Ambulatory Symptomatic COVID-19 infected patients
Conditions
Interventions
Sodium chloride
Sponsors
Molecular Partners AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women = 18 years of age on the day of inclusion (no upper limit). 2. Presence of two or more COVID-19 symptoms and onset within 7 days prior to dosing: Feeling hot or feverish, cough, sore throat, low energy or tiredness, headache, muscle or body aches, chills or shivering, and shortness of breath. 3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test). 4. Understand and agree to comply with the planned study procedures. 5. The patient or legally authorized representative give signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Requiring hospitalization at time of screening, or at time of study drug administration. 2. Oxygen saturation (SpO2) = 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300, respiratory rate = 30 per minute, and heart rate = 125 per minute. 3. Known allergies to any of the components used in the formulation of the ensovibep or placebo. 4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention. 5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. 6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing. 7. Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and nonsteroidal anti-inflammatories [NSAIDs]) are permitted. Prior vaccination for COVID-19 is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A-Outcome measure title: SARS-CoV-2 viral load. Description: Time-weighted change from baseline (measured at Day 3, Day 5, and Day 8) in SARS-CoV-2 viral load in nasopharyngeal swabs through Day 8 ;Part B-Outcome measure title: Occurrence of hospitalizations, emergency room visits or death. Description: Proportion of patients experiencing hospitalizations (= 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A-Outcome measure title: Occurrence of hospitalizations, emergency room visits or death Description: Proportion of patients experiencing hospitalizations (= 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29 ;Part A -Outcome measure title: Time to sustained clinical recovery Description: Time to sustained clinical recovery, defined as (a) all symptoms from the modified FDA COVID-19 symptom list scored as moderate or severe at baseline are subsequently scored as mild or absent, AND (b) all symptoms from the modified FDA COVID-19 symptom list scored as mild or absent at baseline are subsequently scored as absent, with no subsequent worsening up to Day 29 ;Part A-Outcome measure title: Serious adverse events (SAEs), AEs of Special Interest (AESIs), vital signs and clinical laboratory measurements Description: In order to evaluate the safety and tolerability of ensovibep, the proportion of patients up to end of study with: (a) SAEs, including death from any cause and (b) AESIs, including infusion-related reactions (IRRs) CTCAE grade 2 or higher, will be assessed. Vital signs and clinical laboratory measurements will be assessed too. ;Part A Outcome measure title: Ensovibep concentration in serum and calculated pharmacokinetics (PK) parameters Description: In order to characterize the PK of ensovibep, free and total ensovibep concentration in serum and calculated PK parameters will be determined. ;Part B- Outcome measure title: SARS-CoV-2 viral load Time frame: 8 days (days 1, 3, 5 and 8) Description: Time-weighted change from baseline (measured at Day 3, Day 5, and Day 8) in SARS-CoV-2 viral load in nasopharyngeal swabs through Day 8 ;Part B- Outcome measure title: Time to sustained clinical recovery Description: Time to sustained clinical recovery, defined as (a) all symptoms from the modified FDA COVID-19 symptom list scored as moderate or severe at baseline are subsequently scored as mild or | — |
Countries
Kenya
Contacts
Public ContactMedical Director MPAG Medical Director MPAG
Medical Director MPAG
Outcome results
None listed