Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: 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
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:

* Patient older than 18 years
* CALL score ≥ 9 (progression risk score)
* PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact)
* Any symptoms of COVID-19 infection
* Admission due to COVID-19 infection
* Signed informed consent
* ECOG before COVID-19 infection 0-2

Exclusion Criteria:

* PaFi \<200 or mechanical ventilation indication
* Clinically relevant co-infection at admission
* Pregnancy or lactation
* IgA deficiency or IgA nephropathy
* Immunoglobulin or plasma administration in the last 60 days
* Contraindication to transfusion or previous allergy to blood-derived products
* Do-not-resuscitate status
* Patients receiving other investigational drug for COVID-19 in a clinical trial
* Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.
D: Inclusion Criteria:s

1. Recipients:

   We will use the confirmed case definition of SARS-CoV-2 infection (COVID-19) with POSITIVE rRT PCR test for SARS-CoV-2 "using one of the SFDA approved kit used in KSA" as per current MOH / SCDPC (Waqayah) guidelines (derived from WHO and CDC ).
   1. 18 or older
   2. Patient with COVID 19 confirmed as per case definition of CDC or MOH/Waqayah
   3. Must have been requiring ICU care or severe or immediately life-threatening care:

   i. Patient requiring ICU admission. ii. Severe disease is defined as:
   1. Dyspnea
   2. Respiratory frequency ≥ 30/min
   3. Blood oxygen saturation ≤ 93%
   4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or Lung infiltrates \> 50% within 24 to 48 hours iii. Life-threatening disease is defined as:

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   1. Respiratory failure
   2. Septic shock, and/or
   3. Multiple organ dysfunction or failure
2. Donors:

   1. 18 or older
   2. Recovery from Prior confirmed COVID-19 diagnosis through NEGATIVE rRT PCR test for SARS-CoV-2 from blood or nasopharyngeal swab - FDA IND guidance or the MOH updated recovery protocol 15.20.22.23
   3. Complete Clinical Recovery from COVID-19 at least 14 days prior to donation (FDA IND guidance15)
   4. All MOH criteria for a fit donor will be followed prior to donation.
   5. All Transfusion Transmissible Infections (TTI) markers on the donor blood are negative as per current MOH routine donor screening regulations

Exclusion Criteria:

1. Recipients:

   1. Negative or non-conclusive test COVID-19 rRT PCR test for SARS-CoV-2
   2. Mild symptoms
   3. Hospitalization not requiring ICU admission
2. Donors:

   1. Unfit to donate.
   2. Multiparous or pregnant females.

Answer: B