High-dose dexamethasone treatment for SARS-COV-2

Phase 1

• Conditions: Adult patients with SARS-CoV-2 infection (COVID19) requiring hospital admission for pneumonia. Who present pcr = 66 mg/L and =150 mg/L at inclusion or Pandemic score [13] on admission > 200 with pcr 9.7-149 mg/L at inclusion. WHO scale level 4 [14], with need for oxygen therapy in NG = 1 lpm to maintain saturation = 94%.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-001416-29-ES
• Lead Sponsor: Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Unive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-26
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients admitted with SARS-CoV-2 pneumonia (COVID19) confirmed by antigenic test or PCR Age = 18 years.
presents with a pcr = 66 mg/L and =150 mg/L at inclusion or Pandemic score [13] at admission > 200 with pcr 9.7-149 mg/L at inclusion
WHO scale level 4 [14], with need for oxygen therapy in NG = 1 lpm to maintain saturation = 94%.
Onset of symptoms = 10 days before the date of inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Patients with criteria of respiratory distress at the time of randomisation, understood as need for OCNAF/NIMV/MIV (levels 5 and 6 of the WHO scale) or O2 saturation = 92% and/or RF = 30 despite oxygen in NG at 4 litres.

Patients with allergy or contraindication to the use of systemic corticosteroids.

Patients with severe asthma or chronic lung disease with home oxygen requirements and active corticosteroid therapy.

Patients on chronic corticosteroid therapy

Use of corticosteroids daily in the 15 days prior to hospital admission.

Indication for steroid 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 time of randomisation

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 oncological processes in the last year or on active treatment with chemotherapy.

Patients with life expectancy < 3 months at inclusion due to clinical conditions other than SARS-CoV-2 pneumonia.

Patients expected to die within 48-72 hours.

Patients included in another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified