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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Covid-19 Sars-CoV2 Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 27, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intubated COVID-19 patients in the ICU
Mechanically ventilated intubated patients with respiratory failure due to COVID-19
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353206


Contacts
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Contact: Noah Merin, MD PhD 310-423-1160 Noah.Merin@cshs.org
Contact: David Hager, MD PhD dhager1@jhmi.edu

Locations
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United States, California
8700 Beverly Blvd. Recruiting
Los Angeles, California, United States, 90048
Contact: Noah Merin, MD PhD    310-423-1160    Noah.Merin@cshs.org   
Principal Investigator: Noah Merin, MD PhD         
Sub-Investigator: Ellen Klapper, MD         
Sub-Investigator: Akil Merchant, MD         
Sub-Investigator: Justin Darrah, MD         
Sub-Investigator: Rachel Zabner, MD         
Sub-Investigator: Jillian Oft, MD         
Sub-Investigator: Philip Cheng, MD         
Sub-Investigator: Catherine Le, MD         
Sub-Investigator: Peter Chen, MD         
Sub-Investigator: Daving NG, MD         
Sub-Investigator: Eric Vail, MD         
Sub-Investigator: Anders Berg, MD PhD         
Sub-Investigator: Jenny Van Eyk, PhD         
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: David N Hager, MD PhD       dhager1@jhmi.edu   
Sponsors and Collaborators
Noah Merin
Johns Hopkins University
Investigators
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Principal Investigator: Noah Merin, MD PhD Cedars-Sinai Medical Center
Principal Investigator: David Hager, MD PhD Johns Hopkins University
Publications:

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Responsible Party: Noah Merin, Assistant Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04353206    
Other Study ID Numbers: Acute Care CP Consortium Trial
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noah Merin, Cedars-Sinai Medical Center:
convalescent plasma
Anti-Sars-COV-2 plasma
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases