An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2031200174
- Lead Sponsor
- Ohmagari Norio
- Brief Summary
When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 593
1. SARS-CoV-2 infection documented by 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
2. Symptomatic COVID-19 disease
3. Duration of symptoms attributable to COVID-19 =< 12 days
4. Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
5. Age => 18 years
6. Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
7. Provision of informed consent by participant or legally authorized representative
1. Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
2. Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
3. 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
4. History of allergy to IVIG or plasma products
5. History of selective IgA deficiency with documented presence of anti-IgA antibodies
6. Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient
_Includes New York Heart Association Class III or IV stage heart failure
7. 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
8. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method