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Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19

Protocol summary

Study aim
Investigating the efficacy of Provita Capsule in controlling symptoms in patients with COVID-19
Design
This study is a single-center, prospective, randomized, double-blinded, placebo-controlled, parallel phase 3 clinical trial.
Settings and conduct
Patients who is admitted to Baqiyatallah hospital, and is met the inclusion criteria, will be participated to the study and randomly be assigned into intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms. Exclusion criteria: History of allergy to the ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unit; Pregnancy; Lactation; Impossibility of oral nutrition;
Intervention groups
Intervention group: Provita Capsule, 1 cap., every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Control group: Placebo Capsule, 1 cap., every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.)
Main outcome variables
Clinical symptoms changes (dry cough, respiratory distress, fever)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001165N60
Registration date: 2020-05-28, 1399/03/08
Registration timing: registered_while_recruiting

Last update: 2020-05-28, 1399/03/08
Update count: 0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-14, 1399/02/25
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19
Public title
Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: equal or more than 18 years; The patient have written consciously and freely consent to participate in the study; The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to the ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unit; Pregnancy; Lactation. Impossibility of oral nutrition;
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
this is a double-blinded clinical trial, in which, a completely similar placebo to the drug is given to the main researcher by the manufacturer, and the drug and the placebo are distinguished only by the code that only the original researcher knows about. The doctor and the patient will be unaware of the drug/placebo product. The results will be recorded in the checklist based on the code registered on the drug and the analysis will be done based on the codes. At the end of the study, the meaning of each code will be determined.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah Medical Sciences University
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۷۱
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.BMSU.REC.1399.124

Health conditions studied

1

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

Primary outcomes

1

Description
Clinical symptoms (dry cough)
Timepoint
Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded.
Method of measurement
Physical examination,questionnaire

2

Description
Clinical symptoms (respiratory distress)
Timepoint
Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded.
Method of measurement
Pulse-oxymetery device

3

Description
Clinical symptoms (fever)
Timepoint
Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded.
Method of measurement
Thermometer

Secondary outcomes

1

Description
Ferritin level
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
Blood sample, laboratory analysis

2

Description
Serum level of Interleukin 6
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
Elisa kit

3

Description
Serum level of tumor necrosis factor(TNF) alfa
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
Elisa kit

4

Description
Serum level of Monocyte chemoattractant protein-1(MCP-1)
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
Elisa kit

5

Description
Quality of life
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
The 36-Item Short Form Survey (SF-36) questionnaire

6

Description
Mood
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
Profile of Mood States(POMS) questionnaire

7

Description
Anxiety
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
Perceived Stress Scale (PSS) questionnaire

8

Description
C-reactive protein (CRP) level
Timepoint
Before the intervention initiation (baseline) and day 90's results will recorded on designed checklist.
Method of measurement
Blood sample, laboratory analysis

Intervention groups

1

Description
Intervention group: Provita Capsule (each capsule contain vitamin A, E, D, C, B family, Zn, Se, Para-biotic, and inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran) 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus).
Category
Treatment - Drugs

2

Description
Control group: Placebo Capsule(contain inactive ingredients similar to Provita's inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran), 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Mostafa Ghanei
Street address
Baqiyatallah hospital, Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
mghaneister@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhosein Alishiri
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
80
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

2

Sponsor
Name of organization / entity
Takgen company
Full name of responsible person
Maryam Tajabadi
Street address
4th Floor, No. 214, East Nosrat St.,Towhid Sq. Tehran
City
Tehran
Province
Tehran
Postal code
1419735631
Phone
+98 21 5475 1000
Email
info@takgene.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Baqiyatallah University of Medical Science
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Hasan Saadat
Position
Assistant of Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
saadat350@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Critical Care Pharmacotherapy
Street address
Baqiyatallah university of medical science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
Yunespanahi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Kianpour
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
Pharmacy faculty, Tehran University of medical science, 16-Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Email
parisa_kianpour@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
Undecided - It is not yet known if there will be a plan to make this available
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