Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
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|ClinicalTrials.gov Identifier: NCT04438057|
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|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)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Outpatient open label randomized study|
|Masking:||None (Open Label)|
|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|
|Estimated Study Completion Date :||August 12, 2021|
No Intervention: Standard of Care
Patient will receive standard of care therapy.
Active Comparator: Treatment Arm
Patient will receive convalescent plasma
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 ]
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