Clinical trial: A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients (NCT04847141)

Eligibility criteria:
Inclusion Criteria:

          1. Ambulatory male or female outpatients ≥ 50 years of age who have laboratory-confirmed
             severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined
             by qualitative PCR (reverse transcriptase (RT)-PCR), or other commercial or public
             health assay approved by regulatory authorities as a diagnostic test for COVID-19
             (inclusive of SARS-CoV-2 antigen testing or other approved rapid testing platforms) in
             any specimen ≤ 5 days prior to randomized treatment.

          2. Asymptomatic with no constitutional COVID-19 illness (evident symptoms), specifically
             no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache
             that is unrelated to pre-existing conditions (example, migraine), sore throat that is
             unrelated to other pre-existing medical conditions (example, allergies,
             gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with
             previous medical condition, or evidence of pneumonia at Screening.

          3. Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air >
             94% (i.e., 95% to 100%) at Screening.

          4. National Early Warning Score (NEWS) ≤ 2 points at Screening.

          5. Subject provides informed consent (ICF) prior to initiation of any study procedures.

        Exclusion Criteria:

          1. Subjects who are admitted to hospital or for whom hospital admission is being planned
             at the time of Screening.

          2. Subjects requiring any form of oxygen supplementation at Screening.

          3. Concurrent or planned treatment with other agents with actual or possible direct
             antiviral activity against SARS-CoV-2 including remdesivir.

          4. Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against
             SARS-CoV-2

          5. Have participated in a previous SARS-CoV-2 vaccine study OR outside of a study have
             received any SARS-CoV-2 vaccine of any kind.

          6. Have a history of convalescent COVID-19 plasma treatment at Screening.

          7. Fever (temperature >38.0° C [>100.4° F]), requirement for antipyretics to reduce
             temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at
             Screening.

          8. Clinical evidence of any significant acute or chronic disease that, in the opinion of
             the investigator, may place the subject at undue medical risk for study treatment.

          9. The subject has had a known (documented) history of serious anaphylactic reaction to
             blood, any blood-derived plasma product or commercial immunoglobulin, or has known
             selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.

         10. Decompensated congestive heart failure or renal failure with fluid overload. This
             includes currently uncontrolled congestive heart failure New York Heart Association
             Class III or IV stage heart failure.

         11. Subjects for whom there is limitation of therapeutic effort such as "Do not
             resuscitate" status.

         12. Currently participating in another interventional clinical trial with investigational
             medical product or device.

         13. Subjects with known (documented) thrombotic complications to polyclonal intravenous
             immune globulin (IVIG) therapy in the past.

         14. Subject has medical condition (other than COVID-19) that is projected to limit
             lifespan to ≤ 1 year.

         15. Subject has history of drug or alcohol abuse within the past 12 months.

         16. Women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to
             practice a highly effective method of contraception (oral, injectable, or implanted
             hormonal methods of contraception, placement of an intrauterine device or intrauterine
             system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male
             sterilization, or true abstinence) throughout the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction