COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04480424

Rhonda Griffin

rhonda.griffin@grifols.com;

2020-07-21

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: hospitalized male or female subjects of ≥ 18 years of age at time of screening who are being treated in the icu for covid-19 for not longer than 48 hours or for whom a decision has been made that covid-19 disease severity warrants icu admission. has laboratory-confirmed novel coronavirus {sars-cov-2} infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other united states food and drug administration (fda)-approved diagnostic assay for covid-19 in any specimen during the current hospital admission prior to randomization. illness (symptoms of covid-19 of any duration requiring icu level care), and the following: radiographic infiltrates by imaging (chest x-ray, computerized tomography (ct) scan, etc.), and requiring mechanical ventilation and/or supplemental oxygen. 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 provides informed consent prior to initiation of any study procedures.

- clinical evidence of any significant acute or chronic disease or pathophysiologic manifestations (eg, complications of covid-19 standard medical treatments) 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 a past history of any hypersensitivity reactions to commercial immunoglobulin. - 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. - subjects with known (documented) thrombotic complications to polyclonal ivig therapy in the past. - subjects with current or prior myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event (within the past 12 months) or who have a history of thromboembolic events of unknown etiology. - subjects with limitations of therapeutic effort. - female subjects 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. - subjects participating in another interventional clinical trial with investigational medical product or device. - known history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome. - presence of malignancy (either new diagnosis of malignancy or known residual disease) within the past 12 months. - creatinine at screening is ≥ 4 mg/dl (or subject is dependent on dialysis/renal replacement therapy). - known immunoglobulin a (iga) deficiency with anti-iga serum antibodies. - uncontrolled hypertension at the time of screening (systolic blood pressure > 200 mm hg) or refractory severe hypotension with sustained systolic blood pressure < 90 mm hg unresponsive to vasopressors.

2

Grifols Therapeutics LLC

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

100

All-Cause Mortality Rate Through Day 29

None

Phase 2

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