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Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure

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ClinicalTrials.gov Identifier: NCT04353206
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Noah Merin, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE April 16, 2020
First Posted Date  ICMJE April 20, 2020
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE June 27, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2020)
Proportion of subjects who consent to the study and receive at least one dose of convalescent plasma. [ Time Frame: 60 days ]
Feasibility of administering convalescent plasma to patients in the ICU who are intubated and mechanically ventilated due to COVID-19-induced respiratory failure will be assessed based on the proportion of subjects who consent and receive at least one dose of CP. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
To determine feasibility of administering CP to patients in the ICU who intubated and mechanically ventilated due to COVID-19-induced respiratory failure. [ Time Frame: 60 days ]
Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of CP. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2020)
Overall survival of patients in the ICU receiving at least once dose of convalescent plasma for Covid-19-induced respiratory failure. [ Time Frame: 60 days ]
Overall survival (days, until Day 60). This will be quantified as number of trial patients alive at Day 60 after first dose of CP / total number of patients who received at least one dose of CP.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
To determine overall survival of patients in the ICU receiving at least once dose of CP for Covid-19-induced respiratory failure. [ Time Frame: 60 days ]
Overall survival (days, until Day 60). This will be quantified as number of trial patients alive at Day 60 after first dose of CP / total number of patients who received at least one dose of CP.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure
Official Title  ICMJE A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19
Brief Summary

This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use.

Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.

The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.

Detailed Description

Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. It is important that we evaluate this potential therapy in the context of clinical trials.

As such, this study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use.

This study will be opened across three separate site: Cedars-Sinai Medical Center, Johns Hopkins University, and University of Pittsburgh Medical Center. 30 patients will be recruited at each site. Each site has received its own FDA IND and IRB approval. As such, the following people are serving as sponsor-investigators at their respective institutions.

David Hager, MD PhD, Johns Hopkins University

Noah Merin, MD PhD, Cedars-Sinai Medical Center

Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.

The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid-19
  • Sars-CoV2
Intervention  ICMJE Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma
Subjects to receive single or double plasma units infused on day 0 and potentially days 3 and 6.
Other Names:
  • convalescent plasma
  • covid-19 convalescent plasma
  • anti-SARS-CoV-2 convalescent plasma
Study Arms  ICMJE Experimental: Intubated COVID-19 patients in the ICU
Mechanically ventilated intubated patients with respiratory failure due to COVID-19
Intervention: Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2020)
90
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older
  • Respiratory failure requiring mechanical ventilation due to COVID-19 induced pneumonia with confirmation via SARS-CoV-2 RT-PCR testing
  • PaO2/FiO2 ratio < 300 (or SpO2/FiO2 < 315)
  • Bilateral pulmonary infiltrates

Exclusion Criteria:

  • Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
  • In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours.
  • Acute or chronic disease/illness that, in the opinion of the site investigator, has an expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia (e.g.; stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.)
  • Use of home oxygen at baseline
  • Use of home mechanical ventilation at baseline (CPAP or BIPAP without need for oxygen is NOT an exclusion)
  • Respiratory failure caused by illness other than SARS-CoV-2
  • Other documented uncontrolled infection.
  • More than 72 hours have elapsed since first meeting inclusion criteria
  • Severe DIC, TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate.
  • Patient is on Warfarin and it is deemed necessary to maintain therapeutic INR (because the CP will reverse the warfarin effect).
  • On dialysis at the time enrollment is considered.
  • Active intracranial bleeding.
  • Clinically significant myocardial ischemia.
  • Prisoner or Incarceration
  • Pregnancy or active breast feeding
  • Has already received convalescent plasma for COVID-19 infection during current admission
  • Current participation in another interventional research study
  • Inability or unwillingness of subject or legal surrogate/representative to give written informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Noah Merin, MD PhD 310-423-1160 Noah.Merin@cshs.org
Contact: David Hager, MD PhD dhager1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04353206
Other Study ID Numbers  ICMJE Acute Care CP Consortium Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Noah Merin, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Noah Merin
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Noah Merin, MD PhD Cedars-Sinai Medical Center
Principal Investigator: David Hager, MD PhD Johns Hopkins University
PRS Account Cedars-Sinai Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP