Convalescent Plasma in Outpatients With COVID-19 (C3PO)
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|ClinicalTrials.gov Identifier: NCT04355767|
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2020
Last Update Posted : November 17, 2020
The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.
This study will adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: Convalescent Plasma Biological: Saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Clinical-trial of COVID-19 Convalescent Plasma in Outpatients|
|Actual Study Start Date :||August 11, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Convalescent Plasma
Participants receive 1 unit of convalescent plasma.
Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
Placebo Comparator: Placebo
Participants receive 1 unit of saline with multivitamin.
Saline with multivitamin administered via intravenous (IV) infusion..
- Number of patients with disease progression [ Time Frame: 15 days ]Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
- Worst severity rating on the WHO COVID Ordinal Scale for Clinical Improvement during the 30 days following randomization [ Time Frame: 30 days ]
This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.
- 8 = Death
- 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy)
- 6 = Hospitalized, intubated and mechanically ventilated
- 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula
- 4 = Hospitalized on supplemental oxygen by mask or nasal prongs
- 3 = Hospitalized not on supplemental oxygen
- 2 = Not hospitalized with limitation in activity (continued symptoms)
- 1 = Not hospitalized without limitation in activity (no symptoms)
- Time to disease progression [ Time Frame: 15 days ]
Time to disease progression on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period.
COVID Outpatient Ordinal Outcomes Scale
- 1 = patient requires care in the hospital
- 2 = patient requires care in the ED or urgent care
- 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain)
- 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness
- 5 = patient in their usual state of health
- Number of Hospital-free days during the 30 days following randomization [ Time Frame: 30 days ]
- All-cause mortality [ Time Frame: Assessed at 30 days ]
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): NCT04355767
|Principal Investigator:||Clifton W Callaway, MD, PhD||University of Pittsburgh|
|Principal Investigator:||Valerie Durkalski-Mauldin, PhD||Medical University of South Carolina|
|Principal Investigator:||Frederick Korley, MD, PhD||University of Michigan|
|Principal Investigator:||Sharon Yeatts, PhD||Medical University of South Carolina|
|Principal Investigator:||Robert Silbergleit, MD||University of Michigan|
|Principal Investigator:||William Barsan, MD||University of Michigan|
|Study Director:||Kevin Schulman, MD||Stanford University|