Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)
Lead Sponsor:
Instituto Grifols, S.A.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Hospitalized male or female subject ≥ 18 years of age at time of Screening who is being treated for COVID-19.
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase \[RT\]-PCR), or other commercial or public health assay (of any type) in any specimen during the current hospital admission prior to randomization.
- COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging (Chest X-Ray, Computed tomography (CT) scan, etc.).
- PaO2/FIO2 ratio \> 300 to ≤ 450 mmHg (i.e., arterial oxygen in mmHg divided by fraction inspired oxygen concentration \[e.g., 0.21 for room air\])
- Any one of the following related to COVID-19: i. Ferritin \> 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) \> 300 units per liter U/L, iii. D-Dimers \> reference range, or iv. C-reactive protein (CRP) \> 40 milligram per liter (mg/L).
- Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides oral informed consent prior to initiation of any study procedures.
- Exclusion criteria:
- Subject requires invasive mechanical ventilation or ICU admission.
- Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator may place the subject at undue medical risk.
- The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin.
- Subject has known (documented) hereditary fructose intolerance (HFI).
- A medical condition in which the infusion of additional fluid is contraindicated.
- Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
- Subject with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
- Subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event.
- Subject with limitations of therapeutic effort (eg, 'do not resuscitate' status).
- Female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline.
- Subject participating in another interventional clinical trial with investigational medical product or device.
Exclusion
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04432324
Start Date
June 2 2020
End Date
March 3 2021
Last Update
March 10 2021
Active Locations (10)
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1
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain, 28702
2
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
3
Hospital Del Mar
Barcelona, Spain, 08003
4
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035