Tocilizumab Treatment in Patients With COVID-19

Conditions

• Sars-CoV2

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Accepted

Interventions

• Tocilizumab 20 MG/ML — DRUG
  We study the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection.

Study Details

A phase II clinical trial will be carried out with the objective of studying the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the high mortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will not be included. Patients will be recruited by signing an informed consent and the baseline variables of interest will be recorded. Tocilizumab will be administered in one or two doses, depending on the case, and will be followed up for 30 days. The response to treatment, survival and evolution will be studied. Factors associated with improvement of ARDS and survival will be identified through multivariate analyzes. The results will be compared with those reported internationally.

Key Dates

Start date

Jun 1, 2020

Status verified

Apr 2026

Primary completion

Dec 1, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab tratment
  Tocilizumab (RoActembra). Vials of 20 ml with 400 mg (20mg/ml) and 4ml with 80 mg (20mg/ml). A singe 60-minute IV infusion of 8mg/kg (maximum dose of 800 mg). Dose was not adjusted for weight more than 100 kg. After first dose, if fiver persists within 12 hours, a second dose was administrated. A maximum of two doses was allowed.

Primary Outcome Measure

Hematic biometry [ Time Frame: 24 hours ]