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

Primary Purpose

Covid19, Dexamethasone

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Dexamethasone

About this trial

This is an interventional treatment trial for Covid19 focused on measuring dexamethasone, covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients admitted with SARS-CoV-2 (COVID19) pneumonia confirmed by antigenic test or PCR Age ≥ 18 yrs.
pcr ≥ 66 mg/L and ≤150 mg/L at inclusion or Pandemic score at admission > 200 with pcr 9.7-149 mg/L at inclusion.
WHO scale level 4, with need for oxygen therapy in NG ≥ 1 lpm to maintain saturation ≥ 94%.
Onset of symptoms ≤ 10 days before the date of inclusion.
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.

Exclusion Criteria:

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 confirmed past or latent tuberculosis infection prior to inclusion.
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 life expectancy < 3 months at inclusion due to clinical conditions other than SARS-CoV-2 pneumonia.
Patients with expected death in the following 48-72 hours.
Patients included in another clinical trial.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Standard treatment regimen

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

To evaluate whether there is a decrease in the number of NIV/MIV/OCNAF therapy days. To evaluate whether there is a decrease in all-cause mortality at 30, 60 and 90 days. Safety: short- and long-term adverse events related to the following

Full Information

NCT ID

NCT05293210

First Posted

April 26, 2021

Last Updated

February 28, 2023

Sponsor

Hospital Universitario Infanta Leonor

1. Study Identification

Unique Protocol Identification Number

NCT05293210

Brief Title

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

Official Title

Early Treatment Strategy With High-dose Dexamethasone Versus Standard Dose in Patients With SARS-CoV-2 Pneumonia (COVID-19). PREDEXACOV Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 28, 2023 (Anticipated)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitario Infanta Leonor

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

Detailed Description

The use of corticosteroids in COVID 19 in hospitalized patients with moderate symptoms has not been adequately studied in randomized clinical trials, the studies and clinical trials having focused on critical or severe patients. The few studies available to date have yielded evidence of low certainty. Our trial postulates that early intervention and treatment with high-dose corticosteroids (20 mg dexamethasone for 3 days) in patients admitted with pneumonia with respiratory failure and moderate elevation of acute phase reactants and proinflammatory cytokines, or with risk factors that condition worse prognosis on admission, and who have not yet developed data on respiratory distress, the development of the cytokine storm could be avoided or minimized, reducing lung tissue damage and progression to severe respiratory failure and, therefore, reducing the need for invasive and noninvasive respiratory therapies, reducing hospital stay and, possibly, reducing associated mortality. Dexamethasone is a potent synthetic glucocorticoid with actions resembling those of steroid hormones. It acts as an anti-inflammatory and immunosuppressant. It is a widely known glucocorticoid, studied and used in the treatment of autoimmune diseases, in oncology patients under chemotherapy to counteract certain side effects of their antitumor treatment, to augment the antiemetic effects of 5-HT3 receptor antagonists, in patients with brain neoplasms (primary or metastatic) to reduce edema, in spinal cord compressions, in certain hematological malignancies, in the treatment of arthropathies, to counteract allergic shock and septic shock, among many other indications for use. It is also used for the diagnosis of diseases related to hypothalamic-pituitary-adrenal axis dysfunction. Recently, following the DEXA-COVID, CoDEX and RECOVERY clinical trials, dexamethasone has been widely used in patients with severe or critical SARS-CoV-2 pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Dexamethasone

Keywords

dexamethasone, covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Masking Description

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.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard treatment regimen

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

W12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients admitted with SARS-CoV-2 (COVID19) pneumonia confirmed by antigenic test or PCR Age ≥ 18 yrs. pcr ≥ 66 mg/L and ≤150 mg/L at inclusion or Pandemic score at admission > 200 with pcr 9.7-149 mg/L at inclusion. WHO scale level 4, with need for oxygen therapy in NG ≥ 1 lpm to maintain saturation ≥ 94%. Onset of symptoms ≤ 10 days before the date of inclusion. 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. Exclusion Criteria: 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 confirmed past or latent tuberculosis infection prior to inclusion. 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 life expectancy < 3 months at inclusion due to clinical conditions other than SARS-CoV-2 pneumonia. Patients with expected death in the following 48-72 hours. Patients included in another clinical trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Carranza, MD

Phone

+34 911 91 80 00

mariadecarranza@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Angel Pueyo, PHD

Phone

+34 618448807

angel.pueyo@salud.madrid.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Carranza, MD

Organizational Affiliation

Infanta Leonor University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

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

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