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

NCT04364737 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-00541
• Study Type: interventional
• Target: 941
• Locations: 1 country
• Sites: 9

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.

Conditions

COVID-19; Coronavirus; Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days

  28 days post-randomization

Study Arms (2)

Convalescent donor plasma

ACTIVE COMPARATOR

Biological: Convalescent Plasma

Lactated ringer's solution or sterile saline solution

PLACEBO COMPARATOR

Other: Saline solution

Interventions

Convalescent Plasma BIOLOGICAL

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

Convalescent donor plasma

Saline solution OTHER

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

Lactated ringer's solution or sterile saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age
• Hospitalized with laboratory confirmed COVID-19
• One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
• Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
• On supplemental oxygen, non-invasive ventilation or high-flow oxygen
• 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.

You may not qualify if:

• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products
• Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
• Volume overload secondary to congestive heart failure or renal failure
• Unlikely to survive past 72 hours from screening based on the assessment of the investigator
• Unlikely to be able to assess and follow outcome due to poor functional status

Sponsors & Collaborators

• NYU Langone Health: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Albert Einstein College of Medicine: collaborator
• Yale University: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• The University of Texas Health Science Center at Tyler: collaborator
• University of Miami: collaborator

Study Sites (9)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

Location

NYU Langone Health

New York, New York, 10003, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of Texas Rio Grande Valley

Edinburg, Texas, 78539, United States

Location

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center

Tyler, Texas, 75701, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin / Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 34901997 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Mila B. Ortigoza, MD, PhD
• Organization: NYU Langone Health

Mila.Ortigoza@nyulangone.org

646-634-7803

Study Officials

• Mila B Ortigoza, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 28, 2020
• Study Start: April 17, 2020
• Primary Completion: March 29, 2021
• Study Completion: December 12, 2022
• Last Updated: January 26, 2023
• Results First Posted: April 1, 2022

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (9)