COVID-19Phase 2NCT04354831
Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients
A Phase 2 study testing anti-SARS-CoV-2 convalescent plasma in people with COVID-19, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- anti-SARS-CoV-2 convalescent plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to 10 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or older
- Hospitalized as an in-patient with positive COVID-19 test by PCR
- Presence of respiratory symptoms with any of severe features as below:
- Respiratory Rate ≥ 24/min
- Oxygen Support >3L/min by nasal cannula
- New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
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- Patient / HCPOA must agree to storage of blood specimens for future testing.
- Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
- Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.
Who cannot join
- FCBP with positive pregnancy test (mandatory)
- Breastfeeding females
- Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
- Mechanical ventilation for > 14 days
- Days from symptom onset >21 days
- Expected survival < 72 hours
- Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
- Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
Read the detailed description
This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.
- Conditions
- COVID-19
- Being tested
- anti-SARS-CoV-2 convalescent plasma
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-SARS-CoV-2 convalescent plasmaBiological
- SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL maximum dose as 7 ml/kg adjusted IBW )
- Study drug will be administered as a single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ICU Cohort | Experimental | Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. Receives: Biological: anti-SARS-CoV-2 convalescent plasma |
| Non-ICU Cohort | Experimental | Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. Receives: Biological: anti-SARS-CoV-2 convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mortality
Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
Measured: Duration of patient hospitalization, sometimes exceeding 60 days
Secondary outcomes (2)
Length of Admission After Plasma Infusion
Length of admission after convalescent plasma infusion for all patients. All enrolled patients, whether they were in the ICU cohort or in the non-ICU cohort, were monitored from the time of consent until the time of hospital discharge. Hospital discharge includes those patients who left the hospital alive and those patients who died during their stay.
Measured: Length of admission for COVID through study follow-up period
Length of ICU Stay After Convalescent Plasma Infusion
Length of ICU stay after plasma infusion for patients who were in the experimental ICU cohort
Measured: Length of admission in the ICU for COVID through study follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start11 May 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Froedtert Hospital
- Responsible party
- Principal investigator, Mary Beth Graham, MD, Medical College of Wisconsin
- Investigators
- Mary Beth Graham, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354831
- Sponsor's protocol ID
- PRO00037712
- Status last verified
- Mar 2024
- First submitted
- 14 Apr 2020
- Last updated
- 10 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04354831
- Acronym / sponsor ID
- PRO00037712
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Froedtert Hospital
- Study start
- 11 May 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Posted 10 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
Detailed description
This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
| Arm | Type | Receives |
|---|---|---|
| ICU Cohort | Experimental | Biological: anti-SARS-CoV-2 convalescent plasmaPatients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. |
| Non-ICU Cohort | Experimental | Biological: anti-SARS-CoV-2 convalescent plasmaPatients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years or older
- Hospitalized as an in-patient with positive COVID-19 test by PCR
- Presence of respiratory symptoms with any of severe features as below:
- Patient / HCPOA must agree to storage of blood specimens for future testing.
- Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
Key exclusion criteria (8 listed)
- FCBP with positive pregnancy test (mandatory)
- Breastfeeding females
- Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
- Mechanical ventilation for > 14 days
- Days from symptom onset >21 days
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 |
|---|---|---|
| anti-SARS-CoV-2 convalescent plasma* SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) * Study drug will be administered as a single intravenous infusion | Biological | ICU Cohort, Non-ICU Cohort |
Primary outcome
Overall Mortality
Time frame: Duration of patient hospitalization, sometimes exceeding 60 days
Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
2 secondary outcomes
Length of Admission After Plasma Infusion
Time frame: Length of admission for COVID through study follow-up period
Length of ICU Stay After Convalescent Plasma Infusion
Time frame: Length of admission in the ICU for COVID through study follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mary Beth Graham principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-SARS-CoV-2 convalescent plasma in people with COVID-19, run by Medical College of Wisconsin at 1 site in United States.
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 9 inclusion and 8 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 10 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Mortality (time frame: Duration of patient hospitalization, sometimes exceeding 60 days). 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 10 Apr 2024.