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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05293210
• Other study ID #: PREDEXACOV
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 28, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2022
• Source: Hospital Universitario Infanta Leonor
• Contact: Maria Carranza, MD
• Phone: +34 911 91 80 00
• Email: mariadecarranza[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Dexamethasone

Intervention

Drug:
• Dexamethasone
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Infanta Leonor

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	W12