Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
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ClinicalTrials.gov Identifier: NCT04438057 |
Recruitment Status :
Completed
First Posted : June 18, 2020
Last Update Posted : April 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Biological: CCP | Phase 2 |
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 (Clinical Trial) |
Actual Enrollment : | 103 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 |
Actual Study Completion Date : | August 12, 2021 |

Arm | Intervention/treatment |
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No Intervention: Standard of Care
Patient will receive standard of care therapy.
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Active Comparator: Treatment Arm
Patient will receive convalescent plasma
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Biological: CCP
Randomized open label study to receive 2:1 CCP to standard of care
Other Name: convalescent plasma |
- 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.
- SAEs within 24 hours of plasma infusion [ Time Frame: 28 days ]
- Decrease in Inflammatory Markers [ Time Frame: 28 days ]A 50% decrease at day 28 in C-Reactive Protein (mg/mL)
- Decrease in Inflammatory Markers [ Time Frame: 28 days ]A 50% decrease at day 28 in D-Dimer (ng/mL)
- Decrease in Inflammatory Markers [ Time Frame: 28 days ]A 50% decrease at day 28 in Ferritin (ng/mL)
- Decrease in Inflammatory Markers [ Time Frame: 28 days ]A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)
- Hospitalization within 28 days [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Illinois | |
Metro Infectious Disease Consultants | |
Burr Ridge, Illinois, United States, 60527 |
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: | April 6, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
convalescent plasma |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |