RESCAP® rescue therapy in COVID19 disease

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; COVID 19; MedDRA version: 20.0Level: LLTClassification code 10062357Term: SIRSSystem Organ Class: 100000004867

• Registration Number: EUCTR2020-001714-38-BE
• Lead Sponsor: Jessa Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-02
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

-Sars-CoV-2 infection based on: highly clinical suspicion on admission and/or positive PCR test on naso¬pharynx swab or sputum and/or a CT imaging of the chest compatible with COVID-19 + type 1 or type 2 respiratory failure despite supplemental oxygen that indicates airway support/ICU admittance and meeting any of the following criteria: .
-SpO2 <90% or PaO2/FiO2 < 200 mmHg
-Clinical evidence of respiratory distress (RR > 25 breaths/minute)

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 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

Exclusion Criteria

-Inclusion in another interventional clinical trial
-Age < 18
-Age > 80
-Patients who are pregnant or lactating
-Patients expected to have fatal disease within 24 hours
-Patients who are already on dialysis (Renal Replacement Therapy, RRT) or a decision has been made to initiate RRT within 24 hours after planned start of study drug administration
-Patients who have advanced chronic liver disease confirmed by a Child-Pugh C
-Patients who are having an known history of immune system that has been impaired by disease, such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<0.5 x 109/l) or patients who are receiving chronic high doses (equivalent to prednisone/prednisolone 0.5 mg/kg/day) steroids therapy immediately prior to recruitment exceeding 2 weeks of treatment. This means dexamethasone 6 mg once daily serving as treatment for severe COVID-19 is not an exclusion criteria.
-Patients with active haematological malignancy

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 safety and preliminary efficacy of AP in reducing the inflammatory reaction in COVID-19 patients and thereby shorten time on mechanical ventilation or prevent the need for mechanical ventilation in COVID-19 patients. Secondary Objective(s): To reduce mortality rates and prevent acute kidney injury (AKI) stage 2/3 (KDIGO criteria). ;Timepoint(s) of evaluation of this end point: discharge from the hospital;Secondary Objective: Not applicable;Primary end point(s): (1)Duration of mechanical ventilation and withholding of mechanical ventilation <br>(2)ICU mortality<br>(3)Number (%) of patients with acute kidney injury (AKI) stage 2/3 (KDIGO)<br>(4)Concentration of pro-inflammatory cytokines <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (1)ICU Mortality<br>(2)Number (%) of patients with acute kidney injury (AKI) stage 2/3 (KDIGO criteria)<br>(3)Number (%) of ventilated patients <br>(4)Number (%) of patients in need for reintubation<br>(5)Safety (according to chapter 8)<br>(6)Values of inflammatory markers (e.g. macrophages, neutrophils, lymphocytes and their inflammatory products (TNF-a, IL-6, IL-8, IL-10))<br>;Timepoint(s) of evaluation of this end point: discharge from the hospital