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NCT04363034 Clinical Trial

Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

COVID-19 Clinical Trial

Official title:
Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04363034
Other study ID # 260944
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date March 2023
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.

Description:

This is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or Female - 18 years of age or older - Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing - Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19. - Severe disease, defined as one or more of the following: - dyspnea, - respiratory frequency = 30/min, - blood oxygen saturation = 93%, - partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or - lung infiltrates > 50% within 24 to 48 hours - Life-threatening disease, defined as one or more of the following: - respiratory failure, - septic shock, and/or - multiple organ dysfunction or failure - Patients or their legally authorized representative must provide informed consent. Exclusion Criteria: - Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. - Patients who have received pooled immunoglobulin in past 30 days - Contraindication to transfusions or history of prior reactions to transfusion blood products

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Convalescent Plasma
1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Arkansas
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