The COVID-19 ICU PRAYER Study

February 1, 2022 updated by: Kansas City Heart Rhythm Institute

Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection

This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 106 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female greater than 18 years of age
  • Confirmed positive for COVID-19
  • Patient admitted to Intensive Care Unit

Exclusion Criteria:

  • Patients admitted to ICU for diagnosis that is not COVID-19 positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prayer
Patients will receive a daily prayer and standard of care treatment from multi-denominational group while in the ICU.
Behavioral: prayer
receive prayers daily while in ICU
No Intervention: No Prayer
Patients will receive standard of care treatment while in the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality.
Time Frame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.
daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score.
Time Frame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.
APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.
daily until patient recovers and moves out of ICU or exits the study, up to 30 days.
Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score
Time Frame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
The higher the SOFA score the increased likelihood of organ failure.
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Difference in patient outcomes - Length of stay in ICU.
Time Frame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
A prolonged length of time in ICU increases mortality.
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Difference in patient outcomes - Length of ventilator support
Time Frame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
A prolonged length of time with ventilator support increases mortality.
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Difference in patient outcomes - length of vasopressor support
Time Frame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
A prolonged length of time with vasopressor support increases recovery time.
daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Institute

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Covid Prayer Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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