Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04385199
Study type Interventional
Source Henry Ford Health System
Contact
Status Completed
Phase Phase 2
Start date May 4, 2020
Completion date August 1, 2020

See also
  Status Clinical Trial Phase
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3
Active, not recruiting NCT04420676 - Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04425317 - Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients N/A
Completed NCT04395911 - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections N/A
Withdrawn NCT04456426 - Characteristics of Patients With COVID-19 in Meta State, Colombia
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Completed NCT04425720 - Use of Remote Monitoring for COVID-19 Patient N/A
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Completed NCT04419610 - RAS and Coagulopathy in COVID19 Early Phase 1
Completed NCT04546581 - Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) Phase 3
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04435327 - Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
Not yet recruiting NCT04524156 - COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2 N/A
Completed NCT04441710 - Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
Completed NCT04357834 - WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
Not yet recruiting NCT04392427 - New Antiviral Drugs for Treatment of COVID-19 Phase 3
Terminated NCT04614025 - Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19 Phase 2
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2