Status:
COMPLETED
Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to find out if CCP is safe and to determine the safest and most effective level of anti-viral antibody when given to people admitted to the hospital with confirme...
Detailed Description
This randomized, double-blinded, phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with less than 8 days of symptoms. Eligible participa...
Eligibility Criteria
Inclusion
- Age at least 18 years
- Ability and willingness of participant or Legally Authorized Representative (LAR) to give written informed consent.
- Laboratory confirmed diagnosis of infection with SARS-CoV-2 by PCR
- Hospitalized for COVID-19 with one or more respiratory or gastrointestinal (GI) symptoms:
- COVID-19 associated respiratory symptoms include but are not limited to: cough, shortness of breath, difficulty breathing, or sore throat
- COVID-19 associated GI symptoms include but are not limited to: loss of taste, loss of sense of smell, diarrhea, nausea, or vomiting,
- Note: Respiratory and GI symptoms other than those listed above, must be noted as acceptable and signed by study PI or designee.
Exclusion
- Receipt of pooled immunoglobulin in past 30 days
- Current or prior enrollment in a SARS-CoV-2 antibody or T-cell therapeutic study.
- Note: Patients enrolled on other randomized controlled trials of pharmaceutical and/or non-pharmaceutical interventions for COVID and meeting eligibility criteria will not be excluded, as determined by study PI (or designee) on a case-by-case basis and as allowed by eligibility criteria of the other trials.
- Contraindication to transfusion or history of prior reactions to transfusion blood products. This may include religious or cultural objections to receiving blood products and transfusions.
- ABO-compatible titered plasma is not available
- \> 10 days from noted COVID-related subjective or objective fever at randomization. Patients without subjective or objective fever, \> 10 days from symptom onset as determined by study PI.
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04524507
Start Date
August 27 2020
End Date
June 4 2021
Last Update
December 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina Health Care
Chapel Hill, North Carolina, United States, 27514