COVID-19 Convalescent Plasma for Mechanically Ventilated Population

NCT04388527 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 842996 (PennCCP-01)
• Study Type: interventional
• Target: 32
• 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 can improve patients' health when they are sick with COVID-19.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (2)

• Participants With Serious Adverse Events.

  Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.

  Up to Study Day 29

• Time to Clinical Improvement.

  Time to removal from mechanical ventilation.

  Up to Study Day 29

Secondary Outcomes (24)

• Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration

  Up to Study Day 29

• Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration

  Up to Study Day 29

• Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration

  From enrollment to Day 29.

• Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration

  From enrollment to Day 29.

• Oxygenation

  Daily while hospitalized up to Study Day 29.

Study Arms (1)

Treatment

EXPERIMENTAL

Penn COVID-19 convalescent plasma

Biological: COVID-19 Convalescent Plasma

Interventions

COVID-19 Convalescent Plasma BIOLOGICAL

Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.

Treatment

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, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of 7.
• Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
• 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. a. 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

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, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 14, 2020
• Study Start: April 30, 2020
• Primary Completion: January 25, 2021
• Study Completion: January 30, 2021
• Last Updated: April 4, 2022
• Results First Posted: April 4, 2022

Record last verified: 2022-03

Locations

US (1)