A randomized clinical trial study, comparison of the therapeutic effects of Ivermectin, Kaletra and Chloroquine with Kaletra and Chloroquine in the treatment of patients with coronavirus 2019 (COVID-19)

Clinical trial study of the therapeutic effect of Ivermectin in combination with Kaletra and Chloroquine diet in the treatment of Coronavirus patients in 2019 (COVID-19)

Clinical trial with control group, parallel group trial, double-blinded, phase 2 on 60 patients. Replacement randomization was used.

In both study groups (control and case), on the first day, patients will receive chloroquine at a dose of 200 mg, and from the second day for six consecutive days they will receive Lopinavir / ritonavir (Kaletra) at a dose of 400/100 mg. At the first day, in addition to the above drugs, Ivermectin 200–150 μg/kg, is given.

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 Ivermectin and 3- Patients who have been included in other clinical trial studies

Case group: Get the Ivermectin plus Kaletra plus Chloroquine Control group: Get the Kaletra plus Chloroquine

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.

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 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). In this method, each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes 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.

To reduce bias, the single-blinded method is used, which can be sure the outcome was measured objectively. In this method, the participant does not know which of the two groups of control or test belongs.