Evaluation of the effects of alpha-1-antitrypsin on the progression of covid-19 disease: a randomized control trial

In this research, we aim to present the potential role of AAT as an anti-viral and anti-inflammatory agent in SARS-CoV-2 infection.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. It is used for randomization with blocking based on alpha-1-antitrypsin serum level and random numbers.

Coronary patients admitted to the ICU of hospitals affiliated to Shahid Beheshti University of Medical Sciences will be evaluated. The present study will be a double-blind randomized controlled clinical trial with parallel groups. The research population is 50 patients. The duration of the study is four weeks and the intervention is weekly. The dose used is 60mg/kgBW and it is an injectable drug. The patient, researcher and health care provider will be blinded. For this purpose, a placebo with the appearance of the drug is used.

People who are willing to participate in the research, over 18 years of age, with a positive PCR test for corona or lung involvement in imaging, with oxygen saturation less than 93% in room air, or RR>40 with or without fever. Patients suffering from underlying diseases are not included in the study. People who use anti-coagulant drugs, hormonal drugs, and other illegal drugs, or who consume alcohol, are pregnant or lactating, are not included in the study.

The intervention group received alpha-1-antitrypsin and the control group received placebo (normal saline 0.9%).

The level of serum alpha-1 antitrypsin, the number of neutrophils and lymphocytes, Mortality rate and hospitalization time, the ratio of neutrophils to lymphocytes, and the serum protein levels of CRP, ESR, interleukin 6, IgA, and anti-IgA antibody.

The participants were divided into two groups based on the level of AAT serum by Stratified Blocked Randomization. a random sequence will generate. For this purpose, we will use random sequence generation software. We will calculate random sequences in the range of 1-2 using the stat trek software (https://stattrek.com/statistics/random-number-generator.aspx) for two groups one and two (for example: 2 1 1 2 1 2 1 1 2 2 1 1 2 1 2 2 2 1 1 2 1 2 1 ...........). The numbers 1 are assigned to the intervention group 1 (alpha-1-antitrypsin) and the numbers 2 are assigned to the control group. Each number will represent a group according to the defined numbers. With this method, at the end, we will have a specific sequence of codes 1 and 2, which shows the blocks who are going to be included in the study, in which group they should be placed. We wrote the codes on a piece of paper and put them in an envelope to use during sampling. In this way, after checking the entry criteria and if the client wishes, we will enter each block entered into the study into the groups according to our predetermined list.

In order to blind the patient, the researcher and the clinical caregiver, the alpha-1-antitrypsin and placebo will be used that have the same appearance, but the patient, the researcher and the health care provider will not be informed that each person is using the alpha-1-antitrypsin or the placebo.