Covid19Phase 1/2NCT04550325
Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
A Phase 1/2 study testing Kamada Anti-SARS-CoV-2 in people with Covid19 and Pneumonia, Viral, run by Kamada, Ltd. at 4 sites in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Pneumonia, Viral
- What is being tested?
- Kamada Anti-SARS-CoV-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesIsrael
- Study dates
- 5 Aug 2020to 26 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Wolfson Medical Center
Holon, 5822012
Hadassah Medical Center
Jerusalem, 91120
Sheba Medical Center Hospital- Tel Hashomer
Ramat Gan, 52621
Kaplan Medical Center
Rehovot, 7661041
About this study
Official 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
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
- Conditions
- Covid19, Pneumonia, Viral
- Being tested
- Kamada Anti-SARS-CoV-2
- Medical subject headings
- COVID-19, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kamada Anti-SARS-CoV-2Biological
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
| Study group | Role | What they receive |
|---|---|---|
| Immune gamma globulin (IgG) | Experimental | Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion Receives: Biological: Kamada Anti-SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, serious adverse events, and deaths
Record adverse events, serious adverse events, and deaths
Measured: 14 days
Adverse events, serious adverse events, and deaths
Record adverse events, serious adverse events, and deaths
Measured: 28 days
Secondary outcomes (2)
AUC0-7 of Anti SARS CoV-2 antibodies
Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin
Measured: 7 days
Neutralization activity
Evaluate virus neutralization activity of patient's plasma
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start5 Aug 2020
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Phase 1/2 Open Label, 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamada, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550325
- Sponsor's protocol ID
- Kamada Anti-SARS-CoV-2-001
- Status last verified
- Jan 2021
- First submitted
- 10 Sep 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04550325
- Acronym / sponsor ID
- Kamada Anti-SARS-CoV-2-001
- Conditions
- Covid19, Pneumonia, Viral
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kamada, Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Phase 1/2 Open Label, 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
| Arm | Type | Receives |
|---|---|---|
| Immune gamma globulin (IgG) | Experimental | Biological: Kamada Anti-SARS-CoV-2Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kamada Anti-SARS-CoV-2Anti-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 | Biological | Immune gamma globulin (IgG) |
Primary outcome
Adverse events, serious adverse events, and deaths
Time frame: 14 days
Record adverse events, serious adverse events, and deaths
Adverse events, serious adverse events, and deaths
Time frame: 28 days
Record adverse events, serious adverse events, and deaths
2 secondary outcomes
AUC0-7 of Anti SARS CoV-2 antibodies
Time frame: 7 days
Neutralization activity
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Kamada Anti-SARS-CoV-2 in people with Covid19 and Pneumonia, Viral, run by Kamada, Ltd. at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events, serious adverse events, and deaths (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.