Comparison of the Effectiveness of Tenofovir antiviral drug beside routine drug regime (standard of care) in COVID-19 patients

Comparison of the Effectiveness of Tenofovir antiviral drug beside routine drug regime (standard of care) in COVID-19 patients

Clinical trial with control group, parallel group trial, open lable, phase 2 on 60 patients. Replacement randomization was used.

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.

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

Case group: Get the Tenofovir + standard of care Control group: Get the standard of care

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.

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.

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.