Please select the eligibility criteria that correspond to the clinical trial below.
Title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
Brief Summary: Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.


Options:
A: Inclusion Criteria:

* age \>=18 yrs
* positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
* Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
* Polymerase chain reaction (PCR) increased by 3.5 with respect to baseline or \>1.8 mg/dl
* need for mechanical ventilation or continuous positive airway pressure (CPAP)
* signed informed consent unless unfeasible for the critical condition

Exclusion Criteria:

* Moderate to severe ARDS lasting more than 10 days
* proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
* consent denied
B: Inclusion Criteria:

* Age at least 18 years
* Laboratory confirmed diagnosis of infection with SARS-CoV-2
* Admitted to an acute care facility for the treatment of COVID-19 complications
* Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
* Informed consent provided by the patient or healthcare proxy

Severe COVID-19 is defined by one or more of the following:

* dyspnea
* respiratory frequency ≥ 30/min
* blood oxygen saturation ≤ 93%
* partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
* lung infiltrates \> 50% within 24 to 48 hours

Life-threatening COVID-19 is defined as one or more of the following:

* respiratory failure
* septic shock
* multiple organ dysfunction or failure

Exclusion Criteria:

* None
C: Inclusion Criteria:

* (fulfill all criteria): male or female patients 18 years or older
* written informed consent by patient or next of kin (if patients too ill)
* diagnosis of H1N1 2009 infection satisfying both clinical and laboratory criteria:

  1. Laboratory criteria: at least one RT-PCR positive for H1N1 2009 from one of the clinical specimens (NPA, ETA, blood, urine or stool).
  2. Clinical criteria: patients admitted to ICU with severe community acquired pneumonia as defined by a CURB-65 score of 3 or more
* deterioration during treatment with optimal antiviral (oral or inhaler agents only) and typical and atypical antimicrobial coverage
* required ICU and ventilatory support and within 7 days onset of symptoms.

Exclusion Criteria:

* age below 18 years
* known hypersensitivity to immune globulin or any components of the formulation
* known IgA deficiency
* acquire the H1N1 2009 infection from health care facility
* moribund patients or refusal of informed consent.
D: Inclusion Criteria:

* Signed informed consent
* Locally determined positive influenza test (by polymerase chain reaction \[PCR\] or other nucleic acid test, or by rapid antigen \[Ag\]) from a specimen obtained within 2 days prior to randomization
* Onset of illness no more than 7 days before randomization, defined as when the participant first experienced at least one respiratory symptom or fever
* Hospitalized (or in observation unit) for influenza, with anticipated hospitalization for more than 24 hours. Criteria for hospitalization will be up to the individual treating clinician.
* For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least one form of hormonal or barrier contraception through Day 28 of the study
* Willingness to have blood and respiratory samples obtained and stored
* NEW score greater than or equal to 2 at screening (see the protocol for more information on this criterion)

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin
* Prior treatment with any investigational drug therapy within 30 days prior to screening
* History of allergic reaction to blood or plasma products (as judged by the site investigator)
* Known immunoglobulin A (IgA) deficiency
* A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the participant at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)
* Presence of any pre-existing illness that, in the opinion of the site investigator, would place the participant at an unreasonably increased risk through participation in this study
* Participants who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol
* Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the participant (e.g., decompensated congestive heart failure)
* Receiving extracorporeal membrane oxygenation (ECMO)
* Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)

Answer: D