Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study ID
NCT04332094
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)
  • Hydroxychloroquine — DRUG
    400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
  • Azithromycin — DRUG
    500 mg / day v.o. for 3 days

Study Details

COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality. Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.

Key Dates

Start date
Apr 2, 2020
Status verified
May 2021
Primary completion
Jun 30, 2021
Completion
Jul 31, 2021

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
  • Active Comparator: Control
    Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.

Primary Outcome Measure

In-hospital mortality [ Time Frame: Through hospitalization, an average of 2 weeks ]

Central Contacts

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