Evaluation of effectiveness and safety of Doxycycline in combination with standard treatment on clinical improvement and outcome of Covid-19 patients: a clinical trial
Evaluation of safety and effectiveness of doxycycline in the treatment of hospitalized patients with Covid-19
Design
Open label phase 3 clinical trial with a control group and parallel groups on 180 randomized patients; Random Allocation Software was used for randomization.
Settings and conduct
This study will be performed on patients with Covid 19 in Firoozgar Hospital in Tehran and the efficacy of dixycycline in them will be evaluated. Patients in both groups are treated with the standard protocol or dioxycycline, this study is not blinded and the necessary information will be collected using a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age more than 18 years, definitive diagnosis of Covid 19 and having informed consent. Also, exclusion criteria included allergies to dioxycycline, chronic liver failure, chronic renal failure, history of lupus, history of porphyria, pregnancy or breastfeeding.
Intervention groups
Control group: Standard protocol will be used for ten days including daily oxygen with the rate of 5 to 7 liters per minute, observance of hygienic principles and subcutaneous use of heparin manufactured by Caspian Pharmaceutical Company 5000 units three times per day, for 10 days.
Intervention group: In addition to the national standard treatment protocol, doxycycline 200 mg capsules made by Pars Behroozan Company are used initially and then doxycycline 100 mg capsules twice a day for 7 days.
Main outcome variables
need for ICU admission and duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201117049427N1
Registration date:2022-08-08, 1401/05/17
Registration timing:retrospective
Last update:2022-08-08, 1401/05/17
Update count:0
Registration date
2022-08-08, 1401/05/17
Registrant information
Name
elnaz Sarkheyl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5621 3583
Email address
elnazsarkheyl@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness and safety of Doxycycline in combination with standard treatment on clinical improvement and outcome of Covid-19 patients: a clinical trial
Public title
Effect of Doxycycline on clinical improvement and outcome in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age higher than 18 years
Definitive diagnosis of Covid 19
Having informed satisfaction
Exclusion criteria:
Allergy to Doxycycline
Chronic liver disease
Chronic kidney disease
History of lupus
History of porphyria
Pregnancy and lactation
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, computer-aided random assignment method is used. The samples are determined using the random number table in the Random Allocation Software. Blocking and allocation sequence for concealment will be done by a person not involved in the research, the block size is 6. The allocation ratio will be (1:1) and they will be placed in two groups. Then, based on the obtained blocks and in the order of the allocation sequence, the drugs will be given to the patients.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.IUMS.FMD.REC.1399.523
Health conditions studied
1
Description of health condition studied
Covid 19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
Before the intervention and 5 days after the intervention
Method of measurement
Checklist
2
Description
ICU admission
Timepoint
Before the intervention and 5 days after the intervention
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the national standard protocol and supportive therapies, they are treated with doxycycline capsules manufactured by Pars Behroozan company at a dose of 200 mg first day and then 100 mg every 12 hours daily with two glasses of water in a sitting position for 7 days.
Category
Treatment - Drugs
2
Description
Control group: They are treated with standard protocol including daily oxygen with the rate of 5 to 7 liters per minute, observance of hygienic principles and subcutaneous heparin produced by Caspian Pharmaceutical Company, 5000 units three times per day for 10 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Elnaz Sarkheyl
Street address
Firoozgar Hospital, Behafarin Street, Valiasr Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 5537 7131
Email
elnazsarkheyl@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvani
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 5621 3583
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Elnaz Sarkheyl
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Firoozgar Hospital, Behafarin Street, Valiasr Sq., Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 5621 3583
Fax
Email
elnazsarkheyl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elnaz Sarkheyl
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Firoozgar Hospital, Behafarin Street, Valiasr Sq., Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 5621 3583
Fax
Email
elnazsarkheyl@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elnaz Sarkheyl
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Firoozgar Hospital, Behafarin Street, Valiasr Sq., Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 5621 3583
Fax
Email
elnazsarkheyl@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
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