Protocol summary
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Study aim
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Comparison of the Effectiveness of Tenofovir antiviral drug beside routine drug regime (standard of care) in COVID-19 patients
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Design
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Clinical trial with control group, parallel group trial, open lable, phase 2 on 60 patients. Replacement randomization was used.
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Settings and conduct
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In both study groups (control and case), on the first day, patients will receive routine drug regime (standard of care). In addition to the above drugs Alfamed Tenofovir, Case is given daily at 25 mg daily for 7 days.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1. People over 18 years of age. 2. Positive Real-time PCR test for SARS-CoV-2 virus positive after sampling (nasopharyngeal and oropharyngeal swab samples). 3. Pneumonic manifestations of the virus. In CT scans of the lungs, they should be clearly visible, with a 4% lower O2 Saturation of 93%
exclusion criteria: 1- History of renal failure, 2- Taking drugs that interfere with Tenofovir and 3- Patients who have been included in other clinical trial studies
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Intervention groups
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Case group: Get the Tenofovir + standard of care
Control group: Get the standard of care
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Main outcome variables
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Reduce the length of admission time, Reduce the length of ICU admission time, preventing the progression of the disease to acute respiratory distress syndrome (ARDS), Reducing fever, increasing oxygen saturation, Reducing dyspnea, Reducing Respiratory rate, Decreased heart rate.
General information
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Reason for update
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The standard of care regimens approved by the Ministry of Health differed from the time of the trial at the time of registration. Also, the study method was changed from a double blinding study to an open-label study.
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Acronym
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Ahvaz TAF study
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IRCT registration information
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IRCT registration number:
IRCT20200422047168N1
Registration date:
2020-04-29, 1399/02/10
Registration timing:
registered_while_recruiting
Last update:
2022-02-19, 1400/11/30
Update count:
1
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Registration date
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2020-04-29, 1399/02/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-18, 1399/01/30
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Expected recruitment end date
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2021-01-19, 1399/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the Effectiveness of Tenofovir antiviral drug beside routine drug regime (standard of care) in COVID-19 patients
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Public title
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Clinical trial study on the therapeutic effect of Tenofovir besides routine drug regime (standard of care) in patients with Coronavirus disease 2019 (COVID-19)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1- People over 18 years of age,
2- Real-time PCR positive test result for SARS-CoV-2 virus was positive after sampling (nasopharynx and oropharynx swab samples).
3. The manifestations of pneumonia caused by the virus in CT scans of their lungs are quite obvious.
4- They have 93% or lower O2 Saturation percentage
Exclusion criteria:
1- History of renal failure,
2- Taking drugs that interfere with Tenofovir
3. Patients who have been admitted to other clinical trials
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, we will use the Restricted randomization method of block randomization. Blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group).
Random allocation software software is also used to randomize random sequence production software (Random allocation software).
To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-18, 1399/01/30
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Ethics committee reference number
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IR.AJUMS.REC.1399.082
Health conditions studied
1
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Description of health condition studied
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covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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Covid-19, confirmed cases, positive test result
Primary outcomes
1
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Description
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Reduce the mortality rate of patients with Covid-19
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Timepoint
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days 0-7
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Method of measurement
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Based on the percentage of discharged Covid-19 patients
Secondary outcomes
1
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Description
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Treatment period
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Timepoint
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0-7
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Method of measurement
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Based on the days numbers of the drug usage
2
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Description
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Duration of infection
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Timepoint
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0-7
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Method of measurement
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Based on the patient's clinical symptoms
3
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Description
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Duration of admission time
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Timepoint
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0-7
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Method of measurement
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Number of admission days due to Covid-19
4
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Description
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Duration of ICU admission time
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Timepoint
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0-7
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Method of measurement
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Number of ICU admission days due to Covid-19
5
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Description
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Fever
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Timepoint
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0-7
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Method of measurement
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Rising body temperature
6
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Description
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Blood oxygen saturation percentage
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Timepoint
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0-7
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Method of measurement
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O2 saturation percentage
7
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Description
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Respiratory rate
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Timepoint
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0-7
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Method of measurement
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respiratory rate per minute
8
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Description
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heart rate
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Timepoint
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0-7
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Method of measurement
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heart rate per minute
9
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Description
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Discharge situation
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Timepoint
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0-7
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Method of measurement
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Alive or dead
10
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Description
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Use non-invasive respiratory methods
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Timepoint
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0-7
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Method of measurement
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Patients percentage that be supported by non-invasive breathing methods
11
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Description
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Use invasive respiratory methods
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Timepoint
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0-7
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Method of measurement
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Patients percentage that be supported by invasive breathing methods
Intervention groups
1
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Description
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Intervention group: On the first day, patients will receive routine drug regime (standard of care) daily for 7 days. In addition to the above drugs, Alfamed Tenofovir is given to 25 mg daily for 7 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: On the first day, patients will receive routine drug regime (standard of care) for 7 days.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available