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

Phase 3

Completed

• Conditions: SARS-CoV-2 Infection
• Interventions: Drug: Baricitinib + dexamethasone; Drug: Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA]; Drug: Dexamethasone

• Registration Number: NCT04890626
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-04
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Primary Completion: 2023-07-17
• Study Completion: 2023-07-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rescue randomization: Arm: Dexamethasone + Baricitinib	Baricitinib + 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.
Main randomization.Arm: Emtricitabine / Tenofovir disoproxil fumarate	Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA]	Emtricitabine / Tenofovir disoproxil fumarate
Rescue randomization: Arm: Dexamethasone	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 Measures

Name	Time	Method
Mortality	at 28 days

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain