CoronavirusPhase 2NCT04325672
Convalescent Plasma to Limit Coronavirus Associated Complications
A Phase 2 study testing Convalescent Plasma in people with Coronavirus, run by Mayo Clinic.
Trial summary
Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 31 Dec 2022
- 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
- Patients must be 18 years of age or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
- Patient agrees to storage of specimens for future testing.
Who cannot join
- 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
About this study
Official title: Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
Read the detailed description
High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.
- Conditions
- Coronavirus
- Being tested
- Convalescent Plasma
- Keywords
- 2019 novel Coronavirus, SARS-CoV-2, COVID-19
- 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.
Convalescent PlasmaBiological
Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma Group | Experimental | Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64. Receives: Biological: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA in SARS-CoV-2
Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
Measured: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
ICU Admissions
Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Measured: 90 days after transfusion
Hospital Mortality
Total number of subject deaths.
Measured: 90 days after transfusion
Hospital Length of Stay (LOS)
The total number of days subjects were admitted to the hospital.
Measured: 90 days after transfusion
Secondary outcomes (2)
Type of respiratory support
The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
Measured: 90 days after transfusion or until hospital discharge (whichever comes first)
Duration of respiratory support
The total number of days subjects required respiratory support.
Measured: 90 days after transfusion or until hospital discharge (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Study stopped due to opening Expanded Access Protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Joyner, M.D., Mayo Clinic
- Investigators
- Michael Joyner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325672
- Sponsor's protocol ID
- 20-002864
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04325672
- Acronym / sponsor ID
- 20-002864
- Conditions
- Coronavirus
- Keywords
- 2019 novel Coronavirus, SARS-CoV-2, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to opening Expanded Access Protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Mar 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.
Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
Detailed description
High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent Plasma Group | Experimental | Biological: Convalescent PlasmaSubjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be 18 years of age or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
- Patient agrees to storage of specimens for future testing.
Key exclusion criteria (3 listed)
- 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
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 PlasmaAnti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64. | Biological | Convalescent Plasma Group |
Primary outcome
RNA in SARS-CoV-2
Time frame: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
ICU Admissions
Time frame: 90 days after transfusion
Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Hospital Mortality
Time frame: 90 days after transfusion
Total number of subject deaths.
Hospital Length of Stay (LOS)
Time frame: 90 days after transfusion
The total number of days subjects were admitted to the hospital.
2 secondary outcomes
Type of respiratory support
Time frame: 90 days after transfusion or until hospital discharge (whichever comes first)
Duration of respiratory support
Time frame: 90 days after transfusion or until hospital discharge (whichever comes first)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Michael Joyner, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent Plasma in people with Coronavirus, run by Mayo Clinic.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
RNA in SARS-CoV-2 (time frame: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion). The study lists 4 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 8 Apr 2020.