COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04546581

James Neaton, PhD

Jacqueline Nordwall, jacquie@ccbr.umn.edu (PI email not reported)

2020-09-14

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - sars-cov-2 infection documented by polymerase chain reaction (pcr) or other nucleic acid test (nat) within 3 days prior to randomization or documented by nat more than 3 days prior to randomization and progressive disease suggestive of ongoing sars-cov-2 infection - symptomatic covid-19 disease - duration of symptoms attributable to covid-19 ≤ 12 days - requiring inpatient hospital medical care for clinical manifestations of covid-19 (admission for public health or quarantine only is not included) - willingness to abstain from participation in other covid-19 treatment trials until after study day 7 - provision of informed consent by participant or legally authorized representative

prior receipt of sars-cov-2 hivig or convalescent plasma from a person who recovered from covid-19 at any time prior receipt of standard ivig (not hyperimmune to sars-cov-2) within 45 days current or predicted imminent (within 24 hours) requirement for any of the following: invasive ventilation non-invasive ventilation extracorporeal membrane oxygenation mechanical circulatory support continuous vasopressor therapy history of allergy to ivig or plasma products history of selective iga deficiency with documented presence of anti-iga antibodies any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes new york association class iii or iv stage heart failure) any of the following thrombotic or procoagulant disorders: acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments

2

University of Minnesota

18

100

Denmark;Greece;Japan;Nigeria;Spain;United Kingdom;United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

593

Ordinal Outcome Scale - Day 7;Primary Safety Outcome - Death, SAE or Grade 3 or 4 Events Through Day 7

None

Phase 3

[{"arm_notes": "", "treatment_id": 610, "treatment_name": "Hyperimmune immunoglobulin to sars-cov-2 (hivig)", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]