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:

* 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)
B: Inclusion Criteria:

* Diagnosis of influenza A or B within 72 hours prior to enrollment (by local assay including rapid antigen, direct fluorescent antibody (DFA), polymerase chain reaction (PCR), or culture, and must be able to detect and distinguish influenza A from influenza B)
* Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).
* Abnormal respiratory status, defined as room air saturation of oxygen (SaO2) less than 93% or tachypnea (respiratory rate above an age adjusted normal range)
* Agree to the storage of specimens and data
* ABO compatible plasma available on site or available within 24 hours after randomization with activity against locally circulating strains of influenza

Exclusion Criteria:

* Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to receive any time during the study). This does not include licensed drugs at non approved doses, off-label indications, or drugs available under an Emergency Use Authorization (EUA).
* History of severe allergic reaction to blood products (as judged by the investigator).
* Medical conditions for which receipt of 500 mL volume (or 8 mL/kg for pediatric patients) may be dangerous to the subject (e.g. decompensated congestive heart failure \[CHF\], etc.)
* Clinical suspicion that etiology of acute illness is primarily due to a condition other than active influenza virus replication (e.g., a bacterial or fungal infection)
C: Inclusion Criteria:

* 49 critically-ill COVID-19 patients are included.
* All of the patients were with pneumonia and residing in RCU
* Age ≥ 18 y
* With dyspnea and oxygen saturation less than 90% in resting state.
* At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators.
* All of the patients were residing in infectious diseases wards before being transferred to RCU.

Exclusion Criteria:

* The exclusion criteria of the COVID-19 patients were:

  * Previous allergic history to plasma or its ingredients such as sodium citrate.
  * Cases with serious general conditions, such as severe organ dysfunction, that are not suitable for transfusion.
  * Very late stage of the acute respiratory distress (ARDS) where Convalescent plasma (CP) has proved to be of low therapeutic benefit
D: Inclusion Criteria:

- Age ≥ 75 or age 65-74 with at least 1 of the following comorbidities: arterial hypertension, diabetes, obesity, chronic obstructive pulmonary disease, heart disease, chronic kidney disease

* Last 48 hours: (A)Axillary temperature ≥ 37.5oC or febrile equivalent, combined with (a) dry cough and/or (b) breathing difficulty and/or (c) odinophagia and/or (d) anosmia/dysgeusia and/or (e) any of the following symptoms: fatigue, anorexia, myalgias or rhinorrhea.
* Confirmed diagnosis SARS-Cov2 by RT-PCR
* Give Informed consent

Exclusion Criteria:

* Severe respiratory disease
* Cardiac insufficiency,
* Chronic renal failure,
* Primary hypogammaglobulinemias,
* Myelodysplastic syndromes,
* Chronic linfoproliferative syndromes,
* Monoclonal gammapathies,
* Known hypersensitibility,
* Active cancer,
* HIV, HBV or HCV infection,
* Chronic administration of immunosuppressants,
* Body transplant history,
* Chronic liver disease, Chronic lung disease with oxygen requirement.

Answer: A