Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CCP
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring convalescent plasma
Eligibility 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
Sites / Locations
- Metro Infectious Disease Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard of Care
Treatment Arm
Arm Description
Patient will receive standard of care therapy.
Patient will receive convalescent plasma
Outcomes
Primary Outcome Measures
Time to Resolution of Symptoms
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.
SAEs within 24 hours of plasma infusion
Secondary Outcome Measures
Decrease in Inflammatory Markers
A 50% decrease at day 28 in C-Reactive Protein (mg/mL)
Decrease in Inflammatory Markers
A 50% decrease at day 28 in D-Dimer (ng/mL)
Decrease in Inflammatory Markers
A 50% decrease at day 28 in Ferritin (ng/mL)
Decrease in Inflammatory Markers
A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)
Hospitalization within 28 days
Full Information
NCT ID
NCT04438057
First Posted
June 17, 2020
Last Updated
April 4, 2022
Sponsor
Metro Infectious Disease Consultants
1. Study Identification
Unique Protocol Identification Number
NCT04438057
Brief Title
Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Official Title
Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
August 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metro Infectious Disease Consultants
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
convalescent plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Outpatient open label randomized study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patient will receive standard of care therapy.
Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
Patient will receive convalescent plasma
Intervention Type
Biological
Intervention Name(s)
CCP
Other Intervention Name(s)
convalescent plasma
Intervention Description
Randomized open label study to receive 2:1 CCP to standard of care
Primary Outcome Measure Information:
Title
Time to Resolution of Symptoms
Description
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.
Time Frame
28 days
Title
SAEs within 24 hours of plasma infusion
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Decrease in Inflammatory Markers
Description
A 50% decrease at day 28 in C-Reactive Protein (mg/mL)
Time Frame
28 days
Title
Decrease in Inflammatory Markers
Description
A 50% decrease at day 28 in D-Dimer (ng/mL)
Time Frame
28 days
Title
Decrease in Inflammatory Markers
Description
A 50% decrease at day 28 in Ferritin (ng/mL)
Time Frame
28 days
Title
Decrease in Inflammatory Markers
Description
A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)
Time Frame
28 days
Title
Hospitalization within 28 days
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Metro Infectious Disease Consultants
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
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