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Study aim
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Effects of Tocilizumab, interferon-gamma and vitamin C on serum ferritin, LDH, CPK, CRP lung tissue, heart, lymphocytes, neutrophils, PCO2, and serological tests.
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Design
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The randomized clinical trial consists of a control group,two parallel groups,non blinded,and phase 2. All the 60 patients are systematically assigned to random groups. Randomization will be conducted by SAS software.
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Settings and conduct
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This clinical trial will be undertaken at Ahar Hospital, in East Azarbaijan Province, Iran, under the supervision of Tabriz University of Medical Sciences. It is approved by the ethics committee of TUOMS. In all patients, the serum levels of ferritin, LDH, CPK,CRP,IL1,IL6,IL18,TNFa should be significantly higher, and pulmonary involvement should be evident in the CT scan. In addition to the routine medication, Group 1 will receive the Tocilizumab Vial. Group 2 will receive interferon-gamma and Vitamin C besides the usual medication, and the control group will receive only the routine medication. All patients will be monitored for two weeks. In the first and last days of treatment, a CT scan will be performed for patients to examine the lungs and heart. Blood samples will also be taken to check blood constituents (neutrophils, lymphocytes, ferritin, ALT, AST, VBG). In the next step, PCO2 will be measured. All of the above steps will be repeated on days 3-7-10, and 14.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Lack of a specific clinical disease, 18 to 65 years of age, no pregnancy, symptoms of cytokine storm,
Exclusion criteria: An underlying illness, under 18 and over 65 years of age, pregnancy
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Intervention groups
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1: Tocilizumab along with routine medications,
2: interferon-gamma and Injectable vitamin C along with routine medications,
3: Only routine medications
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Main outcome variables
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Ferritin serum
LDH
CPK
CRP
IL1,IL6,IL18,TNFa