Convalescent Plasma for Patients With COVID-19

NCT04385199 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 13807
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronavirus Infection; Coronavirus; COVID

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in Respiratory Disease Severity

  Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion

  day 3 post transfusion

Secondary Outcomes (6)

• ICU Length of Stay

  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.

• Length of Stay

  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.

• Ventilator Days

  28 day

• Number of Participants With Transfusion Adverse Events

  From transfusion up to 1 day post-transfusion

• Normal Chest X Ray at 28 Days

  28 days

Study Arms (2)

Convalescent Plasma Intervention

EXPERIMENTAL

Convalescent plasma 200mL transfusion

Biological: Convalescent plasma

Standard Therapy Control

NO INTERVENTION

Standard therapy for COVID-19 disease as defined by institutional protocols

Interventions

Convalescent plasma BIOLOGICAL

One 200mL transfusion of ABO compatible convalescent plasma over 3 hours

Convalescent Plasma Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Geneva Tatem
• Organization: Henry Ford Health System

gtatem1@hfhs.org

313-916-2431

Study Officials

• Geneva Tatem, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Medicine

Model Details: Randomized control trial

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 12, 2020
• Study Start: May 4, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 2, 2022
• Results First Posted: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)