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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Infanta Leonor
• Treatments: Dexamethasone

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.