A Phase 2 interventional study of ensovibep in Covid19, sponsored by Molecular Partners AG. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Molecular Partners AG · Phase 2, Interventional, and Treatment
Among 104 studies in COVID-19 with a site in Netherlands — 7 open to participants now, 11 under way, 3 of them phase 3. COVID-19 · Netherlands.
Among the 104 studies in COVID-19 with a site in Netherlands, this one is the 49th largest by enrollment of the 50 interventional ones that give a count, is one of 28 that started in 2021, is one of 8 in phase 2, and was the 60th registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →7 of the 104 studies in COVID-19 with a site in Netherlands are open now. Recruiting first, the newest first:
Pfizer · Sites in Netherlands, United States, Argentina and 15 more countries
Franciscus Gasthuis · Sites in Netherlands
Unity Health Toronto · Sites in Netherlands, United States, Argentina and 5 more countries
University of Oxford · Sites in Netherlands, Belgium, Estonia and 13 more countries
UMC Utrecht · Sites in Netherlands, United States, Australia and 26 more countries
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
104 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 16 · Phase 3 18 · Phase 4 7
First in 2014; this study’s year is marked. 28 started in 2021.
This study's enrollment of 12 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Median enrollment 221 across the 50 interventional studies, 723 across the 53 observational. Of the 75 that completed or were terminated, 12 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 104 have an industry lead sponsor. The 10 most frequent:
Molecular Partners AG is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Molecular Partners AG has 2 studies filed under COVID-19 — fewer than ten, so there is no comparison to draw.
2 of the studies in COVID-19 with a site in Netherlands that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT03963622Unity Health TorontoCareful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19) | 2027-06 |
Among the 104 studies in COVID-19 with a site in Netherlands, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ensovibep
Drug: ensovibep
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.
Also known as: MP0420
SARS-CoV-2 viral load
Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs
Time frame: 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
Time frame: up to day 29
SARS-CoV-2 PCR days to negativity
Duration in days to SARS-CoV-2 PCR negativity
Time frame: up to day 29
Observed maximum concentration (Cmax)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Time frame: up to day 91
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
14 Common Covid-19 Related Symptoms score
Changes in the assessment of 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)
Treatment-emergent (S)AEs and AESIs, including infusion-related reactions (IRRs) will be assessed throughout the study
Time frame: up to day 91
Concomitant medication
Intake of concomitant medication will be assessed throughout the study
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
Local tolerability at injection site will be assessed via Visual Infusion Phlebitis score
Time frame: up to 90 min post dose
Ran from Apr 2021 to primary completion in Aug 2021, 4 months.
Of 223 industry-sponsored phase 2 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 13. This study's 4 months is below that.
Counting every sponsor, half of 582 studies reached it within 9 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ensovibep
Molecular Partners AG