Clinical trial NCT04340050: COVID-19 Convalescent Plasma
Official title: Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Coronavirus
Keywords: COVID19
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.

Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.

Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.

Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.


Eligibility criteria: Donor Inclusion Criteria:

* Age greater or equal to 18
* Able to donate blood per blood bank standard guidelines
* Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
* Complete resolution of symptoms at least 28 days prior to donation
* Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors

Donor Exclusion Criteria:

* Does not provide consent
* Does not meet standard blood bank donation guidelines
* Unsuccessful blood donation

Recipient Inclusion Criteria:

* Patients must be 18 years of age or older
* Must have laboratory-confirmed COVID-19
* Must have severe or immediately life-threatening COVID-19

  * Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or lung infiltrates \> 50% within 24 to 48 hours
  * Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
* Must be less than 21 days from the start of illness
* Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
* Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
* Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma

Recipient Exclusion Criteria:

* 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
* Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma

Primary outcomes:
measure: Success of Administering Plasma
timeFrame: At time of administration
measure: Type of Respiratory Support
timeFrame: Until discharge from hospital
Secondary outcomes:
measure: Cardiac Arrest
timeFrame: 28 days after plasma administration
measure: Transfer to ICU
timeFrame: 28 days
measure: ICU Mortality
timeFrame: Until discharge
measure: ICU Length of Stay
timeFrame: Up to 50 days
measure: Hospital Mortality
timeFrame: Until discharge
measure: Hospital Length of Stay
timeFrame: Until discharge
measure: Ventilator-free Days
timeFrame: 28 days
measure: Overall Survival (28-day Mortality)
timeFrame: 28 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago Biological Sciences Division Department of Surgery
name: Maria Lucia Madariaga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
citation: Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.