Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection

NCT04513158 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-N0124
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

Brief Summary

This study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.

Conditions

Covid19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Determine the Therapeutic Efficacy (Response Rate) of Convalescent Plasma Infusion in Patients at High Risk for Mortality When Infected by SARS-CoV-2 (COVID-19).

  Measured by respiratory rate \>30/min, blood oxygen saturation \<93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300 and received a medical diagnosis of respiratory failure, septic shock or multiple

  Through study completion, an average of 30 days

Secondary Outcomes (7)

• Determine the Immunologic Effects of Convalescent Plasma Infusion

  Through study completion, an average of 14 days

• Absolute Lymphocyte Count (10*3/uL)

  Through study completion, an average of 14 days

• Reatinine Kinase (mg/dL)

  Through study completion, an average of 14 days

• C-reactive Protein (mg/dl)

  Through study completion, an average of 14 days

• D-Dimer (ng/ml FEU)

  Through study completion, an average of 14 days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Study is single arm all patients hospitalized meeting inclusion/exclusion criteria and providing informed consent to receive one unit (approximately 200 mL) of convalescent plasma with data collected daily on routine (non-research) clinical assessments/physical exams and lab results.

Biological: Convalescent Plasma

Interventions

Convalescent Plasma BIOLOGICAL

Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SARS-CoV-2 infection via RT-PCR or FDA approved testing.
• Patients must also have the following indications for enrollment:
• i. D-Dimer \> 500 ng/ml FEU OR
• ii. IL-6\> 5 pg/mL
• With any of the following:
• iii. Lymphocytes \< 0.8 103/ul OR
• iv. LDH \> 700 U/L OR
• v. CK \> 170 U/L OR
• vi. CRP \> 1.0 mg/dl OR
• vii. Ferritin \> 1000 ng/ml
• AND one of the following:
• viii. Age over 60 years
• ix. Underlying Active Malignancy
• x. Cardiovascular Disease
• xi. Active Tobacco Use

You may not qualify if:

• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to previous transfusion history.
• Respiratory rate \>30/min
• Blood oxygen saturation \<93%
• Partial pressure of arterial oxygen to fraction of inspired oxygen ration \<300
• Diagnosis of respiratory failure, septic shock or multiple organ dysfunction/failure

Sponsors & Collaborators

• Joseph M. Flynn, D.O., MPH: lead

Study Sites (4)

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Norton Women's and Children's Hospital

Louisville, Kentucky, 40207, United States

Location

Norton Audubon Hospital

Louisville, Kentucky, 40217, United States

Location

Norton Brownsboro Hospital

Louisville, Kentucky, 40241, United States

Location

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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

Limitations and Caveats

Data was not collected or analyzed. Trial was stopped early because other therapy options became more readily available and the majority of room air patients were being discharged from the ED making finding eligible patients more difficult.

Results Point of Contact

• Title: Joseph M. Flynn, DO, MPH
• Organization: Norton Healthcare

joseph.flynn@nortonhealthcare.org

502-272-5001

Study Officials

• Joseph M Flynn, DO, MPH

  Norton Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All hospitalized patients meeting study inclusion/exclusion criteria and providing informed consent for participation in the study will receive one unit (approximately 200 mL) of convalescent plasma over one hour to with data collection of routine physical exams/clinical assessments (daily) and routine lab results (every 3 days).

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 14, 2020
• Study Start: August 14, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)