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Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19

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ClinicalTrials.gov Identifier: NCT04438057
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Metro Infectious Disease Consultants

Study Description
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Brief Summary:
This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: CCP Phase 2

Detailed Description:

This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.

Following patient enrollment into the study, completion of informed consent and randomization, the patient will receive one unit of convalescent COVID plasma or standard of care. The plasma will be infused in an outpatient infusion center by highly trained and experienced staff. Vitalant will be providing the plasma as per their normal screening and distribution protocols. Patients will be monitored for safety during the infusion and per protocol following the infusion for a period of 28 days. Primary efficacy and safety endpoints will be statistically analyzed and compared between the two groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Outpatient open label randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Actual Study Start Date : August 12, 2020
Actual Primary Completion Date : August 12, 2020
Estimated Study Completion Date : August 12, 2021
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard of Care
Patient will receive standard of care therapy.
Active Comparator: Treatment Arm
Patient will receive convalescent plasma
 Biological: CCP
Randomized open label study to receive 2:1 CCP to standard of care
Other Name: convalescent plasma


Outcome Measures
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Primary Outcome Measures :
  1. Time to Resolution of Symptoms [ Time Frame: 28 days ]
    a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted.

  2. SAEs within 24 hours of plasma infusion [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Decrease in Inflammatory Markers [ Time Frame: 28 days ]
    A 50% decrease at day 28 in C-Reactive Protein (mg/mL)

  2. Decrease in Inflammatory Markers [ Time Frame: 28 days ]
    A 50% decrease at day 28 in D-Dimer (ng/mL)

  3. Decrease in Inflammatory Markers [ Time Frame: 28 days ]
    A 50% decrease at day 28 in Ferritin (ng/mL)

  4. Decrease in Inflammatory Markers [ Time Frame: 28 days ]
    A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)

  5. Hospitalization within 28 days [ Time Frame: 28 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

Inclusion Criteria:

  • Laboratory confirmed diagnosis of infection with SARS-CoV-2
  • Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia
  • Symptoms less than 14 days
  • ID Physician determination that the patient does not need hospitalization
  • O2 saturation of >93%
  • Informed consent provided by the patient or healthcare proxy
  • Age ≥ 18 years
  • Ambulatory Outpatient when informed consent obtained and study drug is administered

Exclusion Criteria:

  • Age < 18 y/o
  • Patients currently receiving intravenous immunoglobulin
  • Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic syndrome, chronic anticoagulation treatment, etc.
  • Need to be hospitalized
  • O2 sat < 93%
  • D-Dimer > 2x normal
  • Chronic oxygen therapy
  • Renal insufficiency with Creatinine clearance < 30
  • Long term care or assisted living facility resident
  • Ongoing usage of hydroxychloroquine for any indication
  • History of blood or plasma transfusion related complications
  • Enrollment into any other investigational drug or device study within the previous 30 days
  • Any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up
  • Pregnant or breast feeding
  • Any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety
  • Admitted to or expected to be admitted to a medical facility
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): NCT04438057


Locations
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United States, Illinois
Metro Infectious Disease Consultants Recruiting
Burr Ridge, Illinois, United States, 60527
Contact: Nicholas Van Hise, PharmD    630-655-6952    nvanhise@midcusa.com   
Contact: Nathan Skorodin, PharmD       nskorodin@midcusa.com   
Sponsors and Collaborators
Metro Infectious Disease Consultants
More Information
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Responsible Party: Metro Infectious Disease Consultants
ClinicalTrials.gov Identifier: NCT04438057    
Other Study ID Numbers: MIDC-CCP
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
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 Metro Infectious Disease Consultants:
convalescent plasma