Purpose

- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


Donor Eligibility Criteria:

- Age 18-60

- A history of a positive nasopharyngeal swab for COVID-19 or a history of positive
antibody titer test.

- At least 14 days from resolution of COVID-19-associated symptoms including fevers.

- A negative nasopharyngeal swab (or similar test) for COVID-19

- anti-SARS-CoV2 titers >1:500

- Adequate venous access for apheresis

- Meets donor eligibility criteria in accordance to Hackensack University Medical Center
(HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at
the JTCC, and all regulatory agencies as describes in SOP 800 01.

- Required testing of the donor and product must be performed in accordance to FDA
regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)

Recipient Eligibility Criteria:

- Patient age >30 years old, newly diagnosed with a COVID-19 infection with onset of
first symptoms < 96 hours.

- And least one other high-risk feature:

1. Age > 65

2. BMI 30 or above

3. Hypertension, defined as SBP above 140 or DBP above 90, or requiring medication
for control.

4. Coronary artery disease (history, not ECG changes only)

5. Congestive heart failure

6. Peripheral vascular disease (includes aortic aneurysm >= 6 cm)

7. Cerebrovascular disease (history of CVA or TIA)

8. Dementia

9. Chronic pulmonary disease

10. Liver disease (such as portal hypertension, chronic hepatitis)

11. Diabetes (excludes diet-controlled alone)

12. Moderate or severe renal disease defined as having a GFR < 60 mL/min

13. Cancer (exclude if > 5 year in remission)

14. AIDS (not just HIV positive)

Recipient exclusion criteria:

- History of severe transfusion reaction to plasma products

- Need for oxygen supplementation

- Positive test for COVID-19 antibodies

- Chemotherapy-induced neutropenia (ANC < 0.5 x 103/mcL)

- Immunosuppressive medications except for prednisone (or steroid equivalent) > 10 mg
daily.

- Performance status < 50 by KPS

- Pneumonia by radiographic evaluation

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Convalescent Plasma
Fresh or frozen plasma will be infused one time to patients
  • Biological: Convalescent Plasma
    Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
Active Comparator
Best Supportive Care
Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
  • Other: Best Supportive Care
    Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.

Recruiting Locations

More Details

NCT ID
NCT04456413
Status
Terminated
Sponsor
Hackensack Meridian Health

Detailed Description

Overall study design - This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study. A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician. Overall study duration - The study begins when the first subject (donor or recipient) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient). - The expected duration of the study is approximately 12 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.