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Clinical Trials/EUCTR2020-002186-34-ES
EUCTR2020-002186-34-ESActive, not recruitingPhase 1

Efficacy of the early use of corticotherapy in CoV-2 infection to prevent the progression of acute respiratory distress syndrome (ARDS) in COVID-19

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).0 sites100 target enrollmentStarted: July 22, 2020Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Age 18 - 80
  • •2. Coronavirus-19 infection (SARS-CoV-2) demonstrated by nasopharyngeal smears PCR or any other biological sample
  • •3. COVID-19 described as:
  • •- Nasopharyngeal smear with SARS-CoV-2 positive PCR
  • •- Lung infiltrates by radiography (or other imaging technique) consistent with pneumonia
  • •- Puntuation of 3 or 4 in the WHO Ordinal Scale for Clinical Improvement for COVID-19
  • •- One of the following criteria:
  • •a) Ambient air oxygen saturation> 90 and <94%
  • •b) Pa: FiO2 (partial pressure O2 / fraction of inspired O2)> 200 and =300 mmHg
  • •c) Sa: FiO2 (O2 saturation measured with
  • •pulse oximeter / inspired O2 fraction) =350
  • •- All patients will receive standard treatment according to site guidelines (eg hydroxychloroquine), as long as there is no contraindication for it.
  • •5. Informed consent (according to protocol instructions)
  • •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 60
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

  • •1.Previous treatment with oral or intravenous corticosteroids for more than 5 days in a row or alternate days (6 previous months)
  • •2.Treatment during the previous 12 months with biological drugs such as monoclonal antibodies including anti-TNFa, anti-interleukins, Interferons type I.
  • •3.Any other contraindication for the use of individualized corticosteroid pulses according to the clinical criteria of the patient medical team.
  • •4.Contraindications to treatment with methylprednisolone (limited to known hypersensitivity to the active substance and its excipients), as well as receiving treatment in a post-vaccination period (with live or live attenuated microorganism vaccines).
  • •5.Patients with severe SDRA, defined as SaFi < 150.
  • •6.Patients with chronic obstructive pulmonary disease requiring home oxygen.

Investigators

Sponsor
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).

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