NCT04550325CompletedPhase 1
A Phase 1/2 Open Label, Multicenter, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients With Pneumonia
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kamada, Ltd.
- Enrollment
- 12
- Locations
- 8
- Primary Endpoint
- Adverse events, serious adverse events, and deaths
Study Overview
Brief Summary
Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR)
- •Hospitalized for COVID-19 pneumonia
- •Dosing should be within 10 days of symptom start
- •Able and willing to sign informed consent form
Exclusion Criteria
- •History of hypersensitivity to plasma products and/or severe Immunoglobulin A deficiency (< 7 mg/dL)
- •Requirement of high flow oxygen devices, or non-invasive ventilation or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening
- •Cardiovascular instability
- •History of thrombo-embolic events
- •Acute renal failure or creatinine >2 mg/dL or estimated estimated glomerular filtration rate (eGFR) <30 mL/min
- •History of lung transplantation
- •Major surgery (abdominal and chest) within the last 4 weeks
- •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.
- •Pregnancy or lactation
- •Treatment with plasma units or immunoglobulin preparations within the last 4 weeks
- •Participation in another pharmaceutical interventional clinical study within 4 weeks from screening
Outcomes
Primary Outcomes
Adverse events, serious adverse events, and deaths
Time Frame: 28 days
Record adverse events, serious adverse events, and deaths
Secondary Outcomes
- Neutralization activity(7 days)
- AUC0-7 of Anti SARS CoV-2 antibodies(7 days)
Investigators
Study Sites (8)
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