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CoronavirusEarly Phase 1NCT04340050

COVID-19 Convalescent Plasma

A Early Phase 1 study testing anti-SARS-CoV-2 convalescent plasma in people with Coronavirus, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus
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
10 participants
Where
1 siteUnited States
Study dates
10 Apr 2020to 23 Dec 2020
Phase
Early Phase 1
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

Donor Inclusion Criteria:

  • Age greater or equal to 18
  • Able to donate blood per blood bank standard guidelines
  • Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
  • Complete resolution of symptoms at least 28 days prior to donation
  • Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors

Donor Exclusion Criteria:

  • Does not provide consent
  • Does not meet standard blood bank donation guidelines
  • Unsuccessful blood donation

Recipient Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Must have laboratory-confirmed COVID-19
  • Must have severe or immediately life-threatening COVID-19
  • Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
  • Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
  • Must be less than 21 days from the start of illness
  • Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
  • Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
  • Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma

Recipient Exclusion Criteria:

  • Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
  • Receipt of pooled immunoglobulin in past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products
  • Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Medicine

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.

Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.

Read more

Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.

Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

Conditions
Coronavirus
Being tested
anti-SARS-CoV-2 convalescent plasma
Keywords
COVID19
Medical subject headings
Coronavirus Infections, 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

    Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours

Study groups in NCT04340050
Study groupRoleWhat they receive
Treatment with anti-SARS-CoV-2 convalescent plasmaExperimentalInfusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours
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.

  1. Success of Administering Plasma

    Number of patients who receive convalescent plasma

    Measured: At time of administration

  2. Type of Respiratory Support

    Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

    Measured: Until discharge from hospital

Secondary outcomes (8)

  1. Cardiac Arrest

    Number of patients experiencing cardiac arrest.

    Measured: 28 days after plasma administration

  2. Transfer to ICU

    Number of patients transferred to ICU

    Measured: 28 days

  3. ICU Mortality

    Number of patients dying in the ICU

    Measured: Until discharge

  4. ICU Length of Stay

    This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.

    Measured: Up to 50 days

  5. Hospital Mortality

    Mortality during course of illness

    Measured: Until discharge

  6. Hospital Length of Stay

    This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.

    Measured: Until discharge

  7. Ventilator-free Days

    This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.

    Measured: 28 days

  8. Overall Survival (28-day Mortality)

    28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2020
  2. Study start10 Apr 2020
  3. Primary completion23 Dec 2020
  4. Study completion23 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04340050
Sponsor's protocol ID
IRB20-0523
Status last verified
Feb 2024
First submitted
7 Apr 2020
Last updated
28 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We will share individual participant data that is de-identified available to all qualified investigators

Publications

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PubMed 37162745

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PubMed 36734509

  • Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

    PubMed 34013969

  • Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

    PubMed 33044747

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing anti-SARS-CoV-2 convalescent plasma in people with Coronavirus, run by University of Chicago 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?

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 28 Feb 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 28 Feb 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?

Success of Administering Plasma (time frame: At time of administration). 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?

On the ClinicalTrials.gov record for NCT04340050, which also lists 4 linked publications.

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 28 Feb 2024.

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