Covid19NCT04631380
Prayer in Commbate to Corona Virus - Covid -19
A study testing PRAYER in people with Covid19, run by Hospital do Coracao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- PRAYER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized in comun hospital rooms and intensive care units with confirmed COVID-19.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- PRAYER
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRAYEROther
Also called INTERCESSORY PRAYER
THE PRAYER GROUP WILL RECEIVE ABSOLUTELY THE SAME CARE AS THE CONTROL GROUP PLUS PRAYERS
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | THIS GROUP WILL RECEIVE THE PROTCOLL TREATMENT GIVEN TO PATIENTS COVID -POSITIVE TESTED. |
| PRAYER | Experimental | THIS GROUP WILL RECEIVE THE SAME TREATMENT GIVEN TO THE CONTROL GROUP, PLUS PRAYERS BY THEOLOGIANS WHOSE PRAYERS INTERCEDE IN FAVOR OF THEIR PROMPT RECOVERY Receives: Other: PRAYER |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEATH OR RECOVERY
WE WILL EVALUATE DEATHS OR HOSPITAL DISCHARGE
Measured: 60 DAYS
Secondary outcomes (5)
NEED FOR MECHANICAL VENTILATION
NEED FOR MECHANICAL VENTILATION
Measured: 60 DAYS
TIME OF REMAINED INTUBATED
TIME OF REMAINED INTUBATED
Measured: 60 DAYS
LENGTH OF STAY IN ICU
LENGTH OF STAY IN ICU
Measured: 60 DAYS
TIME OF STAY HOSPITALIZED
TIME OF STAY HOSPITALIZED
Measured: 60 DAYS
Occurrence of clinical complications.
Occurrence of clinical complications that were not included before diagnostic confirmation and that may be related to covid infection.
Measured: 60 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Aug 2020
- Primary completion1 Jun 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PROSPECTIVE RANDOMIZED DOUBLE-BLIND STUDY
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NATHAN V SOUBIHE JR, Principal investigator, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631380
- Sponsor's protocol ID
- PRAYER-COVID19
- Status last verified
- Mar 2022
- First submitted
- 4 Aug 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: They will not
Publications
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.
PubMed 11977259Harris 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.
PubMed 10547166Hoover 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.
PubMed 10871995Radin 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.
PubMed 26665044Bleich A. [Intercessory prayer for health: a matter of faith, science or both]. Harefuah. 2002 Jun;141(6):522-3. No abstract available. Hebrew.
PubMed 12119766
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04631380
- Acronym / sponsor ID
- PRAYER-COVID19
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PROSPECTIVE RANDOMIZED DOUBLE-BLIND STUDY
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –THIS GROUP WILL RECEIVE THE PROTCOLL TREATMENT GIVEN TO PATIENTS COVID -POSITIVE TESTED. |
| PRAYER | Experimental | Other: PRAYERTHIS GROUP WILL RECEIVE THE SAME TREATMENT GIVEN TO THE CONTROL GROUP, PLUS PRAYERS BY THEOLOGIANS WHOSE PRAYERS INTERCEDE IN FAVOR OF THEIR PROMPT RECOVERY |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients hospitalized in comun hospital rooms and intensive care units with confirmed COVID-19.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRAYERAlso: INTERCESSORY PRAYERTHE PRAYER GROUP WILL RECEIVE ABSOLUTELY THE SAME CARE AS THE CONTROL GROUP PLUS PRAYERS | Other | PRAYER |
Primary outcome
DEATH OR RECOVERY
Time frame: 60 DAYS
WE WILL EVALUATE DEATHS OR HOSPITAL DISCHARGE
5 secondary outcomes
NEED FOR MECHANICAL VENTILATION
Time frame: 60 DAYS
TIME OF REMAINED INTUBATED
Time frame: 60 DAYS
LENGTH OF STAY IN ICU
Time frame: 60 DAYS
TIME OF STAY HOSPITALIZED
Time frame: 60 DAYS
Occurrence of clinical complications.
Time frame: 60 DAYS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 11977259Hettiaratchy 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.
- Background: PubMed 10547166Harris 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.
- Background: PubMed 10871995Hoover 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.
- Background: PubMed 26665044Radin 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.
- Background: PubMed 12119766Bleich A. [Intercessory prayer for health: a matter of faith, science or both]. Harefuah. 2002 Jun;141(6):522-3. No abstract available. Hebrew.
- Individual participant dataSharing planned: No. They will not
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NATHAN V SOUBIHE JR principal investigator
Hospital do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRAYER in people with Covid19, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEATH OR RECOVERY (time frame: 60 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631380, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.