COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04362176

Todd Rice, MD

todd.rice@vumc.org

2020-04-24

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: age greater than or equal to 18 years currently hospitalized or in an emergency department with anticipated hospitalization symptoms of acute respiratory infection, defined as one or more of the following: cough chills, or a fever (greater than 37.5° c or 99.5° f) shortness of breath, operationalized as a patient having any of the following: i. subjective shortness of breath reported by a patient or surrogate. ii. tachypnea with respiratory rate of greater than 22 breaths per minute iii. hypoxemia, defined as spo2 less than 92% on room air, new receipt of supplemental oxygen to maintain spo2 greater than or equal to 92%, or increased supplemental oxygen to maintain spo2 greater than or equal to 92% for a patient on chronic oxygen therapy laboratory-confirmed sars-cov-2 infection within the past 14 days

prisoner unable to randomize within 14 days after onset of acute respiratory infection symptoms patient, legal representative, or physician not committed to full support (exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.) inability to be contacted on day 29-36 for clinical outcome assessment receipt of any sars-cov-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days contraindications to transfusion or history of prior reactions to transfused blood products plan for hospital discharge within 24 hours of enrollment previous enrollment in this trial previous laboratory-confirmed sars-cov-2 infection before the current illness enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy prior receipt of sars-cov-2 vaccine

2

Vanderbilt University Medical Center

18

None

United States

No restriction on type of patients

0: No restriction on type of patients

974

COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score

None

Phase 3

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]