Clinical trial NCT04388527: COVID-19 Convalescent Plasma for Mechanically Ventilated Population
Official title: An Open-Label, Single Arm, Phase 1, Safety and Exploratory Efficacy Study of Convalescent Plasma for Severely Ill Mechanically Ventilated Participants With COVID-19 Caused by SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid-19
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This open-label, single arm, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women. A total of 50 eligible participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. Participants will receive convalescent plasma on Study Day 1 in addition to standard of care. Participants will be assessed daily while hospitalized and then on Study Days 15, 22, 29, and 60. All participants will undergo a series of safety, efficacy, and laboratory assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.

Eligibility criteria: Inclusion Criteria:

1. Adult ≥18 years of age
2. 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.
3. Hospitalized, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of 7.
4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
5. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements.

Exclusion Criteria:

1. Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
2. Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
3. 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.

Primary outcomes:
measure: Participants With Serious Adverse Events.
timeFrame: Up to Study Day 29
measure: Time to Clinical Improvement.
timeFrame: Up to Study Day 29
Secondary outcomes:
measure: Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration
timeFrame: Up to Study Day 29
measure: Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration
timeFrame: Up to Study Day 29
measure: Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration
timeFrame: From enrollment to Day 29.
measure: Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration
timeFrame: From enrollment to Day 29.
measure: Oxygenation
timeFrame: Daily while hospitalized up to Study Day 29.
measure: Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration.
timeFrame: Daily while in hospital to Study Day 29.
measure: Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.
timeFrame: Daily while in hospital to Study Day 29.
measure: Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.
timeFrame: Daily while in hospital to Study Day 29.
measure: Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days
timeFrame: Daily while in hospital to Study Day 29
measure: Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
timeFrame: From enrollment to Day 29.
measure: Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
timeFrame: From enrollment to Day 29.
measure: Duration of Hospitalization
timeFrame: To Study Day 29
measure: Mortality
timeFrame: 28 days from Study Day 1
measure: Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Study Day 29.
measure: Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Study Day 29
measure: Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29.
measure: Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29.
measure: Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29.
measure: Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29.
measure: Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29.
measure: Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29.
measure: Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29.
measure: Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29
measure: Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration.
timeFrame: Through Day 29
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katharine J. Bar, MD
role: PRINCIPAL_INVESTIGATOR
References: