Evaluation of short-term effects of Celecoxib on clinical improvement of COVID-19 patients: A randomized clinical trial study
Design
Based on the treatment chart and matching of the studied individuals and in order to eliminate any confounding factor, receiving all kinds of main and complementary drugs and also the dose of the drug is referred to the instructions of the Ministry of Health, in treatment for patients with moderate disease. Patients admitted are divided into two general groups. During the treatment period, the variables raised in patients are evaluated.
Settings and conduct
The intervention group receive celecoxib about 100 mg twice daily and full dose of 200 mg twice daily for 7 days in addition to routine treatments. The control group receives only routine treatments.
The income of the disease is divided into two groups: improvement of lung function, lack of progression of symptoms or becoming a severe condition of the disease.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Moderate pulmonary involvement
2. Shortness of breath, chest pain with or without fever
3. SpO2:90-93%
4. Age: 18-65 years
5. Existence of pneumonia
6. Patients with informed consent
Exclusion criteria:
1. Patients under 18 or over 65 years old
2. Severe and advanced disease
3. Shock and critical illness
4. Taking certain medications
5. Pregnancy
6. Chronic diseases
Intervention groups
First/control group: 20 patients receiving routine therapy
Second Group (40 patients receiving routine therapy+celecoxib) is divided into two subgroups (20 people in each group):
A: received dose 200mg/day
B: received dose of 400mg/day
Main outcome variables
1. CT imaging
(Pulmonary infiltration, Peripheral GG, edema)
2. Respiratory factors
(respiratory rate, Blood oxygen saturation, PaO2/FiO2 )
3. Body temperature
4. Improvement of lung function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200907048644N1
Registration date:2020-10-04, 1399/07/13
Registration timing:registered_while_recruiting
Last update:2020-10-04, 1399/07/13
Update count:0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
Roghayeh Sheervalilou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5817
Email address
sheervalilour@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of short-term effects of Celecoxib on clinical improvement of COVID-19 patients: A randomized clinical trial study
Public title
Celecoxib effects on COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects with COVID-19 in the second phase of the disease
Shortness of breath, chest pain with or without fever equal to or greater than 38 'C
Blood oxygen saturation (SpO2) between 90-93%
Adult patients with COVID-19 with moderate pulmonary involvement and hospitalized in the general ward who have been diagnosed and confirmed with coronavirus by conventional diagnostic methods such as sequencing or qRT-PCR and CT (within 48 hours of admission)
Age range of patients between 18-65 years
Existence of pneumonia in lung CT scan with involvement of maximum 3 or 4 lung lobes or less than one third of the volume of each lobe or infection of one or two lobes with larger area
Patients informed consent
Exclusion criteria:
Patients under 18 or over 65 years old
Patients with severe and advanced disease are admitted to the intensive care unit
Participate in another clinical trial
Shock and critical illness (requires ventilator and organ failure)
Patients with organ dysfunction such as renal failure and liver damage, patients with asthma
Taking certain medications such as furosemide or Lasex, lithium, ACE2 inhibitors
Pregnancy
People with medical history such as high blood pressure, autoimmune diseases and ..
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
Blood sample collection and respiratory swap
Randomization (investigator's opinion)
Randomized
Randomization description
Based on previous studies calculating the sample size for interventional studies, 60 adult patients with moderate COVID-19 (hospitalized in the general ward) are randomly divided into two groups by permutation block method. So that the two groups are matched to the variables of age and sex.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Dr. Hesabi
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2020-08-26, 1399/06/05
Ethics committee reference number
IR.ZAUMS.REC.1399.197
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Lung function (Pulmonary infiltration, GGO, Edema)
Timepoint
Every week
Method of measurement
CT Scan
2
Description
Respiratory Rate, SpO2, PaO2/FiO2
Timepoint
Every day
Method of measurement
Physical examination
3
Description
Body Temperature
Timepoint
Every day
Method of measurement
Thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 40 patients receiving routine + celecoxib treatments. This group is divided into two subgroups (20 people in each group):A dose received 200mg / day (in divided doses)B at a dose of 400mg / day (in divided doses)