Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19

Kashif Khan

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19

Treatments: Other: Placebo; Drug: anti-SARS-CoV-2 plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04467151

HS-20-00516

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

anti-SARS-CoV-2 plasma

Experimental group

Description:

Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma

Treatment:

Drug: anti-SARS-CoV-2 plasma

Placebo

Placebo Comparator group

Description:

Patients receive one dose (250-300ml) of placebo (albumin 5%)

Treatment:

Other: Placebo