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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
Metro Infectious Disease Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring convalescent plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 17, 2020
Last Updated
April 4, 2022
Sponsor
Metro Infectious Disease Consultants
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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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