Reduction of viral load and inflammatory cytokines in patients with covid19
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2.3 on 60 patients. Www.sealedenvelope.com was used for randomization.
Settings and conduct
in this study, 60 patients with coronavirus hospitalized in Ali Asghar Hospital in Shiraz who are eligible for inclusion in the study are randomly assigned to one of the three groups of Desferal + Zinc,Zinc and placebo.
Dosing: 2 puffs every eight hours for a week
In this study, the patients, the physician evaluating the patients, and the person analyzing the statistical inform, are blind.
Participants/Inclusion and exclusion criteria
Major inclusion criteria before randomization:
Informed and written consent of patient with Coronavirus،
Confirmation disease by clinical and laboratory signs،
Patients admitted to the ward with moderate symptoms ،
18 to 65 years
Major exclusion criteria to study before randomization:
Pregnancy and Breastfeeding،
concomitant use of vitamin C،
Intubated patient،
History of Desferal or Zinc allergy
Intervention groups
1-Nasal spray Desferal + Zinc,chemical ingredients: desferrioxamine (500mg) plus Zinc acetate (200 mg) in a volume of 10 cc.
2-Nasal spray Zinc,chemical ingredients: Zinc acetate (200 mg) in a volume of 10 cc
3-control group:Nasal spray containing 10 cc of distilled water.
Dosing: 2 Puffs in the nose every eight hours for a week
Main outcome variables
Interleukin 6,
Body temperature,
Cough,
Oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210519051348N1
Registration date:2021-10-31, 1400/08/09
Registration timing:registered_while_recruiting
Last update:2021-10-31, 1400/08/09
Update count:0
Registration date
2021-10-31, 1400/08/09
Registrant information
Name
Navid Esmaeilzadehshahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2631 4813
Email address
esmaeilzadeh_n@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of Desferal + Zinc nasal spray to improve clinical and pulmonary symptoms in patients with COVID-19
Public title
Evaluation of safety and efficacy of Desferal + Zinc nasal spray
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and written consent of patient with Coronavirus Confirmation disease by clinical and laboratory signs Serum creatinine less than two Milligram per Deciliter Absence of heart problems( myocarditis- heart failure ) Hemoglobin above 8 Gram per Deciliter Patients admitted to the ward with moderate symptoms 18 to 65 years
Exclusion criteria:
Ferritin lower than 100 milligram per deciliter Diabetes History of blood coagulation problems Pregnancy and Breastfeeding History of neurologic problems History of vision and hearing problems concomitant use of vitamin C Intubated patient History of Desferal or Zinc allergy
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be performed (each block includes 6 patients).
Dedicated sequences and hidden codes using www.sealedenvelope.com
are produced.
The closed envelope method will be used to hide the allocation sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients participating in the study as well as the clinician evaluating the patient and the person analyzing the data were kept blind and the researcher was aware of the drug and placebo recipients. To perform blinding during randomization using the site www.sealedenvelope.com, by activating the generate uniqe ramdimization code option, each patient will be given a special code that will be written on the medicine containers and all the containers will be exactly the same. And these codes remain confidential with the researcher until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Karimkhanzand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2021-09-12, 1400/06/21
Ethics committee reference number
IR.SUMS.REC.1400.497
Health conditions studied
1
Description of health condition studied
covid19
ICD-10 code
U07.1
ICD-10 code description
COVID19, virus identified
Primary outcomes
1
Description
Interleukin6
Timepoint
Before and after the intervention
Method of measurement
ELISA KIT
2
Description
Body temperature
Timepoint
Before the intervention and every day during the study
Method of measurement
Thermometer
3
Description
Oxygen saturation
Timepoint
Before the intervention and every day during the study
Method of measurement
Pulse oximeter
4
Description
Cough
Timepoint
Before the intervention and every day during the study
Method of measurement
questionnaire
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Admission period until hospital discharge
Method of measurement
Patient file
2
Description
Incidence of serious adverse events
Timepoint
Before intervention and daily during the study
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: Nasal spray Desferal + Zinc,chemical ingredients: desferrioxamine (500mg) plus Zinc acetate (200 mg) in a volume of 10 cc.Dosing: 2 Puffs in the nose every eight hours for a week
Category
Treatment - Drugs
2
Description
Intervention group2: Nasal spray Zinc,chemical ingredients: Zinc acetate (200 mg) in a volume of 10 cc Dosing: 2 Puffs in the nose every eight hours for a week
Category
Treatment - Drugs
3
Description
Control group: Distilled water spray in a volume of 10 cc Dosing: 2 Puffs in the nose every eight hours for a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Dr.Farhad Chobdar
Street address
Meshkinfam Ave
City
Shiraz
Province
Fars
Postal code
71439-18796
Phone
+98 71 3228 8907
Email
aliasghar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.mehrzad Lotfi
Street address
Karimkhanzand Ave
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Navid Esmaeilzadeh Shahri
Position
Resident of Clinical Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Ferdowsi Ave.
City
Shiraz
Province
Fars
Postal code
۷۱۳۵۷۶۵۷۴۸
Phone
+98 71 3231 5156
Email
esmaeilzadeh_n@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
laleh mahmoudi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Akbarabad Ave.
City
Shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Phone
+98 71 3242 4127
Email
mahmoudi_l@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra EbrahimiBidgoli
Position
Student of pharmacy
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Abiverdi3 Ave.
City
Shiraz
Province
Fars
Postal code
7194763309
Phone
+98 71 3626 8360
Email
zhraabrahymy27@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcomes studied can be shared.
When the data will become available and for how long
The data will be available after the publication of all the obtained results.
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The study or proposal protocol must be approved by the Ethics Committee of the institution or university. The rights of authors and their sponsors must be protected.
From where data/document is obtainable
Shiraz School of Pharmacy to the email address pharmacyfaculty@sums.ac.ir and contact number 00987132424128
Dr. Laleh Mahmoudi to the email address mahmoudi_l@sums.ac.ir and the contact number 00989126135992
What processes are involved for a request to access data/document
Requests should be addressed to the Technology and Research Vice-chancellery of Shiraz University of Medical Sciences and the project executor should informed.After submitting the application, a maximum of one week will be answered .