COVID-19Phase 3ASUCOVNCT05639192
Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease
A Phase 3 study testing Asunercept in people with COVID-19, run by Apogenix GmbH at 39 sites in 9 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Asunercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 39 sitesin 9 countries
- Study dates
- 3 Nov 2022to 18 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
India11 sites
Citizen Hospital
Bangalore, Karnataka
Victoria Hospital, BMCRI Bangalore Medical College & Research Institute
Bangalore
Govtl. Medical College and Hospital Aurangabad
Chhatrapati Sambhajinagar, Maharashtra
Atharva Multispecialty Hospital and Research Center
Lucknow, Uttar Pradesh
JSS Hospital
Mysore, Karnataka
KLES Dr. Prabhakar Kore Hospital & Medical Research Center
Nehru Nagar
Spandan Hospital
Pune, Maharashta
PCMC PGI Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra
Unity Hospital
Sūrat
Ashirwad Hospital and Research Centre
Ulhasnagar, Maharashtra
King George Hospital
Visakhapatnam, Andrha Pradesh
South Africa5 sites
Lakeview Hospital
Benoni
Synapta Clinical Research, 704 Durban Medical Centre
Durban
Helen Joseph Hospital
Johannesburg
Global Clinical Trials
Pretoria, Gauteng
FCRN Clinical Trials Centre
Three Rivers
Spain5 sites
Hospital General Universitario de Alicante Dr. Balmis
Alicante
Hospital del Mar
Barcelona
Complejo Asistencial Universitario de Salamanca
Salamanca
Hospital Universitario Río Hortega
Valladolid
Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro
Vigo
France4 sites
CHU Amiens - Site Sud, Centre de Recherche Clinique
Amiens
Dubois Hospital, Service de médecine intensive Réanimation
Brive-la-Gaillarde
CHU de Limoges - Hopital Dupuytren
Limoges
Georges Pompidou European Hospital
Paris
Georgia4 sites
Ltd "Hospital Service"
Kutaisi
Ltd "Academician Nikoloz Kipshidze Central University Clinic"
Tbilisi
Ltd "Academician Vakhtang Bochorishvili Clinic"
Tbilisi
Ltd "TSMU and Ingorokva High Medical Technology University Clinic"
Tbilisi
Italy4 sites
ASST Santi Paolo e Carlo
Milan
ASST Fatebenefratelli Sacco
Milan
Azienda Ospedaliera Universitaria L. Vanvitelli
Naples
Azienda Ospedaliere Universitaria Federico I
Naples
Poland3 sites
ZOZ w Boleslawcu
Bolesławiec
Nicolaus Copernicus Hospital
Koszalin
Regional Specialist Hospital
Wroclaw
Germany2 sites
Uniklinik Köln - Klinik I für Innere Medizin
Cologne
Universitätsklinikum Heidelberg
Heidelberg
About this study
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
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).
- Conditions
- COVID-19
- Being tested
- Asunercept, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsunerceptBiological
Asunercept (APG101) will be administered once per week as an i.v. infusion
PlaceboOther
Placebo will be administered once per week as an i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + Asunercept 100 mg | Experimental | Not described Receives: Biological: Asunercept |
| Standard of Care + Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sustained recovery
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.
Measured: Day 1-56
Secondary outcomes (1)
Efficacy in reducing progression to more severe disease or death
All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28
Measured: Day 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start3 Nov 2022
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apogenix GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eike C. Buss, MD, Study chair, Apogenix AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639192
- Sponsor's protocol ID
- APG101_CD_018
- Acronym
- ASUCOV
- Status last verified
- Nov 2022
- First submitted
- 3 Dec 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05639192
- Acronym / sponsor ID
- ASUCOV / APG101_CD_018
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Apogenix GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + Asunercept 100 mg | Experimental | Biological: Asunercept |
| Standard of Care + Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsunerceptAsunercept (APG101) will be administered once per week as an i.v. infusion | Biological | Standard of Care + Asunercept 100 mg |
| PlaceboPlacebo will be administered once per week as an i.v. infusion | Other | Standard of Care + Placebo |
Primary outcome
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.
1 secondary outcome
Efficacy in reducing progression to more severe disease or death
Time frame: Day 1-28
Results and safety
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eike C. Buss, MD study chair
Apogenix AG
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Asunercept in people with COVID-19, run by Apogenix GmbH at 39 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in India, South Africa, Spain, France, Georgia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained recovery (time frame: Day 1-56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.