COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.

NCT04397757 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 843003 (PennCCP-02)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.

Conditions

COVID-19

Keywords

Convalescent plasma

Outcome Measures

Primary Outcomes (2)

• Participants With Serious Adverse Events.

  Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.

  Up to Study Day 29

• Clinical Severity Score

  Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome. Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death

  Up to Study Day 29

Secondary Outcomes (24)

• Clinical Status Assessment, Time to Recovery

  Up to Study Day 29

• National Early Warning Score (NEWS) Clinical Status Assessment

  Up to Study Day 29

• Oxygenation

  Daily while hospitalized and up to Study Day 29

• Incidence of New Oxygenation Use up to Day 29

  From enrollment to Day 29.

• Duration of New Oxygen Use up to Day 29

  From enrollment to Day 29.

Study Arms (2)

COVID-19 Convalescent plasma

EXPERIMENTAL

COVID-19 Convalescent plasma on Study Day 1 in addition to standard care

Biological: COVID-19 Convalescent Plasma

Standard care

NO INTERVENTION

Standard care alone

Interventions

COVID-19 Convalescent Plasma BIOLOGICAL

2 units of COVID-19 convalescent plasma compatible with their blood type

COVID-19 Convalescent plasma

Eligibility Criteria

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

You may qualify if:

• Adult ≥18 years of age
• Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment.
• Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.
• Hospitalized in participating facility.
• Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
• Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:
• Room air saturation of oxygen (SaO2) \< 93%, OR
• Requiring supplemental oxygen, OR
• Tachypnea with respiratory rate ≥30
• Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements

You may not qualify if:

• Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
• Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
• Receipt of other investigational therapy as a part of another clinical trial. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Herman JD, Wang C, Burke JS, Zur Y, Compere H, Kang J, Macvicar R, Taylor S, Shin S, Frank I, Siegel D, Tebas P, Choi GH, Shaw PA, Yoon H, Pirofski LA, Julg BD, Bar KJ, Lauffenburger D, Alter G. Nucleocapsid-specific antibody function is associated with therapeutic benefits from COVID-19 convalescent plasma therapy. Cell Rep Med. 2022 Nov 15;3(11):100811. doi: 10.1016/j.xcrm.2022.100811. Epub 2022 Oct 24.

  PMID: 36351430 DERIVED

• Bar KJ, Shaw PA, Choi GH, Aqui N, Fesnak A, Yang JB, Soto-Calderon H, Grajales L, Starr J, Andronov M, Mastellone M, Amonu C, Feret G, DeMarshall M, Buchanan M, Caturla M, Gordon J, Wanicur A, Monroy MA, Mampe F, Lindemuth E, Gouma S, Mullin AM, Barilla H, Pronina A, Irwin L, Thomas R, Eichinger RA, Demuth F, Luning Prak ET, Pascual JL, Short WR, Elovitz MA, Baron J, Meyer NJ, Degnan KO, Frank I, Hensley SE, Siegel DL, Tebas P. A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia. J Clin Invest. 2021 Dec 15;131(24):e155114. doi: 10.1172/JCI155114.

  PMID: 34788233 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Regulatory Lead
• Organization: University of Pennsylvania

psom-ind-ide@pobox.upenn.edu

512-662-4484

Study Officials

• Katharine J. Bar

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to receive either convalescent plasma on Study Day 1 in addition to standard care or standard care alone.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 21, 2020
• Study Start: May 13, 2020
• Primary Completion: February 6, 2021
• Study Completion: March 8, 2021
• Last Updated: April 19, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-03

Locations

US (1)