COVID-19 trials registries data warehouse

http://en.irct.ir/trial/56613

Reza Ghadimi

rezaghadimi@yahoo.com

2021-06-04

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

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) < 500 or platelets < 50,000 AST or ALT > 5 times the upper limits of normal Pregnant women or those intending to become pregnant in the next 90 days Breastfeeding women

2

Babol University of Medical Sciences

18

100

Iran

Severe disease at enrollment

6: Severe disease at enrollment

60

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).

Phase 3

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]