COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04524507

Luther A Bartelt, MD

JoAnn Kuruc, joann_kuruc@med.unc.edu (PI email not reported)

2020-08-24

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: 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.

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.

2

University of North Carolina, Chapel Hill

18

99

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

56

Median Time to Hospital Discharge (or Discharge Equivalent) Following First Dose of CCP;Total Number of Serious Adverse Events (SAE) Through Study Day 14

None

Phase 2

[{"arm_notes": "high-titer ABO-compatible convalescent COVID-19 plasma", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "standard-titer ABO-compatible convalescent COVID-19 plasma", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}]