Status:
WITHDRAWN
Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection
Lead Sponsor:
Larkin Community Hospital
Conditions:
Covid19
Eligibility:
All Genders
40-65 years
Phase:
PHASE3
Brief Summary
The expanded access program for investigational convalescent plasma (CP) is being utilized nationwide despite its unproven benefit and optimal timing of transfusion. The optimal administration of CP d...
Detailed Description
Based on previous veterinary and human studies of coronavirus vaccines, it is probable that an effective vaccine is 1-2 years away. Multiple antiviral medications are being currently studied, but manu...
Eligibility Criteria
Inclusion
- Admitted to the participating acute care facilities as listed above (Larkin Palm Springs Hospital, Larkin South Miami Hospital) AND enrolled in the trial within 48 hours of hospital admission (defined by when admission order was placed) AND
- Age ≥ 40 with at least one of the following comorbidities (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, pulmonary hypertension, idiopathic pulmonary fibrosis, asthma, COPD, cancer, HIV/AIDS, chronic kidney disease, immunosuppression, obesity). OR
- Age ≥ 65 years of age with or without comorbid conditions. AND
- Severe or life-threatening COVID-19 disease as defined by the FDA:
- "Severe disease is defined as one or more of the following: shortness of breath (dyspnea), respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, lung infiltrates \> 50% within 24 to 48 hours, Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure AND
- Positive COVID-19 test via nasopharyngeal or pharyngeal PCR.
- Able to consent to treatment
Exclusion
- Unable to consent
- Lack of laboratory confirmed COVID-19 infection.
- Hospice/Palliative care
- Unable to tolerate 200mL of fluid.
- History of IgA deficiency (due to risk of reaction)
- History of anaphylactoid or other severe reaction to plasma or blood products.
- Philosophical/Religious objections to receiving blood products.
- Pregnant or breastfeeding
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06084351
Start Date
May 12 2020
End Date
October 30 2020
Last Update
October 16 2023
Active Locations (1)
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1
Larkin Community Hospital
South Miami, Florida, United States, 33143