A Phase 1 interventional study of Ensovibep and Placebo in COVID-19, sponsored by Molecular Partners AG. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by Molecular Partners AG · Phase 1, Interventional, and Other
Among 340 studies in COVID-19 with a site in United Kingdom — 17 open to participants now, 32 under way, 7 of them phase 3. COVID-19 · United Kingdom.
Among the 340 studies in COVID-19 with a site in United Kingdom, this one is the 133rd largest by enrollment of the 172 interventional ones that give a count, is one of 192 that started in 2020, is one of 21 in phase 1, and was the 232nd registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →17 of the 340 studies in COVID-19 with a site in United Kingdom are open now. Recruiting first, the newest first:
Imperial College London · Sites in United Kingdom
Merck Sharp & Dohme LLC · Sites in United Kingdom, United States, Argentina and 21 more countries
Technical University of Munich · Sites in United Kingdom, Austria, Belgium and 2 more countries
University Hospital Southampton NHS Foundation Trust · Sites in United Kingdom
AstraZeneca · Sites in United Kingdom, United States, Argentina and 36 more countries
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
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 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
340 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 28 · Phase 2 52 · Phase 3 66 · Phase 4 5
First in 2013; this study’s year is marked. 192 started in 2020.
This study's enrollment of 53 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Median enrollment 247 across the 172 interventional studies, 296 across the 167 observational. Of the 245 that completed or were terminated, 75 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
89 of 340 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.
5 of the studies in COVID-19 with a site in United Kingdom that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03188796Phase 3Medical University of GrazThe VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients | 2027-07 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT04746183University of LiverpoolAGILE (Early Phase Platform Trial for COVID-19) | 2027-03-31 |
| NCT04863573Queen's University, BelfastCOVID-19 Antibody Responses In Cystic Fibrosis | 2027-08 |
| NCT06452654Technical University of MunichAnti-viral Action Against Type 1 Diabetes Autoimmunity | 2027-10 |
Among the 340 studies in COVID-19 with a site in United Kingdom, 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 safety and the tolerability of ensovibep in healthy volunteers
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Placebo
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
Drug: Ensovibep
The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.
Also known as: MP0420, DARPin, COVID-19 treatment
One administration at day 1 by infusion.
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Time frame: up to day 100 (EOS)
Vital Signs: Heart Rate (bmp)
Time frame: up to day 100 (EOS)
Vital Signs: Tympanic Temperature (°C)
Time frame: up to day 100 (EOS)
Vital Signs: Oxygen Saturation (SpO2%)
Time frame: up to day 100 (EOS)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
Time frame: up to day 100 (EOS)
Physical Examination
For safety purpose, the following will be examined during full physical examinations: general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities; and the following systems will be assessed: musculoskeletal and neurological.
Time frame: up to day 100 (EOS)
Number of subjects with Laboratory Abnormalities
Time frame: up to day 100 (EOS)
Assessment of local tolerability
Number of subjects with reaction at the injection site. The injection site is assessed for any pain, tenderness, erythema and induration.
Time frame: up to day 100 (EOS)
Number of subjects with Adverse Events
Time frame: up to day 100 (EOS)
Observed maximum concentration (Cmax)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Time frame: up to day 100 (EOS)
Time to Cmax (Tmax)
Time frame: up to day 100 (EOS)
The area under the serum concentration-time curve (AUC)
Time frame: up to day 100 (EOS)
Apparent total body clearance of the drug from plasma (CL)
Time frame: up to day 100 (EOS)
The apparent volume of distribution during terminal phase after drug administration (Vz)
Time frame: up to day 100 (EOS)
Terminal Elimination Half-Life (T½)
Time frame: up to day 100 (EOS)
Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
Time frame: up to day 100 (EOS)
Ran from Nov 2020 to primary completion in Jan 2022, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ensovibep
Molecular Partners AG