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

NCT04353206 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: Acute Care CP Consortium Trial
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid-19; Sars-CoV2

Keywords

convalescent plasma; Anti-Sars-COV-2 plasma

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who consent to the study and receive at least one dose of convalescent plasma.

  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.

  60 days

Secondary Outcomes (1)

• Overall survival of patients in the ICU receiving at least once dose of convalescent plasma for Covid-19-induced respiratory failure.

  60 days

Study Arms (1)

Intubated COVID-19 patients in the ICU

EXPERIMENTAL

Mechanically ventilated intubated patients with respiratory failure due to COVID-19

Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma

Interventions

Multiple Doses of Anti-SARS-CoV-2 convalescent plasma BIOLOGICAL

Subjects to receive single or double plasma units infused on day 0 and potentially days 3 and 6.

Also known as: convalescent plasma, covid-19 convalescent plasma, anti-SARS-CoV-2 convalescent plasma

Intubated COVID-19 patients in the ICU

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Respiratory failure caused by illness other than SARS-CoV-2
• Other documented uncontrolled infection.
• 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

Sponsors & Collaborators

• Noah Merin: lead
• Johns Hopkins University: collaborator

Study Sites (2)

8700 Beverly Blvd.

Los Angeles, California, 90048, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Noah Merin, MD PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• David Hager, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: June 27, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

US (2)