Clinical trial NCT04385199: Convalescent Plasma for Patients With COVID-19
Official title: The Use of Convalescent Plasma for Patients Hospitalized With COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronavirus Infection
Coronavirus
COVID
Keywords: COVID-19
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief summary: Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.

Detailed description: Importance: Convalescent plasma has been shown to be safe in patients with COVID-19, but whether it is clinically effective in patients with severe COVID-19 pneumonia is still unclear.

Objective: To evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical COVID-19 pneumonia.

Design, Setting and Participants: Randomized, single center, open-label, controlled trial of patients hospitalized between May 1, 2020, and August 1, 2020, with severe COVID-19 pneumonia in 1 tertiary care health system in the United States. A total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate \> 30; O2 saturation ≤ 93%; PaO2/FiO2 or SaO2/FiO2 ratio \< 300 mm Hg; and bilateral airspace opacities on chest x-ray \> 50% within 24 to 48 hours.

Intervention: Transfusion with 1 unit of ABO compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). Standard care included steroids.

Main Outcomes and Measures: Primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in PaO2/FiO2 or Sa/FiO2. Secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and mSOFA score.

Eligibility criteria: Inclusion Criteria:

* age \> 18 with one or more of the following: Dyspnea Respiratory rate \>= 30 breaths/min Oxygen saturation \<=93% PaO2/FiO2 \<300 Bilateral airspace opacities on chest radiograph at 24 to 48 hours

Exclusion Criteria:

* Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO

Primary outcomes:
measure: Change in Respiratory Disease Severity
timeFrame: day 3 post transfusion
Secondary outcomes:
measure: ICU Length of Stay
timeFrame: Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated.
measure: Length of Stay
timeFrame: Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated.
measure: Ventilator Days
timeFrame: 28 day
measure: Number of Participants With Transfusion Adverse Events
timeFrame: From transfusion up to 1 day post-transfusion
measure: Normal Chest X Ray at 28 Days
timeFrame: 28 days
measure: All-cause Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Geneva Tatem, MD
role: PRINCIPAL_INVESTIGATOR
References: