Evaluation of Hemoperfusion effect in treatment of patients with COVID-19 hospitalized in intensive care unit, Randomized clinical trial

The effect of hemoperfusion in the treatment of patients with Covid-19 disease admitted to the intensive care unit

A randomized, single-blinded clinical trial with a control group and parallel design of 20 patients

This study is a clinical trial in Razi Hospital, Rasht, on critically ill patients with COVID-19 admitted to the ICU. Patients will enter the study after obtaining the informed consent and get randomly in one of the two groups.The Cartridge used for hemoperfusion is Jafron HA 330,number of sessions:3, pump speed of the device:250 to 300,duration of each session:4 hours,interval between sessions:8 to 12 hours.For 14 days, patients in both groups will be monitored daily for vital signs,electrolytes,liver and kidney tests, blood cells, coagulation and inflammatory factors,chest radiographs and possible gastrointestinal complications.Finally, the two groups are compared in terms of treatment effectiveness and possible side effects.Participants and physicians in charge will not be blind,but radiologists,researchers evaluating the research and statistics will be blind.

Inclusion criteria:Patients admitted to the ICU with a clinical diagnosis of Covid-19 with a respiratory rate≥ 30,heart rate≥125,oxygen saturation≤90% ,uncontrollable fevers such asT>39 C,increased inflammatory factors, severe hemodynamic disturbance,involvement of more than two vital organs Exclusion criteria:Thrombocytopenia (Plt ≤20000),pregnancy,acute crisis due to sickle cell anemia, resin sensitivity.

The first group will receive the standard COVID-19 treatment based on the national protocol.The second group will receive the standard COVID-19 treatment along with 3 sessions of hemoperfusion according to the protocol provided by the Ministry of Health.

Improving the patient's clinical condition

In this study, patients will enter each of the two treatment groups randomly using a 1: 1 block randomization method. Twenty patients with a diagnosis of Covid 19 will be divided into 2 groups of 10 intervention and control. The hemoperfusion group is called A and the control group is called B.Random blocking will be done in such a way that the research units are assigned numbers 1-20, respectively. Then a table with 6 rows called blocks and each block will have 4 parts and each part will be named with A and B, will be considered. In the next step, the numbers will be placed in each house in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the hemoperfusion method and the people who had the number in house B will be considered the control group. The website https://www.sealedenvelope.com is used for randomization. For hiding, the Allocation concealment method will be used. So that before the individual is assigned, the assigned group is not specified. In this method, using the same sealed envelopes, with a random sequence in which each of the random sequences created on this card is recorded and the cards inside the envelopes will be placed in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. At the beginning of the registration of eligible patients, one of the envelopes will be opened and the patient will be a candidate for hemoperfusion or control group.

Participants and health care providers responsible for patients' health will not go blind and are informed about the therapy groups . Radiologists, researchers evaluating the research and statistical expertise will be blind. Sequentially numbered opaque, sealed envelopes: Envelopes method is used to hide random allocation.