COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Control group: Patients in this group receive a placebo at a dose of 8 mg/kg (up to a maximum dose of 800 mg/kg) by two consecutive intravenous infusions 12 hours apart in addition to
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men and women of at least 18 years of age capable of providing informed consent. Confirmation of COVID-19 with RT-PCR. Need for hospitalization. No need for mechanical ventilation. No need to more than 10 L/min of supplemental oxygen by any device. Being in a severe COVID-19 phase (at least 2 of the following): Fever > 38 ° C in the last 72 hours, Evidence of pulmonary involvement on chest x-ray (50% progression in the last 48 hours), Dependence on supplemental oxygen to maintain a blood oxygen saturation > 90% Having at least one of the following: CRP > 50 mg/L, LDH > 350 U/L, D-Dimer > 1000 ng/mL
Exclusion criteria
Exclusion criteria: Patients more than 70 years of age with a history of any of the following in the last six months: Class III / IV Heart Failure Based on the New York Heart Association (NYHA) classification, Insulin-dependent diabetes, Angina pectoris, Malignancy Uncontrolled bacterial, fungal, or viral infection (other than COVID-19). Active TB Any history of any progressive neuromuscular disease. Any previous history of treatment with immunosuppressive medications in the last 28 days. Concomitant use of any immunosuppressive drug that puts the patient at greater clinical risk. Any history of allergy to Tocilizumab. Any history of receiving convalescent plasma therapy Any history of intestinal diverticulitis or perforation Absolute neutrophil count (ANC) 5 times the upper limits of normal Pregnant women or those intending to become pregnant in the next 90 days Breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from the administration of the agent or placebo to the need for mechanical ventilation and intubation or death for whom died before intubation (within 28 days). Timepoint: 4, 7, 14, 21 and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time since prescribing the investigated agent or placebo to the deterioration of patient status for one degree (for patients with a score of = 3 on the clinical improvement scale at the time of enrollment) or two degrees (for patients with a score = 2 on the clinical improvement scale at the time of enrollment). Timepoint: 4, 7, 14, 21, and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team.;Time since the administration of the study agent or placebo to when the patients with a score of = 3 on the clinical improvement scale at the time of enrollment do not require oxygen supplementation (within 28 days). Timepoint: 4, 7, 14, 21, and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Barary
Babol University of Medical Sciences
Outcome results
None listed