Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19

Sponsor
Instituto de Investigación Hospital Universitario La Paz
Study ID
NCT04890626
Phase
PHASE3
Status
Completed

Conditions

  • SARS-CoV-2 Infection

Eligibility Criteria

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

Interventions

  • Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA] — DRUG
    Main randomization
  • Baricitinib + dexamethasone — DRUG
    Rescue randomization
  • Dexamethasone — DRUG
    Rescue randomization

Study Details

Currently COVID-19 is an international public health emergency. Most COVID-19 patients have mild or uncomplicated disease, but approximately 14% develop severe disease that requires hospitalization and oxygen therapy, and up to 5% of patients require admission to Intensive Care Units. To date, the only treatments that have shown efficacy in a clinical trial are remdesivir and dexamethasone. The main objective is to provide reliable estimates on the effects of different treatment strategies on the outcome and mortality of patients with SARS-CoV-2 infection.

Key Dates

Start date
Apr 4, 2020
Status verified
Mar 2024
Primary completion
Jul 17, 2023
Completion
Jul 17, 2023

Study Design

Enrollment
356 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Main randomization.Arm: Emtricitabine / Tenofovir disoproxil fumarate
    Emtricitabine / Tenofovir disoproxil fumarate
  • No Intervention: Main randomization.Arm: No treatment
    No treatment
  • Other: Rescue randomization: Arm: Dexamethasone + Baricitinib
    Rescue randomization: patients with oxygen requirements, O2 Sat \<95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone.
  • Other: Rescue randomization: Arm: Dexamethasone
    Rescue randomization: patients with oxygen requirements, O2 Sat \<95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone.

Primary Outcome Measure

Mortality [ Time Frame: at 28 days ]

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