To evaluate the role of intermittent use of CPAP (continuous positive pressure ventilation) in hypoxemic patients with CVOID-19 infection requiring at least 10 liters of oxygen.
Design
Two arms parallel-group open-labeled randomized clinical trial
Settings and conduct
The trial will be conducted in the department of General Medicine in the specialized COVID isolation units. This is an open-labeled clinical trial conducted in patients with severe COVID pneumonia requiring oxygen supplementation of 10 liters or more.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- Age between 18 to 70 years
2- COVID-19 confirmed patients on 10 liters of oxygen or more.
Exclusion criteria:
1. Unco-operative patient
2. Pneumothorax
3. Surgical emphysema
4. GCS less than 13
5. Excessive respiratory secretions
6. Shock
Intervention groups
One group (control) will receive the conventional treatment while patients in the intervention group will be put on intermittent CPAP therapy. These patients will be put on CPAP for two hours in the morning and two hours in the evening. Patients will be kept in the intervention group until their oxygen demand reaches 30 liters or more.
Main outcome variables
The primary outcome will be assessed based on the in-hospital mortality.
Secondary outcomes will include the duration of hospital stay, patients requiring mechanical ventilation, and patients requiring the use of continuous CPAP or BiPAP therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200723048178N2
Registration date:2021-04-28, 1400/02/08
Registration timing:prospective
Last update:2021-04-28, 1400/02/08
Update count:0
Registration date
2021-04-28, 1400/02/08
Registrant information
Name
Ahmed Farhan
Name of organization / entity
Pakistan Institute of Medical Sciences
Country
Pakistan
Phone
+92 51 9261592
Email address
drfarhan992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-02, 1400/02/12
Expected recruitment end date
2022-05-01, 1401/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Trial of Intermittent CPAP use in Hypoxemic Patients with COVID-19 infection
Public title
Intermittent CPAP in hypoxemic COVID patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with severe COVID-19 infection
Patients requiring supplemental oxygen of 10 litres or more
Exclusion criteria:
Unco-operative patient
Patients with Pneumothorax
Patients with Surgical emphysema
GCS less than 13
Excessive respiratory secretions
Shock
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized using a "simple" randomization method with "individuals" considered as a single unit. A table of random numbers will be generated using "https://www.randomizer.org/". One set of patients will be labeled as "controls" while the other group will be labeled as the "Interventional Group". No concealment will be carried out (open-label).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Pakistan Institute of Medical Sciences, Islamabad
Street address
G-8/3, Islamabad
City
Islamabad
Postal code
44080
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
ECPIMS/20/04
Health conditions studied
1
Description of health condition studied
COVID-19 Infection
ICD-10 code
J12.81
ICD-10 code description
Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
Description
In-hospital mortality.
Timepoint
28 days after intervention
Method of measurement
A Questionnaire will be used to record the data.
Secondary outcomes
1
Description
The duration of hospital stay
Timepoint
28 days following the intervention
Method of measurement
A Questionnaire will be used to record the data.
2
Description
The use of non-invasive or invasive mechanical ventilation
Timepoint
28 days after intervention
Method of measurement
A Questionnaire will be used to record the data.
Intervention groups
1
Description
Intervention group: Patients in the intervention group will be applied CPAP masks for two hours in the morning and two hours in the evenings (total four hours), at least six hours apart. The CPAP pressure will be fixed at 5 mmHg. All patients in the interventional group will also receive conventional treatment. Conventional treatment will include the following: 1. Dexamethasone 6 mg intravenous once daily for 10 days, 2. Injection enoxaparin 60 mg subcutaneous once daily during the hospital stay, 3. Antibiotics as per the hospital protocol and physician's discretion, 4. Injection omeprazole 40 mg IV once daily during the hospital stay, 5. Injection Remdesivir 200 mg IV on day one then once daily for 5 to 10 days.
Category
Treatment - Devices
2
Description
Control group: The control group will receive only the conventional treatment. Conventional treatment will include the following: 1. Dexamethasone 6 mg intravenous once daily for 10 days, 2. Injection enoxaparin 60 mg subcutaneous once daily during the hospital stay, 3. Antibiotics as per the hospital protocol and physician's discretion, 4. Injection omeprazole 40 mg IV once daily during the hospital stay, 5. Injection Remdesivir 200 mg IV on day one then once daily for 5 to 10 days.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pakistan Institute of Medical Sciences, Islamabad.
Full name of responsible person
Ahmed Farhan
Street address
G-8/3, Islamabad
City
Islamabad
Postal code
44080
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://emedz.net/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pakistan Institute of Medical Sciences, Islamabad
Full name of responsible person
Ahmed Farhan
Street address
G-8/3, Islamabad
City
Islamabad
Postal code
44080
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://emedz.net/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pakistan Institute of Medical Sciences, Islamabad
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Pakistan Institute of Medical Sciences, Islamabad
Full name of responsible person
Ahmed Farhan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
G-8/3, Islamabad
City
Islamabad
Province
Punjab
Postal code
44080
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://emedz.net/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pakistan Institute of Medical Sciences, Islamabad
Full name of responsible person
Ahmed Farhan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
G-8/3, Islamabad
City
Islamabad
Province
Punjab
Postal code
44080
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://emedz.net/
Person responsible for updating data
Contact
Name of organization / entity
Pakistan Institute of Medical Sciences, Islamabad
Full name of responsible person
Ahmed Farhan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
G-8/3, Islamabad
City
Islamabad
Province
Punjab
Postal code
44080
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://emedz.net/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the relevant data will be shared.
When the data will become available and for how long
Data will be available for one year following the completion of the study.
To whom data/document is available
Data will be shared with all healthcare workers and policymakers.
Under which criteria data/document could be used
Information may be requested via email to the corresponding author. Data will be shared as SPSS outcome files.
From where data/document is obtainable
Data will be provided by the corresponding author. It will be shared via email.
email: drfarhan992@gmail.com
What processes are involved for a request to access data/document
Data may be provided via email on working days (Monday to Friday). It may take 3 to 5 days after the request is made.