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

COVID-19 Clinical Trial

Official title:

CONTAIN COVID-19: Convalescent Plasma to Limit Coronavirus Associated Complications: a Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV2 Plasma to Placebo in COVID-19 Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364737
• Other study ID #: 20-00541
• Status: Completed
• Phase: Phase 2
• Start date: April 17, 2020
• Est. completion date: December 12, 2022

Study information

• Verified date: January 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 941
• Est. completion date: December 12, 2022
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Patients =18 years of age

2. Hospitalized with laboratory confirmed COVID-19

3. One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation = 94%, abnormal CXR/CT imaging)

4. Hospitalized for = 72 hours OR within day 3 to 7 days from first signs of illness

5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen

6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis. Exclusion Criteria

1. Receipt of pooled immunoglobulin in past 30 days

2. Contraindication to transfusion or history of prior reactions to transfusion blood products

3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

4. Volume overload secondary to congestive heart failure or renal failure

5. Unlikely to survive past 72 hours from screening based on the assessment of the investigator

6. Unlikely to be able to assess and follow outcome due to poor functional status

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• COVID-19

Intervention

Biological:
• Convalescent Plasma
SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate

Other:
• Saline solution
Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of Texas Rio Grande Valley	Edinburg	Texas
United States	The University of Texas Health Science Center	Houston	Texas
United States	University of Miami Hospital and Clinics	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin / Froedtert Memorial Lutheran Hospital	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

Sponsors (7)

Lead Sponsor	Collaborator
NYU Langone Health	Albert Einstein College of Medicine, National Center for Advancing Translational Sciences (NCATS), The University of Texas Health Science Center at Tyler, The University of Texas Health Science Center, Houston, University of Miami, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days	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	14 days post-randomization
Secondary	Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days	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	28 days post-randomization