Early Treatment Strategy With High-dose Dexamethasone in Patients With SARS-CoV-2

NCT05293210 | Unknown Phase 3

• 1 other identifier: PREDEXACOV
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Early identification and treatment of this inflammatory cascade using existing therapeutic strategies with proven safety profiles could change the course and prognosis of COVID-19 infection, reducing mortality rates. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death

Conditions

Covid19; Dexamethasone

Keywords

dexamethasone; covid19

Outcome Measures

Primary Outcomes (1)

• Evaluate if there is a decrease in the proportion of patients who develop respiratory distress

  * To evaluate whether there is a decrease in the proportion of patients who develop respiratory distress with the need for NIV/MIV/OCNAF (measured group and individually by respiratory therapies). * To evaluate the impact of this strategy on the number of days of hospitalization.

  Week 12

Secondary Outcomes (1)

• Evaluate if there is a decrease in the number of therapy days

  W12

Study Arms (2)

Experimental arm

EXPERIMENTAL

A daily dose of dexamethasone 20 mg intravenous for 3 days, followed by a daily dose of dexamethasone 6 mg intravenous or oral for 7 days.

Drug: Dexamethasone

Standard treatment regimen

ACTIVE COMPARATOR

Dexamethasone 6 mg orally or intravenously for 10 days (with the possibility of escalation to doses of 20 mg daily of oral or intravenous dexamethasone for 3 days if clinical criteria of respiratory distress develop despite treatment with doses of dexamethasone 6 mg daily).

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

A daily dose of dexamethasone 20 mg intravenous for 3 days, followed by a daily dose of dexamethasone 6 mg intravenous or oral for 7 days. Dexamethasone 6 mg orally or intravenously for 10 days (with the possibility of escalation to doses of 20 mg daily of oral or intravenous dexamethasone for 3 days if clinical criteria of respiratory distress develop despite treatment with doses of dexamethasone 6 mg daily).

Experimental arm; Standard treatment regimen

Eligibility Criteria

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

You may qualify if:

• Patients admitted with SARS-CoV-2 (COVID19) pneumonia confirmed by antigenic test or PCR Age ≥ 18 yrs.
• WHO scale level 4, with need for oxygen therapy in NG ≥ 1 lpm to maintain saturation ≥ 94%.
• After having received verbal and written information about the study, the patient must submit the signed and dated Informed Consent before performing any activity related to the study.

You may not qualify if:

• Patients with respiratory distress criteria at the time of randomization, understood as need for OCNAF/VMNI/VMI (levels 5 and 6 of the WHO scale) or O2 saturation ≤ 92% and/or FR ≥ 30 despite oxygen in NG at 4 liters.
• Patients with allergy or contraindication to the use of systemic corticosteroids.
• Patients with severe asthma or chronic pulmonary pathology with home oxygen requirements and active treatment with corticosteroids.
• Patients on chronic corticosteroid treatment.
• Use of corticosteroids daily in the 15 days prior to hospital admission.
• Indication of corticosteroid use due to other clinical conditions of the patient (e.g., septic shock).
• Pregnant or actively breastfeeding women
• Patients with suspected or confirmed bacterial, fungal, or viral infection other than SARS-CoV-2 itself at the time of randomization
• Patients with known HIV infection with CD4 below 500 cells/mm3 or on active treatment with protease inhibitors or boosters such as cobicistat or ritonavir.
• Patients with active oncologic processes in the last year or in active treatment with chemotherapy.
• Patients with expected death in the following 48-72 hours.
• Patients included in another clinical trial.

Sponsors & Collaborators

• Hospital Universitario Infanta Leonor: lead

MeSH Terms

Conditions

COVID-19

Interventions

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Maria Carranza, MD

  Infanta Leonor University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Carranza, MD

CONTACT

+34 911 91 80 00; mariadecarranza@gmail.com

Angel Pueyo, PHD

CONTACT

+34 618448807; angel.pueyo@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients who meet all inclusion criteria and none of the exclusion criteria will be randomized to receive a daily dose of dexamethasone 20 mg intravenous for 3 days, followed by a daily dose of oral or intravenous dexamethasone 6 mg for 7 more days versus the center's standard treatment which includes the use of oral or intravenous dexamethasone 6 mg for 10 days with escalation to a daily dose of oral or intravenous dexamethasone 20 mg for 3 days if clinical criteria of respiratory distress develop despite treatment with dexamethasone 6 mg daily. Randomization will be performed in a centralized manner. Randomization will be done directly in the database itself by including the patient in the CRD-e (Redcap). When the investigator registers a patient in the CRD-e, the system will directly assign him/her to which group he/she has been randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study consists of 2 phases: * Hospitalization phase: Day 1 of IC signature to day of hospital discharge. In case of not having completed 10 days of hospitalization since inclusion, patients will have to complete the 10 days of treatment on an outpatient basis. This medication will be provided by the Hospital Pharmacy. In case of discharge, the information will be obtained from the patients in person or by telephone contact, according to their needs, with the patient himself or his caregivers and/or cohabitants. * Follow-up phase: outpatient visits at 30, 60 and 90 days. The information is obtained from the patients, from the medical records or by telephone contact with the patient himself or his caregivers and/or cohabitants according to availability and need of the patient.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: March 24, 2022
• Study Start: February 28, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 1, 2023

Record last verified: 2022-04