COVID-19Phase 2NCT04389710
Convalescent Plasma for the Treatment of COVID-19
A Phase 2 study testing Convalescent Plasma in people with COVID-19, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. 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?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 7 Dec 2020
- Phase
- Phase 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 and older
- Laboratory confirmed diagnosis of SARS-CoV-2
- Admitted to an acute care facility for the treatment of COVID-19 complications
- Informed consent provided by patient or legally authorized representative
- Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
- Severe Disease defined as any of the following
Show all 15Show fewer
- Dyspnea
- Respiratory rate > 30/minute
- Oxygen saturation <94%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
- Lung infiltrates >50% within 24 to 48 hours
- Life-threatening disease defined as any of the following
- Respiratory failure
- Septic shock
- Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy
Who cannot join
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Convalescent Plasma for the Treatment of Patients With COVID-19
This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
Read the detailed description
This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).
- Conditions
- COVID-19
- Being tested
- Convalescent Plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaDrug
One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr Receives: Drug: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
Number of patients who are consented and ultimately receive convalescent plasma transfusion.
Measured: 1 year
Secondary outcomes (12)
Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19
Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection
Measured: 0, 1, 2, 3, 7, 14 days
Length of hospital stay
Days of hospitalization
Measured: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of Intensive Care Unit stay
Days of Intensive Care Unit management
Measured: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of intubation
Days of intubation requirement
Measured: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Survival to discharge
Proportion of patients who are successfully discharged from acute care facility
Measured: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Changes in complete blood count in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measured: 0 and 7 days
Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma
BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measured: 0 and 7 days
Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measured: 0 and 7 days
Changes in d-dimer in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measured: 0 and 7 days
Changes in fibrinogen in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measured: 0 and 7 days
Changes in prothrombin time (PT) in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measured: 0 and 7 days
Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Measured: 0 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start15 Apr 2020
- Primary completion3 Nov 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Provide access to COVID-19 convalescent plasma for patients infected with SARS-CoV-2 currently hospitalized in acute care facilities
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389710
- Sponsor's protocol ID
- 20D.379
- Status last verified
- Jun 2021
- First submitted
- 27 Apr 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma for the Treatment of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04389710
- Acronym / sponsor ID
- 20D.379
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 15 May 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.
This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
Detailed description
This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Provide access to COVID-19 convalescent plasma for patients infected with SARS-CoV-2 currently hospitalized in acute care facilities
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Convalescent PlasmaParticipants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 years and older
- Laboratory confirmed diagnosis of SARS-CoV-2
- Admitted to an acute care facility for the treatment of COVID-19 complications
- Informed consent provided by patient or legally authorized representative
- Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
Key exclusion criteria (2 listed)
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
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 |
|---|---|---|
| Convalescent PlasmaOne to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma | Drug | Intervention Group |
Primary outcome
Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
Time frame: 1 year
Number of patients who are consented and ultimately receive convalescent plasma transfusion.
12 secondary outcomes
Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19
Time frame: 0, 1, 2, 3, 7, 14 days
Length of hospital stay
Time frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of Intensive Care Unit stay
Time frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of intubation
Time frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Survival to discharge
Time frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Changes in complete blood count in patients after receiving convalescent plasma
Time frame: 0 and 7 days
Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma
Time frame: 0 and 7 days
Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma
Time frame: 0 and 7 days
Changes in d-dimer in patients after receiving convalescent plasma
Time frame: 0 and 7 days
Changes in fibrinogen in patients after receiving convalescent plasma
Time frame: 0 and 7 days
Changes in prothrombin time (PT) in patients after receiving convalescent plasma
Time frame: 0 and 7 days
Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma
Time frame: 0 and 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 4 Jun 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.
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 Convalescent Plasma in people with COVID-19, run by Thomas Jefferson University 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 15 inclusion and 2 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 4 Jun 2021. 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?
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?
Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2 (time frame: 1 year). 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 4 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.