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Determining the effect of skin test purified protein derivative (PPD) on the recovery process of patients with COVID 19 in patients with this disease

Protocol summary

Study aim
Determining the effect of skin test purified protein derivative (PPD) on the recovery process of patients with COVID 19 in patients with this disease
Design
Determining the effect of skin test purified protein derivative (PPD) on the recovery process of patients with COVID 19 in patients with this disease
Settings and conduct
After registering the patient's personal details, including name and surname, gender, age, weight, place of residence, occupation, the presence of underlying diseases and disease profile, randomly assigned to one of the two groups tested and controlled based on AB and randomized block design. BA. Is placed.   The control group includes those who receive only the usual treatment with chloroquine and Lopinavir / Ritonavir, and the control group, in addition to the treatment with the above-mentioned common drugs, also performs ppd (purified protein derivative )testing for them. We inoculate one-tenth of a milliliter, and the assessment is performed by an infectious disease specialist through daily trials for patients and a CT scan of the chest on days 3, 0, and 7, and a corona test on days 14-7 for patients to relieve fever.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: All patients diagnosed with covid-19. Output criteria: Patients with respiratory distress - which includes 1. Spo2 <60% 2. Severe respiratory distress 3. Heamodynamic instabilitty 4. Acid base disturbance 5. Severe Anemia    Patients with liver problems - People with nervous system defects
Intervention groups
All patients diagnosed with covid-19
Main outcome variables
Faster and less complicated recovery in patients with covid 19

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200414047070N1
Registration date: 2020-04-21, 1399/02/02
Registration timing: prospective

Last update: 2020-04-21, 1399/02/02
Update count: 0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
abdolah azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 4200
Email address
hadiazizi2323@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of skin test purified protein derivative (PPD) on the recovery process of patients with COVID 19 in patients with this disease
Public title
Effect of ppd on recovery of covid disease 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having covid 19
Exclusion criteria:
People with severe illness(. Spo2<60%2. Severe respiratory distress3. Heamodynamic instabilitty 4. Acid base disturbance 5. Severe Anemia) People with defective immune systems Liver disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
After registering the patient's personal details, including name and surname, gender, age, weight, place of residence, occupation, the presence of underlying diseases and disease profile, randomly assigned to one of the two groups tested and controlled based on AB and randomized block design. BA.
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 fasa University of Medical Sciences
Street address
Daneshgah
City
fasa
Province
Fars
Postal code
7461686688
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.FUMS.REC.1399.004

Health conditions studied

1

Description of health condition studied
Covid 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Having covid 19
Timepoint
3-7-14
Method of measurement
Negative test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: People with covid 19 Patients after accidental registration of personal information including name and surname, gender, age, weight, place of residence, job, the presence of underlying diseases and disease profile in one of the two intervention groups and Control based on AB and BA random block design. In addition to treatment with the common drugs Chloroquine and Lopinavir / Ritonavir, the intervention group (PPd (purified protein derivative) is also performed for them in the intervention group. We evaluate and evaluate by an infectious disease specialist through daily tests for patients and CT Scan of the chest on days 0, 3 and 7, and Corona testing on days 7 and 14 for patients to relieve fever
Category
Treatment - Drugs

2

Description
Control group: People with Covid 19 Patients after random registration of personal information including name and surname, gender, age, weight, place of residence, occupation, the presence of underlying diseases and disease profile randomly in one of the two groups tested And control based on AB and BA random block design. They are only routinely treated with chloroquine and Lopinavir / Ritonavir, and are evaluated by an infectious disease specialist through daily tests for patients and CT Scan of the chest on days 0, 3 and 7, and Corona testing on days 7 and 14 for patients, fever relief, face Accept.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Dr.Jalal Karimi
Street address
Jomhori aslami
City
fasa
Province
Fars
Postal code
7461837513
Phone
+98 71 5331 4201
Fax
+98 71 5335 2590
Email
Hadiazizi2323@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Mojtaba Farjam
Street address
Daneshgah
City
fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
FARJAM.MD@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa University of Medical Sciences
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
Fasa University of Medical Sciences
Full name of responsible person
Abdolah Azizi
Position
Head of Non-Communicable Diseases
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Jomhore
City
Fasa
Province
Fars
Postal code
7461837513
Phone
+98 71 5331 4200
Fax
+98 71 5335 2590
Email
hadiazizi2323@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.jalal karimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Jomhori Aslami
City
fasa
Province
Fars
Postal code
7461837513
Phone
+98 71 5335 9600
Email
Jalalmd7@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Abdolah Azizi
Position
Head of Non-Communicable Diseases
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Jomhore
City
Fasa
Province
Fars
Postal code
7461837513
Phone
+98 71 5331 4200
Fax
+98 71 5335 2590
Email
hadiazizi2323@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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