Clinical trial NCT04502472: Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma
Official title: Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma Collected From Individuals With Documented Infection and Recovery From COVID-19 (SARS-CoV-2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Covid-19
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 will be recruitment and enrollment of plasma donors. Phase 2 will be continued recruitment and enrollment of plasma donors, with the addition of recruitment and enrollment of plasma recipients.
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.

Detailed description: The purpose of this research study is to see if convalescent plasma is safe and effective for the treatment of patients acutely ill with COVID-19. The researchers want to confirm the right dose levels of immunoglobulins/antibodies (immune proteins) and find out what therapeutic effects plasma donated by recovered individuals has on people severely sick with COVID-19.

Eligibility criteria: Phase 1 Inclusion Criteria:

Inclusion Criteria for Convalescent Plasma Donors:

- Outpatients 18 years old and older who have recovered from COVID-19:

* Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result
* Complete resolution of symptoms at least 14 days prior to donation
* Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit
* Able to meet standard criteria for blood donation
* Clinically stable based on provider assessment

Phase 1 Exclusion Criteria:

Exclusion criteria:

* Inability to complete or contraindication to donation based on Donor History -
* Questionnaire (DHQ), FDA approved standard blood donation form
* Hb\<13.0 g/dL for males
* Hb\<12.5 g/dL for females
* History of 3 more pregnancies unless HLA antibody testing is performed and deemed acceptable by director of blood donor services (to reduce risks of transfusion Related Acute Lung Injury in recipients). The presence of any transfusion transmitted diseases is based on history or test results from blood sample collected from the donor at time of plasma collection in accordance to standard practice.
* Female subjects who are pregnant by self-report.
* Receipt of pooled immunoglobulin in past 30 days

PHASE 2: Inclusion Criteria for Recipients of COVID-19 Convalescent Plasma:

* Patients in the Inova Health System with confirmed COVID-19 by PCR testing
* Age ≥ 13 years
* Currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome as follows:
* Severe COVID-19: (three or more of the following)

  * Dyspnea
  * Respiratory rate ≥ 30/min
  * Blood oxygen saturation (SpO2) ≤ 94% on room air
  * Partial pressure of arterial oxygen to fraction of inspired oxygen (P:F) ratio \< 300
  * Pulmonary infiltrates \> 50% of lung parenchyma within 24 to 48 hours
* Life-threatening disease is defined as: (one of the following)

  * Respiratory failure
  * Septic shock, and/or
  * Multiple organ dysfunction or failure
* Patient must provide informed consent or have health care power of attorney/next of kin provide consent if he/she cannot.

PHASE 2 Exclusion Criteria:

* Contraindication to receive plasma as deemed by the treating physician
* Severe hypercoagulable state (documented in medical chart or by treating physician assessment)
* Absolute IgA deficiency
* Prior history of Transfusion Related Acute Lung Injury (TRALI)
* Inability to tolerate plasma volume due to severe systolic or diastolic heart failure despite slower infusion and diuretic administration
* Positive pregnancy test (HCG)

Primary outcomes:
measure: Change is Clinical Status
timeFrame: Time of plasma infusion (day 0) compared to day 7
measure: Transfusion Related Events Due to Administration of CCP
timeFrame: Within 6 hours of infusion
Secondary outcomes:
measure: Change is Clinical Status
timeFrame: Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28
measure: Length of Hospital Stay
timeFrame: Total Index Hospitalization
measure: Mechanical Ventilation
timeFrame: Days 7, 14, 21, 28
measure: Change in Mechanical Ventilation Status
timeFrame: Day 0 (date of CCP transfusion) to Day 28
measure: Mortality
timeFrame: From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Anne Brown, M.D.
role: PRINCIPAL_INVESTIGATOR
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