Random, controlled, open, one-site clinical trial in adult patients with COVID-19 severe pneumonia treated with immunomodulatory drugs

Phase 1

• Conditions: Severe COVID-19 pneumonia; MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001437-12-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-13
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. Age 18-80 years
2. Severe COVID-19 pneumonia definied as:
-Nasnopharyngeal smear SARS-CoV-2 PCR positive
-Pulmonary infiltrates by simple X-ray (or other technique) compatible with pneumonia
-One or more of the following criteria:
oRoom air oxygen saturation <= 94% measured by pulse oximeter
oPa:FiO2 (partial pressure O2/fraction of inspired O2) <=300
oSa:FiO2 (O2 saturation measured by pulse oximeter/ fraction of inspired O2) <=350
3. 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 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

1. GOT/GPT > 5 the institutional ULN
2. Neutrophils < 500 cell/mmc.
3. Petelet < 50.000 cell/mmc.
4. Documented sepsis o pneumonia different from COVID-19.
5. According to clinician criteria, comorbilities with poor prognosis
6. Compliate Diverticulitis or bowel perforation
7. Current skin infection (p.e piodermitis)
8. According to the clinician criteria, any contraindication for using inmunomodulator tretament.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the mortality impact at 28 days of an immunomodulatory strategy with 2 treatment regimens stratified according to IL-6 plasma levels, administered in addition to standard treatment, in adult patients with severe COVID-19 pneumonia.;Secondary Objective: To assess the impact of this strategy on the following variables: premature mortality (48 hours, 7 days and at hospital), mortality at intensive care unit, days of mechanical ventilation, virus clearance (viral clearance / viral shedding), time to normalization of oxygen saturation , time to defervescence, improvement of inflammatory reaction, days of hospitalization, days of intubation, safety and tolerability of the intervention;Primary end point(s): Mortality at day 28 after treatment initiation (proportion of patient died that day);Timepoint(s) of evaluation of this end point: Day 28 after treatment initiation