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

• ClinicalTrials.gov Identifier: NCT04364737
• Recruitment Status: Completed
• First Posted: April 28, 2020
• Results First Posted: April 1, 2022
• Last Update Posted: January 26, 2023
• Sponsor: NYU Langone Health
• Collaborators: National Center for Advancing Translational Sciences (NCATS); Albert Einstein College of Medicine; Yale University; The University of Texas Health Science Center, Houston; The University of Texas Health Science Center at Tyler; University of Miami
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19; Coronavirus; Coronavirus Infection	Biological: Convalescent Plasma; Other: Saline solution	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 941 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 17, 2020
• Actual Primary Completion Date: March 29, 2021
• Actual Study Completion Date: December 12, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Convalescent donor plasma	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
Placebo Comparator: Lactated ringer's solution or sterile saline solution	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.

Outcome Measures

Primary Outcome Measures :

1. Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days [ Time Frame: 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 :

1. Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

United States, Florida

University of Miami Hospital and Clinics

Miami, Florida, United States, 33136

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

NYU Langone Health

New York, New York, United States, 10003

United States, Texas

University of Texas Rio Grande Valley

Edinburg, Texas, United States, 78539

The University of Texas Health Science Center

Houston, Texas, United States, 77030

The University of Texas Health Science Center

Tyler, Texas, United States, 75701

United States, Wisconsin

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

Medical College of Wisconsin / Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

NYU Langone Health

National Center for Advancing Translational Sciences (NCATS)

Albert Einstein College of Medicine

Yale University

The University of Texas Health Science Center, Houston

The University of Texas Health Science Center at Tyler

University of Miami

Investigators

• Principal Investigator: Mila B Ortigoza, MD, PhD; NYU Langone Health

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Study Protocol and Statistical Analysis Plan  [PDF] February 11, 2021

Informed Consent Form  [PDF] February 28, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ortigoza MB, Yoon H, Goldfeld KS, Troxel AB, Daily JP, Wu Y, Li Y, Wu D, Cobb GF, Baptiste G, O'Keeffe M, Corpuz MO, Ostrosky-Zeichner L, Amin A, Zacharioudakis IM, Jayaweera DT, Wu Y, Philley JV, Devine MS, Desruisseaux MS, Santin AD, Anjan S, Mathew R, Patel B, Nigo M, Upadhyay R, Kupferman T, Dentino AN, Nanchal R, Merlo CA, Hager DN, Chandran K, Lai JR, Rivera J, Bikash CR, Lasso G, Hilbert TP, Paroder M, Asencio AA, Liu M, Petkova E, Bragat A, Shaker R, McPherson DD, Sacco RL, Keller MJ, Grudzen CR, Hochman JS, Pirofski LA; CONTAIN COVID-19 Consortium for the CONTAIN COVID-19 Study Group; Parameswaran L, Corcoran AT, Rohatgi A, Wronska MW, Wu X, Srinivasan R, Deng FM, Filardo TD, Pendse J, Blaser SB, Whyte O, Gallagher JM, Thomas OE, Ramos D, Sturm-Reganato CL, Fong CC, Daus IM, Payoen AG, Chiofolo JT, Friedman MT, Wu DW, Jacobson JL, Schneider JG, Sarwar UN, Wang HE, Huebinger RM, Dronavalli G, Bai Y, Grimes CZ, Eldin KW, Umana VE, Martin JG, Heath TR, Bello FO, Ransford DL, Laurent-Rolle M, Shenoi SV, Akide-Ndunge OB, Thapa B, Peterson JL, Knauf K, Patel SU, Cheney LL, Tormey CA, Hendrickson JE. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial. JAMA Intern Med. 2022 Feb 1;182(2):115-126. doi: 10.1001/jamainternmed.2021.6850.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04364737
• Other Study ID Numbers: 20-00541
• First Posted: April 28, 2020
• Results First Posted: April 1, 2022
• Last Update Posted: January 26, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD that underlie the results reported in this article, after deidenficiation (text, tables, figures, and appendices) will be shared.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Mila.Ortigoza@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Coronavirus Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases