COVID-19 Convalescent Plasma

NCT04340050 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB20-0523
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus

Keywords

COVID19

Outcome Measures

Primary Outcomes (2)

• Success of Administering Plasma

  Number of patients who receive convalescent plasma

  At time of administration

• Type of Respiratory Support

  Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

  Until discharge from hospital

Secondary Outcomes (8)

• Cardiac Arrest

  28 days after plasma administration

• Transfer to ICU

  28 days

• ICU Mortality

  Until discharge

• ICU Length of Stay

  Up to 50 days

• Hospital Mortality

  Until discharge

Study Arms (1)

Treatment with anti-SARS-CoV-2 convalescent plasma

EXPERIMENTAL

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours

Biological: anti-SARS-CoV-2 convalescent plasma

Interventions

anti-SARS-CoV-2 convalescent plasma BIOLOGICAL

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours

Treatment with anti-SARS-CoV-2 convalescent plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (4)

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

  PMID: 37162745 DERIVED

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

  PMID: 36734509 DERIVED

• 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.

  PMID: 34013969 DERIVED

• 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.

  PMID: 33044747 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Leila Yazdanbakhsh
• Organization: University of Chicago

leila.yazdanbakhsh@bsd.uchicago.edu

773-834-5087

Study Officials

• Maria Lucia Madariaga, MD

  University of Chicago Biological Sciences Division Department of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: April 10, 2020
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database

Locations

US (1)