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Convalescent Plasma vs. Placebo in Emergency Room Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355767
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:

This study will evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma (convalescent plasma) versus control (standard plasma) in patients with COVID-19 respiratory symptoms.

This study will recruit patients who present for clinical evaluation in the emergency department (ED) but who do not require hospital admission. Disease progression due to COVID-19 will be assessed, which may include changes in symptom severity, return visit to the ED, or hospital admission.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: Convalescent Plasma Biological: Standard Plasma Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Convalescent Plasma to Limit Coronavirus Associated Complications: A Randomized Double-Blind, Phase 2 Study Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Placebo in Emergency Room Patients
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Convalescent Plasma
Participants will receive convalescent plasma as part of clinical care for COVID-19 disease,
Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma (1-2 units; ~200-600 mL at antibody titer >1:80).

Experimental: Standard Plasma
Participants will receive standard plasma as part of clinical care for COVID-19 disease,
Biological: Standard Plasma
Standard plasma collected prior to 31 December 2019 or that is negative for anti- SARS-CoV-2 antibodies.




Primary Outcome Measures :
  1. Time to disease progression [ Time Frame: 15 days ]

    Progression of disease is defined as any of the following:

    • Patient admitted to the hospital
    • Patient seen in the emergency room (return visit after visit when enrollment takes place)
    • Patient reports increased symptoms of 2 levels on the COVID Outpatient Ordinal Outcomes Scale over a 24 hour period
    • Patient reports increased symptoms of 1 level on the COVID Outpatient Ordinal Outcomes Scale observed for a 48 hour period.

    COVID Outpatient Ordinal Outcomes Scale:

    1. Patient requires care in the hospital
    2. Patient requires care in the ED or urgent care
    3. Patient at home with symptoms rates as moderate (defined as fever, shortness of breath, abdominal pain)
    4. Patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness of breath)
    5. Patient in their usual state of health


Secondary Outcome Measures :
  1. Change in symptom severity over time [ Time Frame: 15 days ]

    Categorical change in symptom severity rated on the COVID Outpatient Ordinal Outcomes Scale:

    1. Patient requires care in the hospital
    2. Patient requires care in the ED or urgent care
    3. Patient at home with symptoms rates as moderate (defined as fever, shortness of breath, abdominal pain)
    4. Patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness of breath)
    5. Patient in their usual state of health



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring clinical evaluation in the emergency department (ED) but who do not require hospital admission.
  • Patients who are within 14 days since the onset of COVID-19 symptoms and are confirmed to have the disease via COVID-19 SARS-CoV-2 RT-PCR testing or rapid RNA assay.
  • Patient agrees to storage of specimens for future testing.

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Received pooled immunoglobulin in the past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355767


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Contact: Study Team    650-724-7186    jcunning@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kevin Schulman, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04355767    
Other Study ID Numbers: 56249
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data (IPD).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes