Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107832151388 Date of Approval: 02/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19 – The “EMPATHY” Trial
Official scientific title A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19 – The “EMPATHY” Trial
Brief summary describing the background and objectives of the trial The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients Primary objectives: Part A The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8. Part B The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of 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 objectives: Part A The secondary objectives of this Part are: • To assess the effect of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29 • To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms through Day 29 • To evaluate safety and tolerability of ensovibep • To characterize the pharmacokinetics (PK) of ensovibep Part B The secondary objectives of this Part are: • To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8 • To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms up to Day 29 • To evaluate the immunogenicity of ensovibep and its clinical relevance (pharmacokinetic, efficacy, and safety). • To evaluate safety and tolerability of ensovibep
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EMPATHY
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ambulatory Symptomatic COVID-19 infected patients
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/04/2021
Actual trial start date
Anticipated date of last follow up 31/05/2022
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 2100
Actual target sample size (number of participants) 0
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ensovibep 75 mg administered as a single intravenous (i.v.) infusion administered as a single intravenous (i.v.) infusion over 60 minutes Ensovibep IMP is supplied as a sterile isotonic solution for IV administration. While the pure MP0420 IMP is colorless to slightly colored and clear to slightly opalescent, no visual differences can be noted between the compounded infusion bag and the placebo bag. 100
Experimental Group Ensovibep 225 mg administered as a single intravenous (i.v.) administered as a single intravenous (i.v.) infusion over 60 minutes Ensovibep IMP is supplied as a sterile isotonic solution for IV administration. While the pure MP0420 IMP is colorless to slightly colored and clear to slightly opalescent, no visual differences can be noted between the compounded infusion bag and the placebo bag. 100
Experimental Group Ensovibep 600 mg administered as a single intravenous (i.v.) infusion administered as a single intravenous (i.v.) infusion over 60 minutes Ensovibep IMP is supplied as a sterile isotonic solution for IV administration. While the pure MP0420 IMP is colorless to slightly colored and clear to slightly opalescent, no visual differences can be noted between the compounded infusion bag and the placebo bag. 100
Control Group Sodium chloride A 250 mL 0.9% NaCl bag (without addition of MP0420 IMP) administered as a single intravenous (i.v.) infusion over 60 minutes While the pure MP0420 IMP is colorless to slightly colored and clear to slightly opalescent (refer to section 3), no visual differences can be noted between the compounded infusion bag and the placebo bag. 950 Placebo
Experimental Group Ensovibep administered as a single intravenous (i.v.) infusion over 60 minutes Ensovibep IMP is supplied as a sterile isotonic solution for IV administration. While the pure MP0420 IMP is colorless to slightly colored and clear to slightly opalescent, no visual differences can be noted between the compounded infusion bag and the placebo bag. 850
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/07/2021 Amref Ethics and Scientific Review Committee ESRC
Ethics Committee Address
Street address City Postal code Country
Langata Road opposite Wilson Airport Nairobi 27663 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 11/06/2021 The Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road HOUSE NUMBER 8 KEMRI HEADQUARTERS Nairobi 54840-002 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Time frame: 8 days days 0 3 5 and 8
Primary Outcome 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. Time frame: up to day 29
Secondary Outcome 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 up to day 29
Secondary Outcome 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 up to day 29
Secondary Outcome 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. up to day 91 EOS
Secondary Outcome 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. up to day 91 EOS
Secondary Outcome 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 8 days days 1, 3, 5 and 8
Secondary Outcome 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 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. up to day 29
Secondary Outcome Part B-Outcome measure title: Proportion of patients with treatment-emergent ADAs (TE-ADA) Description: To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (pharmacokinetic, efficacy and safety), proportion of patients exhibiting TE-ADA over time will be determined. up to day 91 EOS
Secondary Outcome Part B-Outcome measure title: SAEs, 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 IRRs CTCAE grade 2 or higher, will be assessed. Vital signs and clinical laboratory measurements will be assessed too. up to day 91 EOS
Secondary Outcome Part A Outcome measure title: Ensovibep concentration in serum and calculated pharmacokinetics (PK) parameter Description: In order to characterize the PK of ensovibep, free and total ensovibep concentration in serum and calculated PK parameters will be determined up to day 91 EOS
Secondary Outcome Part B-Outcome measure title: Proportion of patients with treatment-emergent ADAs (TE-ADA) Description: To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (pharmacokinetic, efficacy and safety), proportion of patients exhibiting TE-ADA over time will be determined. up to day 91 EOS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta University Teaching Referral and Research Hospital KUTRRH Northern Bypass Rd., Kahawa West, Nairobi Nairobi 7674-0010 Kenya
Kenya Medical Research Institute US Army Medical Research Directorate Kericho Hospital Road Kericho 1357 Kenya
Kenya Medical Research Institute US Army Medical Research Directorate Kisumu Field Station Opposite the Kombewa Hospital Kisumu 54-40100 Kenya
KEMRI Centre for Respiratory Disease Research CRDR Kenyatta National Hospital KENYATTA NATIONAL HOSPITAL OFF HOSPITAL ROAD Nairobi 47855 Kenya
Victoria Biomedical Research Institute VIBRI Kisumu County Referral Hospital Angawa Road Kisumu Kisumu 7180 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Novartis Pharma AG Forum 1 , Novartis Campus Basel 4056 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Molecular Partners AG Wagistrasse 14 Schlieren 8952 Switzerland Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Novartis Pharma AG Forum 1, Novartis Campus Basel 4056 Switzerland
Quintiles East Africa Limited IQVIA LANDMARK PLAZA, 13TH FLOOR, ARGWINGS KHODEK ROAD Nairobi 856 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucas Tina ltina@vibriafrica.org +254720597654 Kisumu
City Postal code Country Position/Affiliation
Kisumu 7180 Kenya Victoria Biomedical Research Institute
Role Name Email Phone Street address
Principal Investigator Bernhards Ogutu Ogutu6@gmail.com +254733812613 Madaraka Estate, Ole Sangale rd
City Postal code Country Position/Affiliation
Nairobi 59857 Kenya Centre for Research in Therapeutic Sciences
Role Name Email Phone Street address
Principal Investigator Deborah Langat Deborah.langat@usamru-k.org +254714059596 Kenya Medical Research Institute/Walter Reed Project Hospital Road
City Postal code Country Position/Affiliation
Kericho 1357 Kenya Kenya Medical Research Institute Walter Reed Project
Role Name Email Phone Street address
Principal Investigator Janet Oyieko Janet.Oyieko@usamru-k.org +254721996988 KEMRI-USAMRD-A, Kisumu Field Station,opposite the Kombewa Hospital
City Postal code Country Position/Affiliation
Kisumu 54-40100 Kenya KEMRI USAMRD Kisumu Field Station
Role Name Email Phone Street address
Principal Investigator Videlis Nduba vnduba@gmail.com +254724522474 KENYATTA NATIONAL HOSPITAL OFF HOSPITAL ROAD
City Postal code Country Position/Affiliation
Nairobi 47855 Kenya KEMRI Centre for Respiratory Disease Research CRDR Kenyatta National Hospital
Role Name Email Phone Street address
Public Enquiries Medical Director MPAG Medical Director MPAG info@molecularpartners.com +41447557700 Wagistrasse 14
City Postal code Country Position/Affiliation
Schlieren 8952 Switzerland Medical Director MPAG
Role Name Email Phone Street address
Scientific Enquiries Medical Director MPAG Medical Director MPAG info@molecularpartners.com +41447557700 Wagistrasse 14
City Postal code Country Position/Affiliation
Schlieren 8952 Switzerland Molecular Partners AG
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be available on open access website(s). De-identified individual patient data (IPD) may be shared by sponsor upon receipt of a reasonable request from researchers who provide a methodologically sound proposal, in accordance with the described key access criteria. Study Protocol Upon completion of the study, grant of the marketing authorization and in case of receipt by sponsor of a reasonable request, sponsor will perform an assessment whether the key access criteria are met. Requests for sharing of IPD will be assessed by sponsor on a case by case - basis in accordance with applicable laws (including data protection laws) and consent provided by patients under the Informed Consent Form. To gain access, data requestors will need to sign a data access agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Summary results will be available on open access website(s). No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information