Polyvalent Immunoglobulin in COVID-19 Related ARds (ICAR)
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ClinicalTrials.gov Identifier: NCT04350580 |
Recruitment Status :
Completed
First Posted : April 17, 2020
Last Update Posted : August 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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Acute Respiratory Distress Syndrome COVID-19 | Drug: Human immunoglobulin Drug: Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 146 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The participant will be randomized to either the group of treatment with IVIG or the placebo group. Participants in the treatment group will receive infusions of polyvalent immunoglobulins for 4 consecutive days. Participants in the placebo group will receive an equivalent volume of sodium chloride 0.9% for the same duration. |
Masking: | Double (Participant, Care Provider) |
Masking Description: | The double blinding will be provided by the hospital pharmacy of each establishment with the help of opaque sleeves to mask the product packaging and should be returned to the pharmacy when empty. |
Primary Purpose: | Treatment |
Official Title: | Value of Early Treatment With Polyvalent Immunoglobulin in the Management of Acute Respiratory Distress Syndrome Associated With SARS-CoV-2 Infections |
Actual Study Start Date : | April 11, 2020 |
Actual Primary Completion Date : | November 20, 2020 |
Actual Study Completion Date : | February 20, 2021 |

Arm | Intervention/treatment |
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Experimental: Intervention - IGIV
Participants in the intervention group will receive a 2g/Kg infusion of human immunoglobulin which should be started before the 96th hours after the start of mechanical ventilation in 4 injections of 0.5 g/Kg over 4 consecutive days.
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Drug: Human immunoglobulin
Human immunoglobulin 2g/kg over 4 days (0.5g/kg/d)
Other Name: Clairyg |
Placebo Comparator: Placebo
Participants of the placebo group will receive an equivalent volume of sodium chloride 0.9% for the same duration.
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Drug: Placebo
Sodium chloride 0.9% in the same volume and over the same time as the immunoglobulin
Other Name: Sodium chloride 0.9% |
- Ventilator-free days [ Time Frame: 28 days ]Sum of the days the patient did not receive VM, but if death occurs before D28, the score is zero
- Mortality [ Time Frame: 28 and 90 days ]Vital status at 28 and 90 days
- Sequential Organ Failure Assessment Score [ Time Frame: Days 1, 3, 7, 14, 21 and 28 ]Used to determine the extent of a person's organ function or rate of failure, from 0 to 24, with severity increasing the higher the score
- P/F ratio [ Time Frame: Days 1, 3, 7, 14, 21 and 28 ]Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage)
- Lung compliance [ Time Frame: Days 1, 3, 7, 14, 21 and 28 ]Measure of lung compliance
- Radiological score [ Time Frame: Days 1, 3, 7, 14, 21 and 28 ]Severity scoring of lung oedema on the chest radiograph
- Biological efficacy endpoints - C-reactive protein [ Time Frame: Days 1, 3, 7, 14, 21 and 28 ]Concentration in mg/L
- Biological efficacy endpoints - Procalcitonin [ Time Frame: Days 1, 3, 7, 14, 21 and 28 ]Concentration in microgram/L
- Immunological profile [ Time Frame: Up to 28 days ]Number of CD4 HLA-DR+ and CD38+, CD8 lymphocytes
- Number of patients using other treatments for COVID-19 related ARDS [ Time Frame: Up to 28 days ]Use of corticosteroids, antiretroviral, chloroquine
- Occurrence of deep vein thrombosis or pulmonary embolism [ Time Frame: 28 days ]Diagnosis of deep vein thrombosis or pulmonary embolism through imaging exam (eg ultrasound and CT scan)
- Total duration of mechanical ventilation, ventilatory weaning and curarisation [ Time Frame: 28 days ]Total time of mechanical ventilation, weaning and use of neuromuscular blockade
- Kidney Disease: Improving Global Outcomes (KDIGO) score and need for dialysis [ Time Frame: 28 days ]Divided in 3 stages, with higher severity of kidney injury in higher stages
- Occurrence of adverse event related to immunoglobulins [ Time Frame: 28 days ]Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)
- Occurrence of critical illness neuromyopathy [ Time Frame: Up to 28 days ]Medical research council sum score on awakening
- Occurrence of ventilator-acquired pneumonia [ Time Frame: Up to 28 days ]Radiological and clinical context associated with a bacteriological sampling in culture of tracheal secretions, bronchiolar-alveolar lavage or a protected distal sampling

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Any patient in intensive care:
- Receiving invasive mechanical ventilation for less than 72 hours
- ARDS meeting the Berlin criteria
- PCR-proven SARS-CoV-2 infection
- Patient, family or deferred consent (emergency clause)
- Affiliation to a social security scheme (or exemption from affiliation)
Exclusion Criteria:
- Allergy to polyvalent immunoglobulins
- Pregnant woman or minor patient
- Known IgA deficiency
- Patient with renal failure on admission defined by a 3 times baseline creatinine or creatinine >354 micromol/L or a diuresis of less than 0.3 mL/Kg for 24 hours or anuria for 12 hours
- Participation in another interventional trial

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350580

Study Chair: | Tarek Sharshar, MD, PHD | Centre Hospitalier Sainte Anne | |
Principal Investigator: | Aurélien Mazeraud, MD, PHD | Centre Hospitalier Sainte Anne |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Centre Hospitalier St Anne |
ClinicalTrials.gov Identifier: | NCT04350580 |
Other Study ID Numbers: |
D20-P013 2020-001570-30 ( EudraCT Number ) |
First Posted: | April 17, 2020 Key Record Dates |
Last Update Posted: | August 19, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
acute respiratory distress syndrome COVID-19 SARS-CoV-2 Immunoglobulin |
COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury Immunoglobulins Immunoglobulins, Intravenous Antibodies Immunologic Factors Physiological Effects of Drugs |