Clinical trial NCT04467151: Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Anti-SARS-CoV-2 Plasma in Hospitalized Non-ICU Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Keywords: Anti-SARS-CoV-2 plasma
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Disease progression measured by WHO scale
timeFrame: Day 0 through Day 28 (or hospital discharge)
Secondary outcomes:
measure: Comparison of maximum WHO score per group
timeFrame: Day 0 through Day 28 (or hospital discharge)
measure: Comparison of decrease of median and maximum WHO score per group
timeFrame: Day 0 through Day 28 (or hospital discharge)
measure: Comparison of time to clinical improvement per group
timeFrame: Day 0 through Day 28 (or hospital discharge)
measure: Comparison of time to reach score of "6" or greater on the WHO scale
timeFrame: Day 0 through Day 28 (or hospital discharge)
Other outcomes:
measure: Comparison of hospital length of stay per group
timeFrame: Day 0 through Day 28 (or hospital discharge)
measure: Comparison of ICU length of stay per group
timeFrame: Day 0 through Day 28 (or hospital discharge)
Locations:
Study officials:
affiliation: Keck School of Medicine of University of Southern California
name: Kashif T Khan, MD, SM
role: PRINCIPAL_INVESTIGATOR
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