Status:
UNKNOWN
Early Treatment Strategy With High-dose Dexamethasone in Patients With SARS-CoV-2
Lead Sponsor:
Hospital Universitario Infanta Leonor
Conditions:
Covid19
Dexamethasone
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05293210
Start Date
February 28 2023
End Date
December 1 2023
Last Update
March 1 2023
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