Evaluation of the time to clinical recovery in the case with indomethacin in moderate-intensity pneumonia caused by Corona 19 compared with the control group
Design
Randomized single blind, phase 3 clinical trial on 60 patients, The random number table was used for randomization
Settings and conduct
This study was performed in two hospitals, Noor and Amin, in Isfahan, on patients with moderate-intensity pneumonia caused by covid 19.
Participants/Inclusion and exclusion criteria
Inclusion criteria
18- to 75-year-olds with moderate-intensity pneumonia caused by Covid 19 whose disease has been proven on the basis of CT scan or PCR evidence and have signed a participation form.
Exclusion criteria
All people who are prohibited from taking indomethacin or similar compounds or who are likely to have severe side effects if taken indomethacin
Intervention groups
Patients with inclusion criteria in the intervention group, in addition to the usual treatment, are treated daily with indomethacin 75 mg slow-release tablets for 5 consecutive days. In the control group, placebo is added to the usual treatment for covid 19 infection.
Main outcome variables
Time to clinical recovery
14 days readmission Rate
Time to intubation
Intubation rate
28 days survival rate
side effects caused by indomethacin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200427047215N1
Registration date:2020-05-05, 1399/02/16
Registration timing:prospective
Last update:2020-05-05, 1399/02/16
Update count:0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Ali Darakhshandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3777 2640
Email address
alidarakhshandeh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-08, 1399/02/19
Expected recruitment end date
2020-07-09, 1399/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of oral indomethacin for treatment of covid 19 induced pneumonia
Public title
Evaluation effect of Indomethacin for Covid19 infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 75 years old hospitalized
Patient with SpO2:85-89% on room air at admission (if correct with nasal O2 maximum 6 liter/min to SpO2>=90 )
Patients with SpO2: 90-93% and RR>=30
clinical compatible patients with positive RT-PCR test or consistent HRCT to covid19 pneumonia
Sign the study participation form
Exclusion criteria:
Known hypersensitivity to indomethacin or any components of NSAIDs
History of asthma, urticarial, or other allergic type reaction after taking aspirin or NSAIDs
GFR less than 60ml/minute/1.7m2
Patients with active gastrointestinal bleeding
The need for intubation in the first 24 hours of hospitalization
Patients with multi organ failure
Patients with shock state at admission
Pregnant woman
Lactating woman
Patients with active peptic ulcer
Consumption of NSAID on admission
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the random number table method is used for randomization.The randomization unit is also the individual.To read numbers, it is also from left to right.For concealment, the method of sequentially numbered, sealed, opaque envelopes is used.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients, the main researcher, the physician who visits patients daily for response to the treatment and examination of symptoms, and is responsible for collecting information, and the nursing staff are kept blind to the allocation of study groups.All patients are visited daily by one of the physicians of the treatment team who is in the process of intervention.However, the follow-up of the side effects of the drug and the evaluation of the course of treatment in patients will be performed by another physician, who is also in the general study constant.This physician will monitor the condition of patients at home for up to 4 weeks after discharge and will be completely blind.
Placebo
Used
Assignment
Other
Other design features
In this study, patients with admission conditions were divided into two groups. In addition to the usual treatment for coronavirus infection, the intervention group received 75 mg of indomethacin tablets daily for 5 consecutive days, but the control group received routine treatment for corona infection plus placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences
Street address
No 566, 13 Alley, Saadat streat, Janbazan Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174797677
Approval date
2020-04-14, 1399/01/26
Ethics committee reference number
IR.MUI.MED.REC.1399.045
Health conditions studied
1
Description of health condition studied
Pneumonia induced by covid19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Time to clinical recovery
Timepoint
Control clinical signs daily until discharge from the hospital
Method of measurement
Fever control with thermometer, oxygen saturation control with pulsoximetry
2
Description
14 days readmission after discharge.
Timepoint
Up to 14 days after discharge
Method of measurement
All patients will be given a contact number to notify them if they are hospitalized again. All patients will be monitored by phone weekly for up to 4 weeks after the first day they are admitted.
3
Description
Time to intubation
Timepoint
Control of oxygen saturation, respiratory status every 6 hours during hospitalization
Method of measurement
If the patient needs intubation due to reduced oxygen saturation or increased respiration rate, the date of incubation will be recorded on a daily basis from the time of hospitalization.
Secondary outcomes
1
Description
Survival 28 days after hospitalization
Timepoint
From the first day of hospitalization to 28 days after hospitalization
Method of measurement
A questionnaire is used to measure survival. At the time of hospitalization, this questionnaire is completed daily by one of the researchers. After discharge, the patient's condition will be monitored weekly for up to 4 weeks after the first day of hospitalization.
Intervention groups
1
Description
Intervention group:ُُSlow release Indomethacin tablets, 75 mg daily for five days. Made by Aria Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Control group: A placebo similar to indomethacin tablets is given daily for five days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Hospital
Full name of responsible person
Ali Darakhshandeh
Street address
Hasht behesht Ave, Ostandari Ave
City
Isfahan
Province
Isfehan
Postal code
1234567890
Phone
+98 21 3222 2127
Email
nour@mui.ac.ir
Web page address
https://nour.mui.ac.ir/fa/
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Ali Darakhshandeh
Street address
Ebnesina Ave
City
Isfahan
Province
Isfehan
Postal code
1234567890
Phone
+98 31 3445 5051
Fax
Email
amin@mui.ac.ir
Web page address
https://amin.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences Vice Chancellor for Research and Technology
Full name of responsible person
Ali Darakhshandeh
Street address
Hezar Jarib Ave,Isfahan univercity of medical sciences
City
Isfahan
Province
Isfehan
Postal code
73461- 81746
Phone
+98 31 3668 0048
Email
isfahan.med@mui.ac.ir
Web page address
http://med.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences Vice Chancellor for Research and Technology
What processes are involved for a request to access data/document
In case of requesting data for the study, the applicant must first introduce himself or herself and the relevant organization to determine the purpose of the data request and state for what purpose this data is used.After submitting the request, if the researchers of this study prove that the data of this study can advance the therapeutic goals, the information will be sent as long as the data remains confidential.This process takes two weeks.