Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

NCT04434131 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-227
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection

  Neutralizing antibody titer (PRNT 80)

  Day of convalescent plasma infusion (day 0) and following day (day 1)

Secondary Outcomes (2)

• Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score

  Within 4 hours of transfusion

• Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples

  Day 0,1,3,7 and 14

Study Arms (1)

Convalescent Plasma

EXPERIMENTAL

The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.

Drug: Convalescent Plasma

Interventions

Convalescent Plasma DRUG

Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.

Also known as: Not appicable

Convalescent Plasma

Eligibility Criteria

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

You may qualify if:

• 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. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
• Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
• For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.

You may not qualify if:

• Female subjects with positive pregnancy test or breastfeeding.
• Receipt of pooled immunoglobulin in past 30 days.
• Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
• On ECMO or in refractory shock at entry

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (5)

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

  PMID: 37162745 DERIVED

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

  PMID: 36734509 DERIVED

• Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

  PMID: 34013969 DERIVED

• Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

  PMID: 33044747 DERIVED

• Bradfute SB, Hurwitz I, Yingling AV, Ye C, Cheng Q, Noonan TP, Raval JS, Sosa NR, Mertz GJ, Perkins DJ, Harkins MS. Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibody Titers in Convalescent Plasma and Recipients in New Mexico: An Open Treatment Study in Patients With Coronavirus Disease 2019. J Infect Dis. 2020 Oct 13;222(10):1620-1628. doi: 10.1093/infdis/jiaa505.

  PMID: 32779705 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

Results Point of Contact

• Title: Dr. Michelle Harkins
• Organization: University of New Mexico Health Sciences Center

mharkins@salud.unm.edu

5052724751

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pulmonary/ Critical Care/Sleep Medicine

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: April 28, 2020
• Primary Completion: July 31, 2020
• Study Completion: March 12, 2021
• Last Updated: March 8, 2023
• Results First Posted: March 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)