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

NCT ID: NCT04364737

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 941 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-17
• Study Completion Date: 2022-12-12

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.

Conditions

COVID-19; Coronavirus; Coronavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Convalescent donor plasma

Group Type: ACTIVE_COMPARATOR

Convalescent Plasma

Intervention Type: 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

Lactated ringer's solution or sterile saline solution

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: OTHER

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

Interventions

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

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at Tyler

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mila B Ortigoza, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

University of Miami Hospital and Clinics

Miami, Florida, United States

NYU Langone Health

New York, New York, United States

Montefiore Medical Center

The 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

The University of Texas Health Science Center

Tyler, Texas, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin / Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34901997 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-00541

Identifier Type: -

Identifier Source: org_study_id