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

NCT04890626 | Completed Phase 3

• 1 other identifier: PanCOVID
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Mortality

  at 28 days

Study Arms (4)

Main randomization.Arm: Emtricitabine / Tenofovir disoproxil fumarate

EXPERIMENTAL

Emtricitabine / Tenofovir disoproxil fumarate

Drug: Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA]

Main randomization.Arm: No treatment

NO INTERVENTION

No treatment

Rescue randomization: Arm: Dexamethasone + Baricitinib

OTHER

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.

Drug: Baricitinib + dexamethasone

Rescue randomization: Arm: Dexamethasone

OTHER

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.

Drug: Dexamethasone

Interventions

Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA] DRUG

Main randomization

Main randomization.Arm: Emtricitabine / Tenofovir disoproxil fumarate

Baricitinib + dexamethasone DRUG

Rescue randomization

Rescue randomization: Arm: Dexamethasone + Baricitinib

Dexamethasone DRUG

Rescue randomization

Rescue randomization: Arm: Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women agree to participate in the study by signing the informed consent.
• Men and women aged ≥ 60 years.
• Men and women aged ≥18 years \<60 years with ≥ 2 comorbidities of the following: hypertension, obesity, diabetes, cirrhosis, chronic neurological disease, active cancer, heart failure, ischemic heart disease, COPD.
• Patient with a diagnosis of SARS-CoV-2 infection confirmed by PCR or rapid diagnostic test prior to randomization.
• Patients with symptoms and signs compatible with active infection.
• Men and women of reproductive capacity must agree to use highly effective contraceptive methods (diaphragm plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or vasectomy) during your participation in the study and within 30 days of the last visit.

You may not qualify if:

• Patients participating in any other clinical trial with drugs with potential antiviral action for SARS-CoV-2
• Concomitant treatment with drugs other than the treatments included in this study with demonstrated or potential action against SARS-CoV-2 in the 24 hours prior to the administration of the study treatment.
• Patients who are already receiving any of the study drugs.
• Patients treated with corticosteroids at immunosuppressive doses (15 mg / day in the 7 days prior to the onset of symptoms).
• Evidence of multi-organ failure.
• ALT or AST\> 5 times the upper limit of normal during screening.
• Creatinine clearance less than 60 ml / min during screening.
• Pregnancy test with positive result during screening.
• Women who are breastfeeding.
• Patients with known hypersensitivity to any of the drugs in the treatment branches of the study, their metabolites or excipients.
• Patients who receive medication incompatible with the study drugs after reviewing possible interactions.
• Patients who present any contraindication or condition that is included in the section on warnings and special precautions for the use of the technical sheets of the drugs under study (Emtricitabine / Tenofovir disoproxil, and remdesivir) or any other reason that the research team has criteria is reason. not to be included in the study.
• Subjects who are not able to understand the information sheet and are unable to sign the informed consent
• Second randomization (if applicable):
• Patients already included in the study and initially randomized may be re-randomized at any time if they present an O2 Sat \<95% (need for oxygen therapy) and at least 1 marker of inflammation of the following: IL-6, CRP, D-Dimer , LDH, or ferritin above the upper limit of the normal range. This randomization can only be done in hospitalized patients. Patients will receive one of the following arms of treatment:

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Interventions

Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; baricitinib; Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Main randomization. Patients will be randomized to Emtricitabine / Tenofovir disoproxil fumarate or no treatment. 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 * dexamethasone

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: April 4, 2020
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)