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OpenTrials
Completed

NCT Number: NCT04550325

Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Wolfson Medical Center, Holon, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kamada Anti-SARS-CoV-2

Biological

Anti-SARS-CoV-2 is a preparation of immune gamma globulin manufactured from convalescent plasma of COVID-19 recovered patients, using Kamada's proprietary purification methods

Primary outcomes

  1. Adverse events, serious adverse events, and deaths

    Time frame: 14 days

    Record adverse events, serious adverse events, and deaths

  2. Adverse events, serious adverse events, and deaths

    Time frame: 28 days

    Record adverse events, serious adverse events, and deaths

Secondary outcomes

  1. AUC0-7 of Anti SARS CoV-2 antibodies

    Time frame: 7 days

    Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin

  2. Neutralization activity

    Time frame: 7 days

    Evaluate virus neutralization activity of patient's plasma

Other outcomes

  1. Duration of Hospitalization

    Time frame: 84 days

    Time patient spent in hospital

  2. Clinical status on the 6 point ordinate scale

    Time frame: 84 days

    Score on the 6 point ordinate scale

Sponsors and collaborators

Lead sponsor

Kamada, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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