Evaluation of the effectiveness of doxycycline in the treatment of outpatients with Covid-19 referred to Shahid Beheshti Hospital in Hamadan in 2020-2021
Design
This is a non blind randomized clinical trial, in which 88 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
This study is performed in Shahid Beheshti Hospital in Hamadan.In addition to standard treatment, 44 outpatients with suspected Qovid 19 outpatient treatment receive Doxycycline is taken orally for 10 days. 44 outpatients with suspected Qovid 19 control groups receive only standard treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Minimum age 18 and maximum age 80 years,Do not take doxycycline for the last five days, Patients with definitive diagnosis of Covid 19 (RT-PCR) candidate for outpatient treatment with pulmonary involvement score on CT scan equal to or below 8,Patients suspected of Covid-19 based on clinical signs and manifestations of CT scan and laboratory results candidate for outpatient treatment.
Exclusion criteria: Hospitalization, patients with no indications for outpatient treatment based on national protocol, pregnancy, patients with a history of allergic reaction or doxycycline sensitivity, underlying disease.
Intervention groups
44 patients with Covid receive doxycycline capsules at a dose of 100 mg twice daily for 10 days with standard care and medication and in the control group 44 patients receive standard care and medication.
Main outcome variables
Improvement of clinical symptoms, hospitalization, mortality rate and side effects of doxycycline
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N16
Registration date:2021-08-25, 1400/06/03
Registration timing:prospective
Last update:2021-08-25, 1400/06/03
Update count:0
Registration date
2021-08-25, 1400/06/03
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of doxycycline in the treatment of outpatients with Covid-19 .
Public title
Evaluation of the effectiveness of doxycycline in the treatment of outpatients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 18 and maximum age 80 years
Do not take doxycycline for the last five days
Patients with definitive diagnosis of Covid 19 (RT-PCR) candidate for outpatient treatment with pulmonary involvement score on CT scan equal to or below 8
Patients suspected of Covid-19 based on clinical signs and manifestations of CT scan and laboratory results candidate for outpatient treatment.
Exclusion criteria:
Hospitalization
Patients with no indications for outpatient treatment based on national protocol.
pregnancy
Patients with a history of allergic reaction or Doxycycline.
Underlying disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached
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
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-07-10, 1400/04/19
Ethics committee reference number
IR.UMSHA.REC.1400.305
Health conditions studied
1
Description of health condition studied
COVID-19, virus identified
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Improvement of clinical symptoms
Timepoint
Start of study and 3, 7, 14 days after study
Method of measurement
Questionnaire - telephone follow-up and
2
Description
hospitalizations
Timepoint
7 and 14 days after study
Method of measurement
Telephone follow up
3
Description
Mortality rate
Timepoint
7 and 14 days after study
Method of measurement
Telephone follow up
Secondary outcomes
1
Description
Side effects of doxycycline
Timepoint
7 and 14 days after study
Method of measurement
Telephone follow up
Intervention groups
1
Description
Intervention group: Doxycycline capsules are given orally made by Iran Daru Company (Iran) 100 mg twice a day for 10 days along with standard care and medication measures for Covid patients.
Category
Treatment - Drugs
2
Description
Control group: Standard care and medication measures for Covid patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Zohreh Kahramfar
Street address
Hamedan University of Medical Science, Shahid Fahmideh Street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3825 2440
Email
kahramfar@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Sadeghibidar
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Medical Physics
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamdan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
hamid.sadeghibidar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zohreh Kahramfar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hamedan University of Medical Science, Shahid Fahmideh Street,
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
6517838678
Email
kahramfar@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zohreh Kahramfar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hamedan University of Medical Science, Shahid Fahmideh Street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3825 2440
Email
kahramfar@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD