Covid19Phase 1/2NCT04674566
Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19
A Phase 1/2 study testing COR-101 in people with Covid19, run by Corat Therapeutics Gmbh at 1 site in Germany.
Trial summary
Primary objectives Part 1: To evaluate the safety and tolerability of COR-101 compared to placebo Secondary objectives Part 1: To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19 To assess the pharmacokinetics (PK), pharmacodynamics (PD), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- COR-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 21 Apr 2021to 30 Oct 2022
- Phase
- Phase 1/2
- 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
- Hospitalized for COVID-19 illness for ≤72 hours
- Positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test
- Presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID19 prior to study treatment
Who cannot join
- Diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19
- In the opinion of the investigator, is not likely to survive for >48 hours beyond Day 1
- New onset stroke or seizure disorder during hospitalization and prior to Day 1
- History of relevant CNS pathology or current relevant CNS pathology
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen
Helmut Salih
About this study
Official title: Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, First-in-human, Phase Ib/II Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of COR-101 in Hospitalized Patients
Primary objectives Part 1:
- To evaluate the safety and tolerability of COR-101 compared to placebo
Secondary objectives Part 1:
- To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19
- To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101
- Conditions
- Covid19
- Being tested
- COR-101, 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.
COR-101Drug
Administered intravenously (IV) single dose
PlaceboDrug
Administered intravenously (IV) single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | COR-101 low dose Receives: Drug: COR-101; Drug: Placebo |
| Cohort 2 | Experimental | COR-101 mid dose 1 Receives: Drug: COR-101; Drug: Placebo |
| Cohort 3 | Experimental | COR-101 mid dose 2 Receives: Drug: COR-101; Drug: Placebo |
| Cohort 4 | Experimental | COR-101 high dose Receives: Drug: COR-101; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)
Measured: through Day 28
Proportion of patients with Serious Adverse Events (SAEs)
Measured: through Day 28
Proportion of patients with Adverse Events of Special Interest (AESI)
Measured: through Day 28
Secondary outcomes (9)
Secondary efficacy endpoint: Proportion of patients with disease progression
Proportion of patients who are not alive or have respiratory failure
Measured: through Day 28
Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2
Measured: through Day 28
Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101
Measured: through Day 60
Assessment of PK parameter: Time to Cmax (tmax) for COR-101
Measured: through Day 60
Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101
Measured: through Day 60
Assessment of PK parameter: Clearance (CL) for COR-101
Measured: through Day 60
Assessment of PK parameter: Mean residence time (MRT) of COR-101
Measured: through Day 60
Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR
Measured: through Day 21
Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101
Measured: through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start21 Apr 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corat Therapeutics Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Salih, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674566
- Sponsor's protocol ID
- COR-101/001
- Status last verified
- May 2022
- First submitted
- 17 Dec 2020
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marconato M, Hackenbruch C, Jager S, Gopel S, capital KA, Cyrillicirieieva T, Gavrylov A, Fricke H, Hust M, Dubel S, Dings C, Lehr T, Cuevas M, Bitzer M, Klein C, Schwab M, Wirtz H, Schneider J, Bitter T, Frenzel A, Dhaen MA, Herrmann A, Jung G, Walz JS, Salih HR, Heitmann JS. Phase I Study Evaluating a Monoclonal Fc-Silenced SARS-CoV-2 Antibody in Patients With Moderate-to-Severe COVID-19. Clin Ther. 2026 Mar;48(3):232-239. doi: 10.1016/j.clinthera.2026.01.004. Epub 2026 Feb 7.
PubMed 41654452Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, First-in-human, Phase Ib/II Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of COR-101 in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04674566
- Acronym / sponsor ID
- COR-101/001
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Corat Therapeutics GmbhIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 19 Dec 2020 (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.
Primary objectives Part 1:
- To evaluate the safety and tolerability of COR-101 compared to placebo
Secondary objectives Part 1:
- To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19
- To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: COR-101, Drug: PlaceboCOR-101 low dose |
| Cohort 2 | Experimental | Drug: COR-101, Drug: PlaceboCOR-101 mid dose 1 |
| Cohort 3 | Experimental | Drug: COR-101, Drug: PlaceboCOR-101 mid dose 2 |
| Cohort 4 | Experimental | Drug: COR-101, Drug: PlaceboCOR-101 high dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized for COVID-19 illness for ≤72 hours
- Positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test
- Presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID19 prior to study treatment
Key exclusion criteria (4 listed)
- Diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19
- In the opinion of the investigator, is not likely to survive for >48 hours beyond Day 1
- New onset stroke or seizure disorder during hospitalization and prior to Day 1
- History of relevant CNS pathology or current relevant CNS pathology
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 |
|---|---|---|
| COR-101Administered intravenously (IV) single dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboAdministered intravenously (IV) single dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)
Time frame: through Day 28
Proportion of patients with Serious Adverse Events (SAEs)
Time frame: through Day 28
Proportion of patients with Adverse Events of Special Interest (AESI)
Time frame: through Day 28
9 secondary outcomes
Secondary efficacy endpoint: Proportion of patients with disease progression
Time frame: through Day 28
Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2
Time frame: through Day 28
Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101
Time frame: through Day 60
Assessment of PK parameter: Time to Cmax (tmax) for COR-101
Time frame: through Day 60
Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101
Time frame: through Day 60
Assessment of PK parameter: Clearance (CL) for COR-101
Time frame: through Day 60
Assessment of PK parameter: Mean residence time (MRT) of COR-101
Time frame: through Day 60
Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR
Time frame: through Day 21
Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101
Time frame: through Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 41654452Marconato M, Hackenbruch C, Jager S, Gopel S, capital KA, Cyrillicirieieva T, Gavrylov A, Fricke H, Hust M, Dubel S, Dings C, Lehr T, Cuevas M, Bitzer M, Klein C, Schwab M, Wirtz H, Schneider J, Bitter T, Frenzel A, Dhaen MA, Herrmann A, Jung G, Walz JS, Salih HR, Heitmann JS. Phase I Study Evaluating a Monoclonal Fc-Silenced SARS-CoV-2 Antibody in Patients With Moderate-to-Severe COVID-19. Clin Ther. 2026 Mar;48(3):232-239. doi: 10.1016/j.clinthera.2026.01.004. Epub 2026 Feb 7.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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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.
Helmut Salih principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing COR-101 in people with Covid19, run by Corat Therapeutics Gmbh at 1 site in Germany.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Ann Dhaen (+4981313563724, m.dhaen@corat-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Treatment-Emergent Adverse Events (TEAEs) (time frame: through Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674566, which also lists 2 linked publications.
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 25 May 2022.