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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: CCP

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Metro Infectious Disease Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: convalescent plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days
SAEs within 24 hours of plasma infusion		28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Inflammatory Markers	A 50% decrease at day 28 in C-Reactive Protein (mg/mL)	28 days
Decrease in Inflammatory Markers	A 50% decrease at day 28 in D-Dimer (ng/mL)	28 days
Decrease in Inflammatory Markers	A 50% decrease at day 28 in Ferritin (ng/mL)	28 days
Decrease in Inflammatory Markers	A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)	28 days
Hospitalization within 28 days		28 days

Collaborators and Investigators

• Sponsor: Metro Infectious Disease Consultants

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): August 12, 2020
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: convalescent plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MIDC-CCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No