Evaluation of the efficacy of Hydroxyurea administration on blood oxygen saturation of hospitalized COVID-19 patients
Design
Before-after clinical trial, single group, without randomization and blinding
Settings and conduct
This study will be performed on patients with severe COVID-19 hospitalized in Labafinejad patients (Tehran, Iran) in 2022. This study is performed on only one group of patients who all receive hydroxyurea tablets (500 mg three times a day) in addition to the usual COVID-19 treatments according to the national guideline. Peripheral blood oxygen saturation, hemoglobin F levels and blood cell counts are assessed every two days. Finally, the data are statistically analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Laboratory confirmation of Coronavirus disease-19 (COVID-19) virus by reverse transcription- polymerase chain reaction (RT-PCR); White blood cell count less than 2500 million cells per microliter; Absolute neutrophil count less than 1000 million cells per microliter; Platelet count less than 80,000 cells per microliter; more than 50% increase in creatinine compared to the amunts of admission time; Pregnancy; Active hepatitis B or C infections.
Intervention groups
This study is performed on only one group of patients who all receive hydroxyurea tablets (500 mg three times a day) in addition to the usual COVID-19 treatments according to the national guideline.
Main outcome variables
Peripheral blood oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210901052358N2
Registration date:2022-03-08, 1400/12/17
Registration timing:prospective
Last update:2022-03-08, 1400/12/17
Update count:0
Registration date
2022-03-08, 1400/12/17
Registrant information
Name
Amirreza Keyvanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4483 1899
Email address
amirrezakeyvanfar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Hydroxyurea administration on blood oxygen saturation of hospitalized patients with severe COVID-19
Public title
Evaluation of the efficacy of Hydroxyurea administration on blood oxygen saturation of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory confirmation of Coronavirus disease-19 (COVID-19) virus by reverse transcription- polymerase chain reaction (RT-PCR)
Oxygen saturation less than 90%
Respiratory rate more than 24 per minute
More than 50% involvement of the lung parenchyma on CT scan
Exclusion criteria:
White blood cell count less than 2500 million cells per microliter
Absolute neutrophil count less than 1000 million cells per microliter
Platelet count less than 80,000 cells per microliter
More than 50% increase in creatinine compared to the amounts of admission time
Pregnancy
Active hepatitis B or C infections
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
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
Organizational Committee of Ethics in Biomedical Research, Shahid Beheshti University of Medical Sci
Street address
Shahid Beheshti University of medical sciences, Arabi St., Daneshjoo Blvd,. Yaman St,. Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.135
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Peripheral blood oxygen saturation
Timepoint
Every other day after starting treatment (up to a week)
Method of measurement
Pulseoxymeter
2
Description
Hemoglobin F levels
Timepoint
Every other day after starting treatment (up to a week)
Method of measurement
Hemoglobin electrophoresis
3
Description
Blood cell count
Timepoint
Every other day after starting treatment (up to a week)
Method of measurement
Laboratory report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study is performed on only one group of patients who all receive hydroxyurea tablets (500 mg three times a day) in addition to the usual COVID-19 treatments according to the national guideline. Usual treatments include serum therapy, vitamins, supplemental oxygen, and remdesivir (200 mg intravenously for first day and 100 mg daily intravenously for the next 4 days).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad hospital
Full name of responsible person
Amirreza Keyvanfar
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
amirrezakeyvanfar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, No. 2, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?