Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kamada, Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥ 18 years
2. Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR)
3. Hospitalized for COVID-19 pneumonia
4. Dosing should be within 10 days of symptom start
5. Able and willing to sign informed consent form
You may not be if
1. History of hypersensitivity to plasma products and/or severe Immunoglobulin A deficiency (\< 7 mg/dL)
2. Requirement of high flow oxygen devices, or non-invasive ventilation or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening
3. Cardiovascular instability
4. History of thrombo-embolic events
5. Acute renal failure or creatinine \>2 mg/dL or estimated estimated glomerular filtration rate (eGFR) \<30 mL/min
6. History of lung transplantation
7. Major surgery (abdominal and chest) within the last 4 weeks
8. Severe chronic background disease, per investigator's judgement for example, Cirrhosis grade C, Dialysis, cardiac insufficiency (NYHA III), pulmonary disease (FEV1\<50 percent of predicted) etc.
9. Pregnancy or lactation
10. Treatment with plasma units or immunoglobulin preparations within the last 4 weeks
11. Participation in another pharmaceutical interventional clinical study within 4 weeks from screening
Clareo Health | Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
