Covid19Phase 2NCT04834856
Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
A Phase 2 study testing ensovibep in people with Covid19, run by Molecular Partners AG at 1 site in Netherlands.
Trial summary
This study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- ensovibep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2021to 20 Aug 2021
- Phase
- Phase 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women, between 18 and 70 years on the day of inclusion.
- Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.
- Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
Who cannot join
- Requiring hospitalization at time of screening, or at time of study drug administration.
- Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute.
- Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
- Any co-morbidity requiring hospitalization or surgery within <7 days, or that is considered life-threatening within 29 days.
- A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection.
- Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies.
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- Concurrent enrollment in any other type of medical research for improving COVID-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study.
- Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial.
- Severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated HIV and CD4 T-cells <200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study.
- Subjects at high risk for of COVID-19 related complications or mortality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a Open Label, Non-comparative, Single Dose Escalation Study to Evaluate the Dynamics of Viral Clearance, Pharmacokinetics and Tolerability of Ensovibep in Patients With Symptomatic COVID-19 Disease
This study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease
- Conditions
- Covid19
- Being tested
- ensovibep
- Keywords
- SARS-CoV-2, Corona, DARPin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ensovibepDrug
Also called MP0420
The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion.
| Study group | Role | What they receive |
|---|---|---|
| ensovibep dose 1 | Experimental | Not described Receives: Drug: ensovibep |
| ensovibep dose 2 | Experimental | Not described Receives: Drug: ensovibep |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 viral load
Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs
Measured: up to day 29
SARS-CoV-2 viral cultures
Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs
Measured: up to day 29
SARS-CoV-2 PCR days to negativity
Duration in days to SARS-CoV-2 PCR negativity
Measured: up to day 29
Observed maximum concentration (Cmax)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Measured: up to day 91
Terminal Elimination Half-Life (T½)
Measured: up to day 91
Time to Cmax (Tmax)
Measured: up to day 91
The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
Measured: up to day 91
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Measured: up to day 91
Apparent total body clearance of the drug from plasma (CL)
Measured: up to day 91
Apparent volume of distribution at steady state (Vss)
Measured: up to day 91
Secondary outcomes (11)
14 Common Covid-19 Related Symptoms score
Changes in the assessment of 14 Common Covid-19 Related Symptoms score
Measured: up to day 29
Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)
Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study
Measured: up to day 91
Concomitant medication
Intake of concomitant medication will be assessed throughout the study
Measured: up to day 91
Vital Signs: Heart Rate (bpm)
Measured: up to day 91
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Measured: up to day 91
Vital Signs: Respiratory Rate (breaths per minute)
Measured: up to day 91
Vital Signs: Body Temperature (°C)
Measured: up to day 91
Vital Signs: Oxygen Saturation (SpO2)
Measured: up to day 91
Clinical laboratory tests (hematology and blood chemistry)
Measured: up to day 91
Physical examinations (symptom directed)
Measured: up to day 91
Local tolerability at injection site
Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score
Measured: up to 90 min post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Partners AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834856
- Sponsor's protocol ID
- MP0420-CP204
- Other IDs
- 2021-000365-33
- Status last verified
- Sep 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Open Label, Non-comparative, Single Dose Escalation Study to Evaluate the Dynamics of Viral Clearance, Pharmacokinetics and Tolerability of Ensovibep in Patients With Symptomatic COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04834856
- Acronym / sponsor ID
- MP0420-CP204
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Corona, DARPin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Molecular Partners AGIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 8 Apr 2021 (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 study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ensovibep dose 1 | Experimental | Drug: ensovibep |
| ensovibep dose 2 | Experimental | Drug: ensovibep |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or non-pregnant women, between 18 and 70 years on the day of inclusion.
- Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.
- Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
Key exclusion criteria (10 listed)
- Requiring hospitalization at time of screening, or at time of study drug administration.
- Oxygen saturation (SpO2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute.
- Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
- Any co-morbidity requiring hospitalization or surgery within <7 days, or that is considered life-threatening within 29 days.
- A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection.
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 |
|---|---|---|
| ensovibepAlso: MP0420The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion. | Drug | ensovibep dose 1, ensovibep dose 2 |
Primary outcome
SARS-CoV-2 viral load
Time frame: up to day 29
Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs
SARS-CoV-2 viral cultures
Time frame: up to day 29
Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs
SARS-CoV-2 PCR days to negativity
Time frame: up to day 29
Duration in days to SARS-CoV-2 PCR negativity
Observed maximum concentration (Cmax)
Time frame: up to day 91
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Terminal Elimination Half-Life (T½)
Time frame: up to day 91
Time to Cmax (Tmax)
Time frame: up to day 91
The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
Time frame: up to day 91
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: up to day 91
Apparent total body clearance of the drug from plasma (CL)
Time frame: up to day 91
Apparent volume of distribution at steady state (Vss)
Time frame: up to day 91
11 secondary outcomes
14 Common Covid-19 Related Symptoms score
Time frame: up to day 29
Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)
Time frame: up to day 91
Concomitant medication
Time frame: up to day 91
Vital Signs: Heart Rate (bpm)
Time frame: up to day 91
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Time frame: up to day 91
Vital Signs: Respiratory Rate (breaths per minute)
Time frame: up to day 91
Vital Signs: Body Temperature (°C)
Time frame: up to day 91
Vital Signs: Oxygen Saturation (SpO2)
Time frame: up to day 91
Clinical laboratory tests (hematology and blood chemistry)
Time frame: up to day 91
Physical examinations (symptom directed)
Time frame: up to day 91
Local tolerability at injection site
Time frame: up to 90 min post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ensovibep in people with Covid19, run by Molecular Partners AG at 1 site in Netherlands.
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 10 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: finished, as of the sponsor's last update on 8 Sep 2021. 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 Netherlands. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SARS-CoV-2 viral load (time frame: up to day 29). The study lists 10 primary outcomes in all. 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 8 Sep 2021.