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

Phase 2

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: anti-SARS-CoV-2 plasma; Other: Placebo

• Registration Number: NCT04467151
• Lead Sponsor: Kashif Khan

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.

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Status Verified: 2020-10
• Study Start: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-SARS-CoV-2 plasma	anti-SARS-CoV-2 plasma	Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma
Placebo	Placebo	Patients receive one dose (250-300ml) of placebo (albumin 5%)

Primary Outcome Measures

Name	Time	Method
Disease progression measured by WHO scale	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

Name	Time	Method
Comparison of decrease of median and maximum WHO score per group	Day 0 through Day 28 (or hospital discharge)	Comparison of the median and maximum daily WHO scores during the study period per group
Comparison of maximum WHO score per group	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
Comparison of time to clinical improvement per group	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)
Comparison of time to reach score of "6" or greater on the WHO scale	Day 0 through Day 28 (or hospital discharge)	Evaluate the time to reach score of at least 6 within 28 days