CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients

Phase 2

Completed

• Conditions: Coronavirus Infection; COVID-19; Coronavirus
• Interventions: Biological: Convalescent Plasma; Other: Saline solution

• Registration Number: NCT04364737
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.

Detailed Description

A total of 300 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma (CP) from people who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or a placebo control, Lactated Ringer's Solution (LR) or saline solution (SS). Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the onset of illness OR within 3 days of hospitalization will be eligible to participate.

Study Timeline

• Study Start: 2020-04-17
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Primary Completion: 2021-03-29
• Results First Submitted: 2022-03-28
• Results First Submitted QC: 2022-03-30
• Results First Posted: 2022-04-01
• Study Completion: 2022-12-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 941

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convalescent donor plasma	Convalescent Plasma	-
Lactated ringer's solution or sterile saline solution	Saline solution	-

Primary Outcome Measures

Name	Time	Method
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days	14 days post-randomization	Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed; Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs; Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation \& Mechanical ventilation; pO2/FIO2 \>/= 150 or SpO2/FIO2 \>/=200 8 Mechanical ventilation pO2/FIO2 \< 150 (SpO2/FIO2 \<200) or vasopressors 9 Mechanical ventilation pO2/FIO2 \< 150 and vasopressors, dialysis or ECMO Death 10 Dead

Secondary Outcome Measures

Name	Time	Method
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days	28 days post-randomization	Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed; Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs; Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation \& Mechanical ventilation; pO2/FIO2 \>/= 150 or SpO2/FIO2 \>/=200 8 Mechanical ventilation pO2/FIO2 \< 150 (SpO2/FIO2 \<200) or vasopressors 9 Mechanical ventilation pO2/FIO2 \< 150 and vasopressors, dialysis or ECMO Death 10 Dead

Trial Locations

Locations (8)

Medical College of Wisconsin / Froedtert Memorial Lutheran Hospital; 🇺🇸 Milwaukee, Wisconsin, United States

University of Miami Hospital and Clinics; 🇺🇸 Miami, Florida, United States

Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

The University of Texas Health Science Center; 🇺🇸 Tyler, Texas, United States

University of Texas Rio Grande Valley; 🇺🇸 Edinburg, Texas, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States