Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19

NCT04358211 | Unknown

• 1 other identifier: 2020-595
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in

1. 1.intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT.
2. 2.hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19.
3. 3.Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older.
4. 4.Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness.

Conditions

COVID-19

Interventions

Biological: COVID-19 convalescent plasma BIOLOGICAL

One unit of ABO compatible COVID-19 convalescent plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Population 1: Associated Severe Pulmonary Complications
• years or older.
• Hospitalized and intubated in the ICU with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements, or requirement for informed consent is WAIVED due to the inability to communicate with the patient and unable to identify legally authorized representative.
• Consents to storage of specimens for future testing, or consent waived.
• The requirements to waive a consent are delineated in 21 CFR 50.23 and will be followed.
• Pregnant and breastfeeding women will not be excluded from the study.
• Population 2: Coronavirus Associated Complications in hospitalized patients
• Patients must be 18 years of age or older.
• Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
• Patient agrees to storage of specimens for future testing.

You may not qualify if:

• Population 1:
• Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
• Severe multi-organ failure with expected life expectancy \< 24h as determined by the treating physician.
• Population 2:
• Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
• Receipt of pooled immunoglobulin in past 30 days.
• Contraindication to transfusion or history of prior reactions to transfusion blood products.

Sponsors & Collaborators

• Nakhle Saba, MD: lead

Study Sites (1)

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (4)

• van Erp EA, Luytjes W, Ferwerda G, van Kasteren PB. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus Infection and Disease. Front Immunol. 2019 Mar 22;10:548. doi: 10.3389/fimmu.2019.00548. eCollection 2019.

  PMID: 30967872 RESULT

• Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.

  PMID: 31826992 RESULT

• Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.

  PMID: 15616839 RESULT

• Huang Z, Ning B, Yang HS, Youngquist BM, Niu A, Lyon CJ, Beddingfield BJ, Fears AC, Monk CH, Murrell AE, Bilton SJ, Linhuber JP, Norton EB, Dietrich ML, Yee J, Lai W, Scott JW, Yin XM, Rappaport J, Robinson JE, Saba NS, Roy CJ, Zwezdaryk KJ, Zhao Z, Hu TY. Sensitive tracking of circulating viral RNA through all stages of SARS-CoV-2 infection. J Clin Invest. 2021 Apr 1;131(7):e146031. doi: 10.1172/JCI146031.

  PMID: 33561010 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

US (1)