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Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467151
Recruitment Status : Withdrawn (Did not obtain funding to proceed with study)
First Posted : July 10, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Kashif Khan, University of Southern California

Brief Summary:
The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).

Condition or disease Intervention/treatment Phase
COVID-19 Drug: anti-SARS-CoV-2 plasma Other: Placebo Phase 2

Detailed Description:

This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients.

After confirmation of COVID-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the 28 days following administration to hospitalized, non-ICU patients. If patient is discharged from the hospital prior to Day 28, Day 28 assessment will be by phone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Anti-SARS-CoV-2 Plasma in Hospitalized Non-ICU Patients With COVID-19
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: anti-SARS-CoV-2 plasma
Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma
Drug: anti-SARS-CoV-2 plasma
Administration of anti-SARS-CoV-2 convalescent plasma
Other Name: Convalescent Plasma

Placebo Comparator: Placebo
Patients receive one dose (250-300ml) of placebo (albumin 5%)
Other: Placebo
Administration of placebo (albumin 5%)
Other Name: Albumin




Primary Outcome Measures :
  1. Disease progression measured by WHO scale [ Time Frame: Day 0 through Day 28 (or hospital discharge) ]
    Disease progression from the state at randomization (with a "3" or "4" on the WHO Ordinal Scale for Clinical Improvement) to requiring invasive mechanical ventilation (which is "6" or greater on the WHO scale) during the study period


Secondary Outcome Measures :
  1. Comparison of maximum WHO score per group [ Time Frame: Day 0 through Day 28 (or hospital discharge) ]
    Comparison of the number of participants reaching a maximum daily WHO score of 5, 7, and 8 during the study period per group

  2. Comparison of decrease of median and maximum WHO score per group [ Time Frame: Day 0 through Day 28 (or hospital discharge) ]
    Comparison of the median and maximum daily WHO scores during the study period per group

  3. Comparison of time to clinical improvement per group [ Time Frame: Day 0 through Day 28 (or hospital discharge) ]
    Comparison of time to clinical improvement, defined as time between randomization and time to improvement (WHO Ordinal Scale "2" first reached for at least 1 day)

  4. Comparison of time to reach score of "6" or greater on the WHO scale [ Time Frame: Day 0 through Day 28 (or hospital discharge) ]
    Evaluate the time to reach score of at least 6 within 28 days


Other Outcome Measures:
  1. Comparison of hospital length of stay per group [ Time Frame: Day 0 through Day 28 (or hospital discharge) ]
    Evaluate number of days hospitalized

  2. Comparison of ICU length of stay per group [ Time Frame: Day 0 through Day 28 (or hospital discharge) ]
    Evaluate number of hours in the ICU



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 ≥18 years of age
  • Hospitalized with COVID-19-related acute respiratory symptoms
  • Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3 ("Hospitalized, no oxygen therapy) or 4 ("Hospitalized, on oxygen by mask or nasal prongs")
  • Laboratory-confirmed COVID-19
  • First signs of infection occurring no more than 14 days prior to enrollment

Exclusion Criteria:

  • Receipt of pooled immunoglobulin in the past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products
  • Admission to intensive care unit at any point during hospital course prior to enrollment

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): NCT04467151


Sponsors and Collaborators
Kashif Khan
Investigators
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Principal Investigator: Kashif T Khan, MD, SM Keck School of Medicine of University of Southern California
Publications:

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Responsible Party: Kashif Khan, Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT04467151    
Other Study ID Numbers: HS-20-00516
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kashif Khan, University of Southern California:
Anti-SARS-CoV-2 plasma