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The COVID-19 ICU PRAYER Study

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: NCT04361838
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kansas City Heart Rhythm Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Behavioral: prayer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04361838


Contacts
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Contact: Dhanunjaya Lakkireddy, MD 913-449-1297 dhanunjaya.lakkireddy@hcahealthcare.com
Contact: Donita Atkins, RN, BSN 913-449-1297 donita.atkins@hcahealthcare.com

Sponsors and Collaborators
Kansas City Heart Rhythm Institute
Investigators
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Principal Investigator: Dhanunjaya Lakkireddy, MD Kansas City Heart Rhythm Institute
Publications:

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Responsible Party: Kansas City Heart Rhythm Institute
ClinicalTrials.gov Identifier: NCT04361838    
Other Study ID Numbers: Covid Prayer Study
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases