Clinical trial NCT04497779: Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Official title: Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asymptomatic COVID-19 Infection Laboratory-Confirmed
Symptomatic COVID-19 Infection Laboratory-Confirmed
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: California Institute for Regenerative Medicine (CIRM)
First posted: 2020-08-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of laboratory-confirmed COVID-19 infection

Brief 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. 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:

I. 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:

I. 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.

V. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients
timeFrame: Up to 12 months after enrollment
measure: All-cause mortality
timeFrame: At day 28 post-CCP infusion
measure: Donor antibody levels
timeFrame: Up to 28 days post-CCP infusion
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 28 days post-CCP infusion
measure: CCP recipient outcomes
timeFrame: Up to 28 days post-CCP infusion
Other outcomes:
measure: Duration of hospitalization (days)
timeFrame: Up to 28 days post-CCP infusion
measure: Time to clinical improvement (days)
timeFrame: Up to 28 days post-CCP infusion
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: John Zaia
role: PRINCIPAL_INVESTIGATOR
References: