The COVID-19 ICU PRAYER Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Behavioral: prayer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 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. | 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 | 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. | 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 | 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 | 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 |