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Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04456413
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : March 1, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Hackensack Meridian Health

Study Description
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Brief Summary:
  • 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 or disease Intervention/treatment Phase
COVID-19 Biological: Convalescent Plasma Other: Best Supportive Care Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization Rate [ Time Frame: 10 Days ]
    The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.


Secondary Outcome Measures :
  1. Time to symptoms resolution [ Time Frame: 2 Months ]
    The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.

  2. Overall survival [ Time Frame: 2 Months ]
    Overall survival (OS) will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.

  3. Rate of virologic clearance by nasopharyngeal swab at 2 and 4 weeks [ Time Frame: 2 and 4 Weeks ]
  4. Rate of nasopharyngeal swab positivity in donors [ Time Frame: 2 Months ]
  5. Rate of donor titers level [ Time Frame: 2 Months ]
  6. Impact of donor titers level on efficacy [ Time Frame: 2 Months ]
  7. Patients' anti-SARS-CoV2 titer assessment pre-infusion for the Treatment group, at 2 weeks , 4 weeks and 2 months. [ Time Frame: Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months ]

Other Outcome Measures:
  1. Plasma product's cytokine level assessment [ Time Frame: Day 0 ]
    Univariate test will be performed in terms of identifying the association between exploratory objective and the hospitalization rate, Mantel-Haenszel test for categorical variables, and t-test or its non-parametric version for the continuous variables based on the normalized of the data.

  2. Plasma product's mannose-binding lectin (MBL) level assessment [ Time Frame: Day 0 ]
  3. Plasma product's procalcitonin (PCT) level assessment [ Time Frame: Day 0 ]
  4. Plasma product's C-reactive protein (CRP) level assessment [ Time Frame: Day 0 ]
  5. Plasma product's Human neutrophil lipocalin (HNL) level assessment [ Time Frame: Day 0 ]
  6. Plasma product's Annexin V level assessment [ Time Frame: Day 0 ]
  7. Plasma product's Surfactant protein D (SP-D) level assessment [ Time Frame: Day 0 ]
  8. Plasma product's microRNA level assessment [ Time Frame: Day 0 ]
  9. Plasma product's immunoglobulin level assessment [ Time Frame: Day 0 ]
  10. Patients' cytokines levels assessment at +2 and +4 weeks post randomization [ Time Frame: 2 Weeks and 4 Weeks ]
  11. Patients' chemokines levels assessment at +2 and +4 weeks post randomization [ Time Frame: 2 Weeks and 4 Weeks ]
  12. Rates of adverse events associated with convalescent plasma infusion. [ Time Frame: Day 3 and 7, Weeks 2 and 4 ]
    Safety assessment will be performed on infusion day for the Treatment group (immediately post infusion), and for all patients on randomization day +3 and +7 days (by telephone, closest business day is acceptable), +2 weeks (+/- 3 days), +4 weeks (+/- 3 days).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456413


Contacts
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Contact: Mariefel Vendivil 551-996-5828 Mariefel.Vendivil@HackensackMeridian.org
Contact: Marlo Kemp 551-996-4464 Marlo.Kemp@HackensackMeridian.org

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Mariefel Vendivil    551-996-5828    Mariefel.Vendivil@HackensackMeridian.org   
Contact: Marlo Kemp    551-996-4464    Marlo.Kemp@HackensackMeridian.org   
Principal Investigator: Michele L Donato, MD         
Sponsors and Collaborators
Hackensack Meridian Health
United States Department of Defense
Investigators
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Principal Investigator: Michele L Donato, MD Hackensack Meridian Health
  Study Documents (Full-Text)

Documents provided by Hackensack Meridian Health:
Informed Consent Form  [PDF] February 17, 2021

More Information
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Publications:

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT04456413    
Other Study ID Numbers: Pro2020-0542
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hackensack Meridian Health:
Coronavirus
Covid19
SARS-CoV-2
Additional relevant MeSH terms:
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Infection