Clinical trial NCT04631380: Prayer in Commbate to Corona Virus - Covid -19
Official title: A Double Blind, Controlled, Randomized, Prospective Study That Will Evaluate the Impact of Remote Intercession Prayer on the Clinical Evolution of Patients Diagnosed With COVID -19 in HCOR.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PROSPECTIVE RANDOMIZED DOUBLE-BLIND STUDY
Primary purpose: OTHER

Brief summary: PATIENTS WHO ARE ADMITTED TO HOSPITALIZATION IN HCOR AND WHO HAVE THE CONFIRMED DIAGNOSIS OF CORONA VIRUS, WILL BE ASKED TO CONSENT TO PARTICIPATE IN THIS STUDY THAT INTENDS TO STUDY THE EFFECTIVENESS OF THE REMOTE INTERCESSION PRAYER IN COMBATING THIS DISEASE.

Detailed description: PATIENTS WHO AGREE TO PARTICIPATE IN THE STUDY WILL BE SEPARATED INTO 2 GROUPS, THE INTERVENTION GROUP AND THE CONTROL GROUP.

THE IDENTITY OF THE PATIENTS WILL BE KEPT IN SECRET AND ONLY THEIR INITIALS WILL BE LISTED.

THE INTERVENTION GROUP WILL RECEIVE DAILY PRAYERS AND THE EVOLUTIONARY CLINICAL RESULTS OF THE TWO GROUPS WILL BE PURCHASED.

Eligibility criteria: Inclusion Criteria:

Patients hospitalized in comun hospital rooms and intensive care units with confirmed COVID-19.

Exclusion Criteria:

* Patients admitted to the HCor emergency room, diagnosed with COVID-19 infection, however, without indication for hospitalization
* Patients admitted to the HCor emergency room, diagnosed with COVID-19 infection, however, without indication for hospitalization.
* Patients 18 years of age or older
* Patients with indication of palliative care and definition of terminality at hospital admission
* Patients who voluntarily choose not to participate in the study at the time of the • presentation of the Informed Consent Form.

Primary outcomes:
measure: DEATH OR RECOVERY
timeFrame: 60 DAYS
Secondary outcomes:
measure: NEED FOR MECHANICAL VENTILATION
timeFrame: 60 DAYS
measure: TIME OF REMAINED INTUBATED
timeFrame: 60 DAYS
measure: LENGTH OF STAY IN ICU
timeFrame: 60 DAYS
measure: TIME OF STAY HOSPITALIZED
timeFrame: 60 DAYS
measure: Occurrence of clinical complications.
timeFrame: 60 DAYS
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
state: SP
Study officials:
affiliation: Hospital do Coracao
name: NATHAN V SOUBIHE JR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hettiaratchy S, Hemsley C. Effect of retroactive intercessory prayer. Paper proves power of statistics, not prayer. BMJ. 2002 Apr 27;324(7344):1037; author reply 1038-9. No abstract available.
citation: Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, Forker A, O'Keefe JH, McCallister BD. A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Intern Med. 1999 Oct 25;159(19):2273-8. doi: 10.1001/archinte.159.19.2273.
citation: Hoover DR, Margolick JB. Questions on the design and findings of a randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Intern Med. 2000 Jun 26;160(12):1875-6; author reply 1877-8. doi: 10.1001/archinte.160.12.1875-b. No abstract available.
citation: Radin D, Schlitz M, Baur C. Distant Healing Intention Therapies: An Overview of the Scientific Evidence. Glob Adv Health Med. 2015 Nov;4(Suppl):67-71. doi: 10.7453/gahmj.2015.012.suppl. Epub 2015 Nov 1.
citation: Bleich A. [Intercessory prayer for health: a matter of faith, science or both]. Harefuah. 2002 Jun;141(6):522-3. No abstract available. Hebrew.