\|Duration of oxygen therapy\|Ferritin level in the blood\|CRP level in the blood\|LDH level in the blood\|Lymphocyte level in the blood\|PNN level in the blood\|platelet level in the blood\|WHO performance index\|WHOQOL-OLD questionnaire\|Lung function by pulmonary computed tomography\|Lung function by EFR\|Readmission Rates
NCT04616001	IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation	Not yet recruiting	Phase 4	Nov/01/2020	Jun/30/2021
Alternative id - COVID-IVIG VENT\|2010902 Interventions - Drug: IVIG Study type - Interventional Study results - No Results Available Locations - Sharp Memorial Hospital, San Diego, California, United States Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 10 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Hospital length of stay\|Human metabolome and proteome
NCT04891172	Anti COVID 19 Hyperimmune Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients	Recruiting	Phase 2\|Phase 3	Aug/01/2021	Aug/02/2022
Alternative id - C-IVIG-02 Interventions - Biological: Anti COVID 19 Intravenous Immunoglobulin (C-IVIG) Study type - Interventional Study results - No Results Available Locations - Dow University of Health Sciences, Karachi, Sindh, Pakistan Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Single (Participant)\|Primary Purpose: Treatment Enrollment - 310 Age - 18 Years and older (Adult, Older Adult) Outcome measures - 28 day Mortality\|Immediate and serious adverse event during hospital Stay\|Clinical Status of follow-up days according to 7-Catergory Ordinal Scale\|change in C-Reactive Protein (CRP) levels\|change in interleukin 6 (IL-6)\|change in anti-SARS-CoV-2 antibody levels\|change in Horowitz idex\|change in radiological findings
NCT04480424	Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)	Completed	Phase 2	Sep/17/2020	Oct/25/2021
Alternative id - GC2007 Interventions - Biological: GAMUNEX-C\|Drug: Standard Medical Treatment Study type - Interventional Study results - No Results Available Locations - Chandler Regional Medical Center, Chandler, Arizona, United States\|Southern California Research Center, Coronado, California, United States\|University of Illinois at Chicago, Chicago, Illinois, United States\|Via Christi Research, Wichita, Kansas, United States\|University of Louisville, Louisville, Kentucky, United States\|Louisiana State University Health Sciences Center, Shreveport, Louisiana, United States\|McLaren Flint, Flint, Michigan, United States\|McLaren Health Care-Macomb, Mount Clemens, Michigan, United States\|McLaren Health Care Oakland, Pontiac, Michigan, United States\|CHI Health, Omaha, Nebraska, United States\|Columbia University Medical Center, New York, New York, United States\|Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States\|Summa Health, Akron, Ohio, United States\|Temple University Hospital, Philadelphia, Pennsylvania, United States\|Allegheny Health Network Research Institute, Pittsburgh, Pennsylvania, United States\|CHRISTUS Health, Tyler, Texas, United States\|MultiCare Deaconess Hospital, Spokane, Washington, United States\|MultiCare Tacoma General Hospital, Tacoma, Washington, United States Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 100 Age - 18 Years and older (Adult, Older Adult) Outcome measures - All-Cause Mortality Rate Through Day 29\|Time to Actual ICU Discharge\|Duration of Mechanical Ventilation\|Time to Actual Hospital Discharge\|Duration of Any Oxygen Use\|Mean Change from Baseline in Ordinal Scale\|Absolute Value Change from Baseline in Ordinal Scale\|Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale\|Overall Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS)\|Number of Participants who Develop ARDS Distributed by Severity\|Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score\|Change from Baseline in National Early Warning Score (NEWS)\|Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours
NCT04546581	Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)	Completed	Phase 3	Oct/08/2020	May/21/2021
Alternative id - INSIGHT 013 Interventions - Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)\|Other: Placebo\|Drug: Remdesivir Study type - Interventional Study results - No Results Available Locations - Penrose Hospital, Colorado Springs, Colorado, United States\|St. Francis Health Services, Colorado Springs, Colorado, United States\|St. Anthony Hospital, Lakewood, Colorado, United States\|Saint Anthony North Health Campus, Westminster, Colorado, United States\|Washington VA Medical Center, Washington, District of Columbia, United States\|Redmond Regional Medical Center, Rome, Georgia, United States\|National Institutes of Health Clinical Center, Bethesda, Maryland, United States\|University of Massachusetts, Worcester, Massachusetts, United States\|Hennepin Healthcare Research Institute/HCMC, Minneapolis, Minnesota, United States\|University of Missouri, Columbia, Missouri, United States\|Cox Medical Centers, Springfield, Missouri, United States\|FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States\|Ohio Health Research Institute, Columbus, Ohio, United States\|Hendrick Medical Center, Abilene, Texas, United States\|CHRISTUS Spohn Shoreline Hospital, Corpus Christi, Texas, United States\|University of Texas Southwestern Medical Center, Dallas, Texas, United States\|CJW Chippenham Medical Center, Richmond, Virginia, United States\|Henrico Doctors' Hospital (HCA), Richmond, Virginia, United States\|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, Denmark\|Democritus University of Thrace, Alexandroupoli, Thrace, Greece\|3rd Dept of Medicine, Medical School, NKUA, Athens, Greece\|1st Respiratory Medicine Dept, Athens University Medical School, Athens, Greece\|Attikon University General Hospital, Athens, Greece\|Dept. of Critical Care & Pulmonary Medicine, Evangelismos General Hospital, Athens, Greece\|NCGM, Tokyo, Japan\|Fujita Health University Hospital, Toyoake, Japan\|Institute of Human Virology-Nigeria (IHVN), Abuja, Nigeria\|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain\|Hospital Universitari Vall d'Hebron, Barcelona, Catalonia, Spain\|Hospital del Mar, Barcelona, Spain\|Hospital Clínic de Barcelona, Barcelona, Spain\|Royal Free Hospital, London, United Kingdom Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 593 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Ordinal Outcome Scale - Day 7\|All-cause mortality through Day 28\|Ordinal Outcome Scale\|Change in National Early Warning Score (NEWS)\|Time to Worsening\|Discharge Status\|Days Alive Outside the Hospital\|Pulmonary-only Components of the Primary Ordinal Outcome\|Thrombotic Components of the Primary Ordinal Outcome\|Time to recovery\|Clinical Organ Dysfunction\|Safety and Tolerability - Adverse Events\|Safety and Tolerability - Infusion Reactions, Interruptions, or Cessation\|Safety and Tolerability - Serious Adverse Events\|Safety and Tolerability - Prevalence of Adverse Events\|Change in Neutralizing Antibody Level
NCT04432324	Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)	Completed	Phase 2	Jun/02/2020	Mar/03/2021
Alternative id - GC2004\|2020-001696-32 Interventions - Biological: Intravenous Immune Globulin\|Drug: Standard Medical Treatment Study type - Interventional Study results - No Results Available Locations - Hospital Universitario Infanta Sofía, San Sebastián De Los Reyes, Madrid, Spain\|Hospital Germans Trias i Pujol, Badalona, Spain\|Hospital Del Mar, Barcelona, Spain\|Hospital Universitari Vall d'Hebron, Barcelona, Spain\|Hospital Universitari de Bellvitge, Barcelona, Spain\|Hospital de la Santa Creu i Sant Pau, Barcelona, Spain\|Hospital Universitario de Getafe, Getafe, Spain\|Hospital Arnau de Vilanova, Lleida, Spain\|Hospital General Universitario Gregorio Marañón, Madrid, Spain\|Hospital Clinico San Carlos, Madrid, Spain Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 100 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Percentage of Participants Dying or Requiring ICU Admission\|Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation\|Change from Baseline in National Early Warning Score (NEWS)\|Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours\|Time to Hospital Discharge\|Duration of ICU Stay\|Duration of Any Oxygen Use\|Duration of Mechanical Ventilation\|Mean Change from Baseline in Ordinal Scale\|Absolute Value Change from Baseline in Ordinal Scale\|Length of Time to Clinical Progression\|Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale\|Time to Sustained Normalization of Temperature\|Percentage of Participants with Normalization of Fever\|Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS)
NCT04521309	SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients	Completed	Phase 1\|Phase 2	Jun/19/2020	Feb/08/2021
Alternative id - biotech001 Interventions - Biological: SARS-CoV-2 antibody based IVIG therapy Study type - Interventional Study results - No Results Available Locations - Dow University of Health Sciences, Karachi, Sindh, Pakistan Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Single (Participant)\|Primary Purpose: Treatment Enrollment - 50 Age - 18 Years and older (Adult, Older Adult) Outcome measures - 28 Days mortality\|Requirement of supplemental oxygen support\|Number of days on assisted ventilation\|Days to step down\|Days to Hospital Discharge\|Adverse events during hospital stay\|Change in C-Reactive Protein (CRP) levels\|Change in neutrophil lymphocyte ratio\|Change in Ferritin levels\|Change in lactate dehydrogenase (LDH) levels\|Change in radiological (X-ray) findings\|Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test\|Anti-SARS-CoV-2 Antibody\|Change in fever\|Change in Sodium levels\|Change in Potassium levels\|Change in Chloride levels\|Change in Bicarbonate levels
NCT04826588	Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)	Recruiting	Phase 3	May/23/2021	Jul/01/2022
Alternative id - 2021-00362; ks21Bielicki2 Interventions - Drug: Methylprednisolone sodium succinate 10 mg/kg intravenously\|Biological: Human normal immunoglobulin (IVIg)\|Drug: Methylprednisolone sodium succinate 2 mg/kg Study type - Interventional Study results - No Results Available Locations - Cantonal Hospital Aarau, Department of Paediatrics, Aarau, Switzerland\|University of Basel Children's Hospital, Basel, Switzerland\|Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica, Bellinzona, Switzerland\|Department of Pediatrics, University of Bern, Bern, Switzerland\|Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland\|Department of Pediatrics,University Hospital of Lausanne (CHUV), Lausanne, Switzerland\|Department of Pediatrics, Cantonal Hospital Luzern, Luzern 16, Switzerland\|Children's Hospital of Eastern Switzerland, St. Gallen, Switzerland\|Department of Pediatrics, Cantonal Hospital Fribourg, Villars-sur-Glâne, Switzerland\|University Children's Hospital Zuerich, Zuerich, Switzerland Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 75 Age - 44 Weeks to 18 Years (Child, Adult) Outcome measures - Hospital length of stay\|All-cause mortality among patients\|Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
NCT04383548	Clinical Study for Efficacy of Anti-Corona VS2 Immunoglobulins Prepared From COVID19 Convalescent Plasma Prepared by VIPS Mini-Pool IVIG Medical Devices in Prevention of SARS-CoV-2 Infection in High Risk Groups as Well as Treatment of Early Cases of COVID19 Patients	Not yet recruiting	Not Applicable	Jun/01/2020	Jan/01/2021
Alternative id - Mini-pooled IVIG in COVID19 Interventions - Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin Study type - Interventional Study results - No Results Available Locations - Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 100 Age - 21 Years to 50 Years (Adult) Outcome measures - Efficacy of COVID19 hyper immunoglobulins for patients\|Efficacy of COVID19 hyper immunoglobulins for high risk groups\|Safety of anti-SARS-CoV-2 hyper immunoglobulins assessed by percentage of adverse events
NCT04411667	Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19	Completed	Phase 4	Apr/28/2020	Jun/23/2020
Alternative id - COVID-IVIG\|2004902 Interventions - Drug: Octagam Study type - Interventional Study results - Has Results Locations - Sharp Grossmont Hospital, La Mesa, California, United States\|Sharp Memorial Hospital, San Diego, California, United States Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 34 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Mechanical Ventilation\|Oxygen Therapy\|Length of Stay
NCT04910269	Outpatient Treatment With Anti-Coronavirus Immunoglobulin	Recruiting	Phase 3	Aug/06/2021	Aug/01/2023
Alternative id - INSIGHT12\|2021-001663-24 Interventions - Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)\|Other: Placebo Study type - Interventional Study results - No Results Available Locations - MedStar Health Research Institute, Washington, District of Columbia, United States\|Washington DC Veterans Affairs Medical Center, Washington, District of Columbia, United States\|University of Maryland Medical System, Baltimore, Maryland, United States\|Infusion Associates, Grand Rapids, Michigan, United States\|Mount Sinai Beth Israel Hospital, New York, New York, United States\|Icahn School of Medicine at Mount Sinai, New York, New York, United States\|Hendrick Medical Center, Abilene, Texas, United States\|CHRISTUS Spohn Shoreline Hospital, Corpus Christi, Texas, United States\|UT Southwestern Medical Center, Dallas, Texas, United States\|Swedish Hospital First Hill, Seattle, Washington, United States\|Odense University Hospital, Odense, C, Denmark\|Aarhus Universitetshospital, Skejby, Aarhus, N, Denmark\|Department of Infectious Diseases, Aalborg, Denmark\|Rigshospitalet, CHIP, Copenhagen, Denmark\|Herlev/Gentofte Hospital, Hellerup, Denmark\|Hvidovre University Hospital, Department of Infectious Diseases, Hvidovre, Denmark\|Kolding Sygehus, Kolding, Denmark\|Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital, Athens, Attica, Greece\|3rd Dept of Medicine, Medical School, Athens, Attica, Greece\|4th Department of Internal Medicine, Athens, Attica, Greece\|Hospital General Dr. Manuel Gea Gonzáles, Mexico City, Cdmx, Mexico\|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Cdmx, Mexico\|Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas, Mexico City, Cdmx, Mexico\|CHRISTUS Centro de Excelencia en Investigacion (Obispado), Monterrey, NL, Mexico\|Hospital General Dr. Aurelio Valdivieso, Oaxaca City, OA, Mexico\|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain\|CAP Can Bou, Castelldefels, Barcelona, Spain\|CAP El Maresme, Mataro, Barcelona, Spain Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 820 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Clinical Status\|All-cause hospitalization or death through 28 days.\|All-cause mortality through 28 days.\|Significant Disease Progression\|Ordinal Scale Distribution\|Disease Progression Through 7 Days\|Significant Disease Progression Through 7 Days\|Disease Progression at Follow-up\|Activity Limitations at Follow-up\|Change in Viral Burden from Serum Antigen\|Change in Viral Burden from PCR\|Change in SARS-CoV-2 Antibody Concentration\|Healthcare Utilization at Follow-up\|Worst Status Through 28 Days\|Hypoxemia Through Day 7\|Additional COVID-19 Treatment

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