evaluating the effectiveness of tenofovir + hydroxychloroquine regiment compared to hydroxychloroquine alone in patients with COVID-19 penumonia
Design
A randomized single-blinded superiority clinical trial with two parallel groups will carry out on 86 patients
Settings and conduct
This study will carry out on patients who were admitted to the acute respiratory disease ward of Ardabil Imam Khomeini hospital which is the referral hospital of the Ardabil province.
Participants/Inclusion and exclusion criteria
A total of 86 patients with COVID-19 induced pneumonia who have been diagnosed according to standard confirmatory tests will be enrolled in this study regarding the aforementioned inclusion and exclusion criteria.
Intervention groups
Patients will randomly allocate into two groups. Individuals in the study group will receive tenofovir + hydroxychloroquine, and patients in the control group will be treated just with hydroxychloroquine.
Main outcome variables
Alleviation of symptoms, recovery, and discharge;
Deterioration of symptoms transfer to ICU;
Death.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200421047155N1
Registration date:2020-04-25, 1399/02/06
Registration timing:prospective
Last update:2020-04-25, 1399/02/06
Update count:0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
Sina Parsay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3333 7332
Email address
sinaparsa91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic Effect of Tenofovir and hydroxychloroquine combination therapy compared to chloroquine alone in patients with COVID-19
Public title
Efficacy of tenofovir in covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19 pulmonary infection
Established diagnosis of COVID-19 with RTPCR
Patients older than 18 years
Exclusion criteria:
Reinfection with COVID-19
Pregnancy
Patients with immunodeficiency
Individuals who are reluctant to participate in study
Prior history of allergy to used drugs
Documented history of any other medical condition for which the patient require to use a certain medication routinely.
Creatinin clearance less than 30 mg/min
Oxygen Saturation (SpO2) less than 40%
ICU patients
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient will be randomly allocated into one of the cases or study groups by using the "research randomizer" website facility.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients will remain unaware of in which group (study or control) they are.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Science
Street address
Department of infectious disease, Imam Khomeini Hospital, Ataii Ave.
City
Ardabil
Province
Ardabil
Postal code
5614693361
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.AUMS.REC.1399.051
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
vital signs
Timepoint
daily
Method of measurement
direct physical examination
2
Description
body temperature
Timepoint
daily
Method of measurement
thermometer
3
Description
white blood cell count
Timepoint
daily
Method of measurement
blood sample analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: PO Hydroxychloroquine 200 mg and PO tenofovir 300 mg once a day for 7 days
Category
Treatment - Drugs
2
Description
Control group: PO Hydroxychloroquine 200 mg once a day for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ardabil University of Medical Science