Early identification and treatment of this inflammatory cascade using existingtherapeutic strategies with proven safety profiles could change the course and prognosisof COVID-19 infection, reducing mortality rates. Glucocorticoids may modulateinflammation-mediated lung injury and thereby reduce progression to respiratory failureand death
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.
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).
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.
Not Provided
Maria Carranza, MD
+34 911 91 80 00
mariadecarranza@gmail.com
Angel Pueyo, PHD
+34 618448807
angel.pueyo@salud.madrid.org
Maria Carranza, MD, Principal Investigator
Infanta Leonor University Hospital