Clinical trial NCT04354831: Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients
Official title: An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Froedtert Hospital
First posted: 2020-04-21
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
Primary purpose: TREATMENT

Brief summary: This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

Detailed description: This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years or older
2. Hospitalized as an in-patient with positive COVID-19 test by PCR
3. Presence of respiratory symptoms with any of severe features as below:

   * Respiratory Rate ≥ 24/min
   * Oxygen Support \>3L/min by nasal cannula
   * New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
4. Patient / HCPOA must agree to storage of blood specimens for future testing.
5. Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
6. Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.

Exclusion Criteria:

1. FCBP with positive pregnancy test (mandatory)
2. Breastfeeding females
3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
4. Mechanical ventilation for \> 14 days
5. Days from symptom onset \>21 days
6. Expected survival \< 72 hours
7. Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
8. Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .

Primary outcomes:
measure: Overall Mortality
timeFrame: Duration of patient hospitalization, sometimes exceeding 60 days
Secondary outcomes:
measure: Length of Admission After Plasma Infusion
timeFrame: Length of admission for COVID through study follow-up period
measure: Length of ICU Stay After Convalescent Plasma Infusion
timeFrame: Length of admission in the ICU for COVID through study follow-up period
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Mary Beth Graham
role: PRINCIPAL_INVESTIGATOR
References: