Asunercept for the treatment of patients with moderate to severe COVID-19 disease

Phase 1

• Conditions: Moderate to Severe COVID-19 Disease; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-006005-30-PL
• Lead Sponsor: Apogenix AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-27
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

1. The patient or his/her legal authorized representative (in case the patient is unable to give consent due to his/her medical condition) has given informed consent to participate in the trial and to adhere to the procedures stated in the protocol
2. The patient is a male or female adult aged =18 years at the time of giving informed consent
3. The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test
4. The patient has clinical symptoms indicative of moderate or severe illness (corresponding to score 5 [oxygen by mask or nasal prongs] or 6 [oxygen by non-invasive ventilation or high flow] on the WHO 10-point clinical progression scale) with COVID-19 prior to trial treatment on d1: Radiologically confirmed pneumonia due to COVID-19 and/ or clinical signs suggestive of moderate/severe illness with COVID-19
5. The patient is willing to follow effective measures of contraception during the trial
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 512
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128

Exclusion Criteria

1. The patient is moribund or has an estimated life expectancy <1 month
2. The patient is pregnant or breastfeeding
3. The patient is anticipated to be discharged from hospital within 48 hrs
4. The patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19. In addition, SoC comprises medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)
5. The patient requires invasive mechanical ventilation
6. The patient is known to have active tuberculosis
7. The patient is known to have hereditary fructose intolerance
8. The patient is known to have co-infection with Influenza viruses or other viral respiratory infections
9. The patient was or is currently participating in any investigational clinical study, other than observational, within 30 days prior to enrollment.

Study & Design

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