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Evaluation of the protective effect of a combination drug including Apocynin, Niacin, and Tannin on prevention of cardiovascular and respiratory morbidities and mortality in COVID-19 infection: A Clinical Trial

Protocol summary

Study aim
To evaluate the respiratory and cardiovascular morbidities in the experimental group with daily consumption of Tannin-Niacin-apocynin in affected patients by coronavirus infection
Design
In phase II, at first, 5 patients with non-serious presentations are included in a pilot-study with informed consent. The current-treatments are given to the patients in an open-labeled-approach and the combination drug is added on their treatment. If the results are approved the trial will continue with more patients up to 20% of all experimental-cases. If the results are approved again, the study will continue on all the cases according to the following statement.
Settings and conduct
80 patients confirmed for COVID-19 are recruited into two groups through the permuted block randomization approach. Each group included 40 cases.
Participants/Inclusion and exclusion criteria
Inclusion-criteria: Age more than 18 years, Clinical and paraclinical signs and symptoms for COVID19, inpatient-setting, Positive-PCR, Informed-consent Exclusion-criteria: Pregnancy, hx of using ACEI and ARB-drugs, fludrocortisone, spironolactone, eplerenone, TCA, Simvastatin, MAO-inhibitors, serotonin-inhibitors, Triptamins, Alcoholism, Heart-Failure, Hepatic-Failure, renal-dysfunction, drug side-effects, Active-peptic-ulcer, Active-Bleeding
Intervention groups
Experimental group includes inpatient COVID19cases with mild-to-moderate respiratory problems that are confirmed for corona infection. They give current treatment plus the three-drug combination of trial. Control group includes the COVID19patients with mild-to-moderate respiratory problems that will be treated just by current-treatment.
Main outcome variables
Primary outcomes: Fever, PR, RR, BP Dyspnea O2 sat ICU dependency Ventilation-dependency inpatient-period Mortality Secondary outcomes: 28days-survival Re-hospitalization Clinical symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200418047122N1
Registration date: 2020-05-03, 1399/02/14
Registration timing: registered_while_recruiting

Last update: 2020-05-03, 1399/02/14
Update count: 0
Registration date
2020-05-03, 1399/02/14
Registrant information
Name
Mehrdad Zeinalian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9196
Email address
m.zeinalian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-25, 1399/02/06
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the protective effect of a combination drug including Apocynin, Niacin, and Tannin on prevention of cardiovascular and respiratory morbidities and mortality in COVID-19 infection: A Clinical Trial
Public title
Evaluation of the therapeutic effect of a combination drug including Apocynin, Niacin, and Tannin on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years Clinical and paraclinical signs and symptoms for COVID19-induced pneumonia inpatient setting Positive PCR for COVID19 Informed consent
Exclusion criteria:
Pregnancy A recent medical history of using ACEI and ARB drugs, fludrocortisone, spironolactone, eplerenone, TCA antidepressant, Simvastatin, MAO inhibitors, serotonin inhibitors such as sertraline and citalopram, Triptamins, Alcoholism Heart Failure (EF<25%) Hepatic failure (Child Pugh score ≥ C ,AST> 5 times of the upper limit normal) Severe renal dysfunction (GFR less than 30cc per min) Any drug side-effects including: Patients’ intolerance, Diarrhea, Gastrointestinal problems Active peptic ulcer Active Bleeding
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Altogether, 80 patients confirmed for COVID-19 are recruited into two groups through permuted block randomization approach. The block size will be considered of size 4. Each group included 40 cases and 40 controls.
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
Institutional Research Ethics Committee, School of Medicine, Isfahan University of Medical Sciences
Street address
School of Medicine, Isfahan University of Medical Sciences, Hezar-Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.MUI.MED.REC.1399.050

Health conditions studied

1

Description of health condition studied
COVID-19-induced pneumonia
ICD-10 code
U07.01
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Fever
Timepoint
BID
Method of measurement
Thermometer

2

Description
Hemodynamic signs
Timepoint
BID
Method of measurement
P/E

3

Description
O2 sat
Timepoint
BID
Method of measurement
Puls-Oximetery

4

Description
Clinical symptomes
Timepoint
TDS
Method of measurement
P/E and medical hx

Secondary outcomes

1

Description
Drug side-effects
Timepoint
Continuous
Method of measurement
PE and MH

2

Description
Survival and clinical symptoms
Timepoint
Continuous
Method of measurement
PE and MH

Intervention groups

1

Description
Intervention group: This group includes inpatient cases with mild to moderate respiratory problems that are confirmed for corona infection. In phase II non-randomized clinical trial, at first, 5 patients confirmed with COVID-19 and non-serious presentations are included in a pilot study from which informed consents have been gotten. The current standard treatments are given to the patients in an open-labeled approach and combinative drug including: two capsules and two spoonfuls of syrup per day including Niacin-Tannin in capsule and Apocynin in syrup with Bid consumption of Tannin(125mg) + Niacin(5mg) and one spoonful apocynin (2.5mg) up to 14 days. The control group only receives current treatment. . Then the side-effects and efficacies will be evaluated. If no side-effects are observed and therapeutic outcomes are positive, the results will be reported to the RCT assessment committee. If the permission is given, the trial will continue with more patients up to 20% of all experimental cases. Then the evaluation will be repeated. If the results are approved again, the study will continue on all the cases according to the following statement. In this clinical trial we will finally recruit 80 patients infected by COVID19 in two groups of experimental and control. Except in the pilot phase that the control group is not included, in the following, the control group will be also added with just standard treatment until 14 days follow-up and clinical assessment. If a patient is discharged from the hospital, his/her follow-up of the treatment and clinical evaluation will continue at home via daily interview by phone. The necessary education will be presented for all the patients and their families before discharging.
Category
Treatment - Drugs

2

Description
Control group: This group includes the patients with mild to moderate respiratory problems that are confirmed for Corona infection
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Dr Pourajam
Street address
Ebne-Sina Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 5055
Email
spourajam@gmail.com

2

Recruitment center
Name of recruitment center
Noor Hospital
Full name of responsible person
Dr Shirani
Street address
Bagh-Goldasteh Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2127
Email
zeinalianmehrdad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Tahereh Changiz
Street address
Hezar-Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 9196
Email
zeinalianmehrdad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Hossein Khanahmad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 9197
Email
hossein_khanahmad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Hossein Khanahmad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Hezar-Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 9197
Email
hossein_khanahmad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehrdad Zeinalian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Hezar-Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 9196
Email
zeinalianmehrdad@gmail.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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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