Covid19NCT04471051
An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients
An observational study of Covid19, run by University of Colorado, Denver at 6 sites in United States.
Trial summary
This is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 255 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Apr 2020to 20 Aug 2020
- Phase
- Observational
- 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
Study population: Hospitalized patients treated with anti-SARS-CoV-2 convalescent plasma under the Expanded Access protocol NCT04372368. Patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. This observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol.
Who may be able to join
- Age 18 years or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- Patient treated with COVID19 convalescent plasma.
- Patient or surrogate designated decision maker is willing and able to provide written informed consent.
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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
UCHealth Memorial Hospital North
Colorado Springs, Colorado, 80920
Denver Health Medical Center
Denver, Colorado, 80204
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
About this study
This is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Information about patient recovery will be collected from participants' electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with convalescent plasma under a separate expanded access protocol, NCT04372368.
Read the detailed description
This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a separate treatment trial. This observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol. Additionally, the investigators will use Compass data with identifiers to pull information on hospitalized control COVID19+ patients from hospital admission date 4/20 to current for comparison.
This protocol is limited to data collection using the EMR to evaluate outcomes following COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and analyzed outside of the expanded access protocol for distribution of COVID19 convalescent plasma. For this protocol, only de-identified, discarded samples may be obtained during routine patient care. Thus, consent will only be obtained from patients/subjects for participation in data abstraction/analysis from the electronic medical record.
- Conditions
- Covid19
- Keywords
- COVID-19, Coronavirus, SARS-CoV-2, convalescent plasma
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID19 Convalescent Plasma Treatment | Hospitalized COVID19 patients who receive COVID19 Convalescent Plasma under Expanded Access protocol NCT04372368. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient Mortality
Overall Inpatient Mortality
Measured: Hospital admission up to Day 28 or discharge
Requirement for mechanical ventilation
Number of patients requiring mechanical ventilation
Measured: Hospital admission up to Day 28 or discharge
Transfer to ICU
Number of patients transferred to an Intensive Care Unit (ICU)
Measured: Hospital admission up to Day 28 or discharge
ICU Mortality
Measured: Hospital admission up to Day 28 or discharge
ICU Length of Stay (LOS)
LOS, measured in days
Measured: Hospital admission up to Day 28 or discharge
Hospital Mortality
Measured: Hospital admission up to Day 28 or discharge
Hospital Length of Stay (LOS)
LOS, measured in days
Measured: Hospital admission up to Day 28 or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start30 Apr 2020
- Primary completion20 Aug 2020
- Study completion20 Aug 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.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John D Beckham, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471051
- Sponsor's protocol ID
- 20-0986
- Status last verified
- Jun 2021
- First submitted
- 13 Jul 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04471051
- Acronym / sponsor ID
- 20-0986
- Conditions
- Covid19
- Keywords
- COVID-19, Coronavirus, SARS-CoV-2, convalescent plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 14 Jul 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 is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Information about patient recovery will be collected from participants' electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with convalescent plasma under a separate expanded access protocol, NCT04372368.
Detailed description
This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a separate treatment trial. This observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol. Additionally, the investigators will use Compass data with identifiers to pull information on hospitalized control COVID19+ patients from hospital admission date 4/20 to current for comparison.
This protocol is limited to data collection using the EMR to evaluate outcomes following COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and analyzed outside of the expanded access protocol for distribution of COVID19 convalescent plasma. For this protocol, only de-identified, discarded samples may be obtained during routine patient care. Thus, consent will only be obtained from patients/subjects for participation in data abstraction/analysis from the electronic medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID19 Convalescent Plasma Treatment | – | –Hospitalized COVID19 patients who receive COVID19 Convalescent Plasma under Expanded Access protocol NCT04372368. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients treated with anti-SARS-CoV-2 convalescent plasma under the Expanded Access protocol NCT04372368. Patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. This observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- Patient treated with COVID19 convalescent plasma.
- Patient or surrogate designated decision maker is willing and able to provide written informed consent.
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.
Primary outcome
Inpatient Mortality
Time frame: Hospital admission up to Day 28 or discharge
Overall Inpatient Mortality
Requirement for mechanical ventilation
Time frame: Hospital admission up to Day 28 or discharge
Number of patients requiring mechanical ventilation
Transfer to ICU
Time frame: Hospital admission up to Day 28 or discharge
Number of patients transferred to an Intensive Care Unit (ICU)
ICU Mortality
Time frame: Hospital admission up to Day 28 or discharge
ICU Length of Stay (LOS)
Time frame: Hospital admission up to Day 28 or discharge
LOS, measured in days
Hospital Mortality
Time frame: Hospital admission up to Day 28 or discharge
Hospital Length of Stay (LOS)
Time frame: Hospital admission up to Day 28 or discharge
LOS, measured in 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 9 Jun 2021.
- 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.
John D Beckham, MD principal investigator
University of Colorado, Denver
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Colorado, Denver at 6 sites 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 4 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 9 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 6 sites 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.
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?
Inpatient Mortality (time frame: Hospital admission up to Day 28 or discharge). The study lists 7 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 9 Jun 2021.