COVID-19. COVID-19
Conditions
Interventions
Intervention group: Subcutaneous (two PFS injections of 162 mg Tocilizumab for ?patients 100 kg) in addition to the standard treatment. In case of inadequate response, Tocilizumab would be re-administ
Sponsors
Aryogen Pharmed
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ?Ability to comprehend and willingness to sign the informed consent form for this study by ?the patient or his/her guardian Patients above 18 years old? Patients with fever higher than 37.8 °C, cough, shortness of breath, or respiratory rate higher than 30 breaths/min accompanied by SpO2 = %93, who ?have a confirmed diagnosis of SARS-CoV-2 infection using PCR and/or radiography.? Serum Interleukin-6 level = 3 times upper limit of normal
Exclusion criteria
Exclusion criteria: History of hypersensitivity to Tocilizumab or any components of the formulation Hepatic disease (especially active hepatic diseases and hepatic impairment)? Patients with bone marrow suppression (defined as Absolute Neutrophil Count (ANC) below 2000/mm3 ?or platelet count below 100,000/mm3)? Patients with a high risk of gastrointestinal perforation or with distinct history of GI disorders, e.g., active peptic ulcer and diverticulitis ? Patients with active or latent tuberculosis ? ?Patients with history of active hepatitis B, hepatitis C, HIV, or any known immunodeficiency Pregnant or lactating patients Patients with any other active infection in addition to COVID-19 Patients with any other disease or disorder, which, in the opinion of the investigator will put the subject at risk, ?if they are enrolled Renal impairment (GFR of below 30ml/min/1.73m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality rate during the study (date and cause of death, if applicable). Timepoint: day 1 through 14. Method of measurement: Physical Examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients with improvement in oxygenation. Timepoint: day 1 through 14. Method of measurement: Percent of patients with at least one step decrease in oxygenation supply; steps: 1. no need for supplemental oxygenation; 2. nasal catheter oxygen inhalation; 3. Mask oxygen inhalation; 4. Noninvasive ventilator oxygen supply; 5. Invasive ventilator oxygen supply.;Duration (days) of hospitalization. Timepoint: day 1 thorough 14. Method of measurement: Clinical Evaluation.;Changes in body temperature. Timepoint: Day 1 through 14. Method of measurement: Physical Examination.;The lesions of the pulmonary segment numbers involved in pulmonary CT. Timepoint: Day 1 and 14. Method of measurement: CT scan.;Duration (days) of mechanical ventilation. Timepoint: Day 1 through 14. Method of measurement: Clinical Evaluation.;Changes in C-reactive protein blood level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test.;Changes in Interleukin-6 blood levels. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test.;Changes in White Blood Cell count. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test.;Changes in cholesterol level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test.;Changes in Aspartate transaminase level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test.;Changes in Alanine transaminase level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test.;Injection site reaction. Timepoint: Day 1 through 14. Method of measurement: Clinical evaluation.;Gastrointestinal perforation. Timepoint: Day 1 through 14. Method of measurement: Clinical evaluation; radiographic imaging in case of clinical symptoms.;Infection. Timepoint: Day 1 through 14. Method of measurement: Clinical evaluation, laboratory test, imaging.;Changes in Platelet level. Timepoint: Day 1 through 14. Method of measurement: Laboratory Test.;Changes in bilirubin level. Timepoint: Day 1 through 14. Method of measur | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
OrchidPharmed Co.
Outcome results
None listed