Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease (ASUCOV)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05639192 |
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Recruitment Status :
Recruiting
First Posted : December 6, 2022
Last Update Posted : December 8, 2022
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This clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10).
The investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Biological: Asunercept Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 636 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients With Moderate to Severe COVID 19 Disease |
| Actual Study Start Date : | November 3, 2022 |
| Estimated Primary Completion Date : | November 30, 2023 |
| Estimated Study Completion Date : | November 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Standard of Care + Asunercept 100 mg |
Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion |
| Placebo Comparator: Standard of Care + Placebo |
Other: Placebo
Placebo will be administered once per week as an i.v. infusion |
- Time to sustained recovery [ Time Frame: Day 1-56 ]Sustained improvement (i.e., without decrease) of ≥2 points on the WHO 10 point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first.
- Efficacy in reducing progression to more severe disease or death [ Time Frame: Day 1-28 ]All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol
- ≥18 years of age
- Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test
- Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment
- Patient agrees to not participate in another clinical trial from screening until day 56
Exclusion Criteria:
- Patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.)
- Patient is anticipated to be discharged from hospital within 48 hours
- Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)
- Patient requires invasive mechanical ventilation
- Patient is known to have active tuberculosis
- Patient is known to have hereditary fructose intolerance.
- Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639192
| Contact: Eike C. Buss, MD | +49 6221 586080 | contact@apogenix.com |
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| Study Chair: | Eike C. Buss, MD | Apogenix AG |
| Responsible Party: | Apogenix AG |
| ClinicalTrials.gov Identifier: | NCT05639192 |
| Other Study ID Numbers: |
APG101_CD_018 |
| First Posted: | December 6, 2022 Key Record Dates |
| Last Update Posted: | December 8, 2022 |
| Last Verified: | November 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |