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IRCT20200422047168N1 IRCT 2020-04-29 Ahvaz University of Medical Sciences Clinical trial study on the therapeutic effect of Tenofovir besides routine drug regime (standard of care) in patients with Coronavirus disease 2019 (COVID-19) Ahvaz TAF study Comparison of the Effectiveness of Tenofovir antiviral drug beside routine drug regime (standard of care) in COVID-19 patients 2020-04-18 anticipated 60 Complete https://irct.ir/trial/47437 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 2-3 covid-19. Intervention 1: 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. Intervention 2: Control group: On the first day, patients will receive routine drug regime (standard of care) for 7 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no answer
public Zahra Shokati
Alimentary Tract Research Center Imam Khomeini Hospital Ahvaz Jundishapur University of Medical Sciences Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 6163837194 +98 61 3333 5678 zahrashokati@gmail.com Ahvaz University of Medical Sciences scientific Zahra Shokati
Alimentary Tract Research Center Imam Khomeini Hospital Ahvaz Jundishapur University of Medical Sciences Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 6163837194 +98 61 3333 5678 zahrashokati@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 1- History of renal failure, 2- Taking drugs that interfere with Tenofovir 3. Patients who have been admitted to other clinical trials U07.1 Covid-19, confirmed cases, positive test result Treatment - Drugs Treatment - Drugs 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. Control group: On the first day, patients will receive routine drug regime (standard of care) for 7 days. Reduce the mortality rate of patients with Covid-19. Timepoint: days 0-7. Method of measurement: Based on the percentage of discharged Covid-19 patients. Treatment period. Timepoint: 0-7. Method of measurement: Based on the days numbers of the drug usage. Duration of infection. Timepoint: 0-7. Method of measurement: Based on the patient's clinical symptoms. Duration of admission time. Timepoint: 0-7. Method of measurement: Number of admission days due to Covid-19. Duration of ICU admission time. Timepoint: 0-7. Method of measurement: Number of ICU admission days due to Covid-19. Fever. Timepoint: 0-7. Method of measurement: Rising body temperature. Blood oxygen saturation percentage. Timepoint: 0-7. Method of measurement: O2 saturation percentage. Respiratory rate. Timepoint: 0-7. Method of measurement: respiratory rate per minute. Heart rate. Timepoint: 0-7. Method of measurement: heart rate per minute. Discharge situation. Timepoint: 0-7. Method of measurement: Alive or dead. Use non-invasive respiratory methods. Timepoint: 0-7. Method of measurement: Patients percentage that be supported by non-invasive breathing methods. Use invasive respiratory methods. Timepoint: 0-7. Method of measurement: Patients percentage that be supported by invasive breathing methods. Ahvaz University of Medical Sciences Approved 2020-04-18 Ethics committee of Jundishapur University of Medical Sciences Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)