Asymptomatic COVID-19 Infection Laboratory-ConfirmedNCT04497779
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
An observational study of Asymptomatic COVID-19 Infection Laboratory-Confirmed and Symptomatic COVID-19 Infection Laboratory-Confirmed, run by City of Hope Medical Center at 1 site in United States.
Trial summary
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
- What is being tested?
- Biospecimen Collection, Diagnostic Laboratory Biomarker Analysis and Electronic Health Record Review
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 29 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with diagnosis of laboratory-confirmed COVID-19 infection
For COVID-19 convalescent individuals:
- Age: ≥ 18 years
- Evidence of COVID-19 documented by a laboratory test either by: a diagnostic test (e.g., a NP swab) at the time of illness OR a positive serological test for SARS-CoV-2 antibodies after recovery, if prior diagnostic testing was not performed at the time COVID-19 was suspected.
Note: If volunteers can't provide evidence of COVID-19, but are otherwise eligible, then we will test them for SARS-CoV-2 antibodies to confirm eligibility.
- Be willing to complete a pre-screening questionnaire
- Be willing to donate blood samples
- Permit medical record review
- For prospective CCP donors only: weigh more than 110 pounds and be in general good health
For (COVID-19 convalescent plasma (CCP) recipients:
- Be enrolled in a clinical trial involving the infusion of CCP for the treatment of COVID-19.
- Be willing to provide blood samples
- Permit medical record review
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish a testing service for screening prospective donors of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP).
II. Characterize the titer and neutralizing properties of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in CCP.
III. Correlate the SARS-CoV-2 antibody characteristics in CCP with the outcome in severely ill COVID-19 patients treated with CCP.
EXPLORATORY OBJECTIVES:
- Facilitate the recruitment of CCP donors in medically underserved areas.
II. Develop high-throughput methods for detection/characterization of SARS-CoV-2 neutralizing and non-neutralizing antibodies.
III. Develop a bank of convalescent plasma that would be available for future studies relating to the content of CCP.
IV. Study the impact of antibody levels, donor characteristics and patient characteristics on outcome in COVID-19 patients treated with CCP.
- Procure blood samples from COVID-19 convalescent volunteers for future COVID-19-related studies.
OUTLINE:
PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.
CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.
CCP RECIPIENTS: Patients undergo collection collection of blood samples at baseline, between CCP unit infusions, 24 hours after last CCP infusion, and between 14-28 after last CCP infusion. Patients' medical records are reviewed.
- Conditions
- Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
- Being tested
- Biospecimen Collection, Diagnostic Laboratory Biomarker Analysis, Electronic Health Record Review, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and/or nasopharyngeal swabs
Diagnostic Laboratory Biomarker AnalysisOther
Correlative studies
Electronic Health Record ReviewOther
Donors and recipients have their medical records reviewed.
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (biospecimen collection, medical record review, CCP) | PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.
CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.
CCP RECIPIENTS: Patients undergo collection of blood samples at baseline, 12-24 hours after each CCP infusion, and 7 days after last CCP infusion. Patients' medical records are reviewed. Receives: Procedure: Biospecimen Collection; Other: Diagnostic Laboratory Biomarker Analysis; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients
Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer.
Measured: Up to 12 months after enrollment
All-cause mortality
Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates.
Measured: At day 28 post-CCP infusion
Donor antibody levels
Will be examined to see how this relates to the duration of hospitalization.
Measured: Up to 28 days post-CCP infusion
Secondary outcomes (2)
Incidence of adverse events
Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R\&D Blueprint Group.
Measured: Up to 28 days post-CCP infusion
CCP recipient outcomes
Will be assessed on a 7-point ordinal scale. The scale is as follows:
- Death;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, requiring low flow supplemental oxygen;
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration);
- Not hospitalized
Measured: Up to 28 days post-CCP infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start13 Jul 2020
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic COVID-19 Infection Laboratory-ConfirmedStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- John Zaia, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497779
- Sponsor's protocol ID
- 20204
- Other IDs
- NCI-2020-04000, 20204, P30CA033572, TGen
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
- ClinicalTrials.gov ID
- NCT04497779
- Acronym / sponsor ID
- 20204
- Conditions
- Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), California Institute for Regenerative Medicine (CIRM)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 4 Aug 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.
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.
Detailed description
PRIMARY OBJECTIVES:
- Establish a testing service for screening prospective donors of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP).
II. Characterize the titer and neutralizing properties of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in CCP.
III. Correlate the SARS-CoV-2 antibody characteristics in CCP with the outcome in severely ill COVID-19 patients treated with CCP.
EXPLORATORY OBJECTIVES:
- Facilitate the recruitment of CCP donors in medically underserved areas.
II. Develop high-throughput methods for detection/characterization of SARS-CoV-2 neutralizing and non-neutralizing antibodies.
III. Develop a bank of convalescent plasma that would be available for future studies relating to the content of CCP.
IV. Study the impact of antibody levels, donor characteristics and patient characteristics on outcome in COVID-19 patients treated with CCP.
- Procure blood samples from COVID-19 convalescent volunteers for future COVID-19-related studies.
OUTLINE:
PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.
CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.
CCP RECIPIENTS: Patients undergo collection collection of blood samples at baseline, between CCP unit infusions, 24 hours after last CCP infusion, and between 14-28 after last CCP infusion. Patients' medical records are reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (biospecimen collection, medical record review, CCP) | – | Procedure: Biospecimen Collection, Other: Diagnostic Laboratory Biomarker Analysis, Other: Electronic Health Record Review, Other: Questionnaire AdministrationPROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed. CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed. CCP RECIPIENTS: Patients undergo collection of blood samples at baseline, 12-24 hours after each CCP infusion, and 7 days after last CCP infusion. Patients' medical records are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of laboratory-confirmed COVID-19 infection
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood and/or nasopharyngeal swabs | Procedure or surgery | Screening (biospecimen collection, medical record review, CCP) |
| Diagnostic Laboratory Biomarker AnalysisCorrelative studies | Other | Screening (biospecimen collection, medical record review, CCP) |
| Electronic Health Record ReviewDonors and recipients have their medical records reviewed. | Other | Screening (biospecimen collection, medical record review, CCP) |
| Questionnaire AdministrationAncillary studies | Other | Screening (biospecimen collection, medical record review, CCP) |
Primary outcome
Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients
Time frame: Up to 12 months after enrollment
Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer.
All-cause mortality
Time frame: At day 28 post-CCP infusion
Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates.
Donor antibody levels
Time frame: Up to 28 days post-CCP infusion
Will be examined to see how this relates to the duration of hospitalization.
2 secondary outcomes
Incidence of adverse events
Time frame: Up to 28 days post-CCP infusion
CCP recipient outcomes
Time frame: Up to 28 days post-CCP infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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 Zaia principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymptomatic COVID-19 Infection Laboratory-Confirmed and Symptomatic COVID-19 Infection Laboratory-Confirmed, run by City of Hope Medical Center 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients (time frame: Up to 12 months after enrollment). The study lists 3 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 30 Oct 2026.