COVID-19Phase 2CAPRINCT04421404
Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients
A Phase 2 study testing COVID-19 Convalescent Plasma (CCP) in people with COVID-19 and Sars-CoV2, run by Priscilla Hsue, MD at 3 sites in United States.
Trial summary
The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- COVID-19 Convalescent Plasma (CCP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jun 2020to 30 Apr 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
- Patients ≥18 years of age
- Hospitalized with COVID-19
- Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
- Pulmonary infiltrates on chest imaging
- Oxygenation of <95% on room air
- Laboratory confirmed COVID-19
Who cannot join
- Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
- Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
- Currently experiencing severe hypoxemic failure, as defined in study endpoints
- Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
- Not currently enrolled another interventional clinical trial of COVID-19 treatment.
- Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19 treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these medications must be stopped prior to enrollment. Receipt of current standard of care COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be recorded as a concomitant medication.
- Note: Pregnancy is not exclusionary but will merit additional discussion of risks \& benefits in the context of ongoing pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
San Francisco General Hospital
San Francisco, California, 94110
UCSF Medical Center at Mount Zion
San Francisco, California, 94115
University of California, San Francisco Medical Center (Parnassus Campus)
San Francisco, California, 94143
About this study
Official title: A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients
The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.
Read the detailed description
A total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.
- Being tested
- COVID-19 Convalescent Plasma (CCP), Placebo
- Keywords
- COVID-19, Sars-CoV2, 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.
COVID-19 Convalescent Plasma (CCP)Biological
COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
PlaceboBiological
Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Convalescent Plasma | Experimental | Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization. Receives: Biological: COVID-19 Convalescent Plasma (CCP) |
| Placebo | Placebo comparator | Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Ventilation or Death Endpoint
Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.
Measured: Day 14
Secondary outcomes (2)
Mechanical Ventilation or Death Endpoint
Progression to mechanical ventilation or death within the first 28 days of enrollment.
Measured: Day 28
8-Point Ordinal Scale Endpoint
Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale.
8 Point WHO Ordinal Scale of Clinical Status:
Uninfected (No clinical or virological evidence of infection) - 0
Ambulatory (No limitation of activities) - 1 Ambulatory (Limitation of Activities) - 2
Hospitalized Mild Disease (Hospitalized, no oxygen therapy) - 3 Hospitalized Mild Disease (Oxygen by mask or nasal prongs) - 4
Hospitalized Severe Disease (Non-invasive ventilation or high flow oxygen) - 5 Hospitalized Severe Disease (Intubation and mechanical ventilation) - 6 Hospitalized Severe Disease (Ventilation + Additional organ support (pressors, RRT, ECMO)) - 7
Dead (Death) - 8
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start9 Jun 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects enrolled in the study will be randomized using a web based randomization procedure to receive convalescent plasma versus non-immune plasma at a 1:1 ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Priscilla Hsue, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Vitalant Research Institute, San Francisco General Hospital
- Responsible party
- Sponsor-investigator, Priscilla Hsue, MD, University of California, San Francisco
- Investigators
- Priscilla Hsue, MD, Principal investigator, University of California, San FranciscoAnnie Leutkemeyer, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421404
- Sponsor's protocol ID
- 20-30794
- Acronym
- CAPRI
- Status last verified
- Oct 2022
- First submitted
- 3 Jun 2020
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04421404
- Acronym / sponsor ID
- CAPRI / 20-30794
- Keywords
- COVID-19, Sars-CoV2, Convalescent plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Priscilla Hsue, MDUniversity, hospital or other
- Collaborators
- Vitalant Research Institute, San Francisco General Hospital
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 25 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.
Detailed description
A total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects enrolled in the study will be randomized using a web based randomization procedure to receive convalescent plasma versus non-immune plasma at a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Convalescent Plasma | Experimental | Biological: COVID-19 Convalescent Plasma (CCP)Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization. |
| Placebo | Placebo comparator | Biological: PlaceboSubjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥18 years of age
- Hospitalized with COVID-19
- Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
- Pulmonary infiltrates on chest imaging
- Oxygenation of <95% on room air
Key exclusion criteria (7 listed)
- Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
- Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
- Currently experiencing severe hypoxemic failure, as defined in study endpoints
- Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
- Not currently enrolled another interventional clinical trial of COVID-19 treatment.
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 |
|---|---|---|
| COVID-19 Convalescent Plasma (CCP)COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined. | Biological | COVID-19 Convalescent Plasma |
| PlaceboStandard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2. | Biological | Placebo |
Primary outcome
Mechanical Ventilation or Death Endpoint
Time frame: Day 14
Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.
2 secondary outcomes
Mechanical Ventilation or Death Endpoint
Time frame: Day 28
8-Point Ordinal Scale Endpoint
Time frame: Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- 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.
Priscilla Hsue, MD principal investigator
University of California, San Francisco
Annie Leutkemeyer, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVID-19 Convalescent Plasma (CCP) in people with COVID-19 and Sars-CoV2, run by Priscilla Hsue, MD at 3 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 6 inclusion and 7 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 25 Aug 2021). 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?
Mechanical Ventilation or Death Endpoint (time frame: Day 14). 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 7 Oct 2022.