Treatment of symptomatic patients with moderate to severe coronavirus disease 2019 (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: COR-101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: COR-101
Current Sponsor code: COR-101
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
CORAT Therapeutics GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient must be willing and able to give informed consent to participate in the study and to adhere to the procedures stated in the protocol. 2. The patient is male or female adult =18 years (as per local laws) of age at the time of giving informed consent. 3. The patient is admitted to a hospital (93% or = 93% on room air at sea level or, c. heart rate =90 or = 125 beats per minute for moderate or severe illness, respectively d. No clinical signs indicative of critical COVID-19 Please note: To standardize the assessment of COVID-19 severity, respiratory rate, SpO2, and heart rate will be measured when the patient is on room air (ie, no supplemental oxygen) and at rest for at least 5 minutes. 5. The patient agrees to not participate in another clinical study of antibody therapy from screening until Day 80, and of any other investigational drug expected to interfere with the study endpoints from screening until Day 28. 6. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with one of the following contraception requirements from the time of first dose of screening until at least 80 days after the last dose of study medication: a. Vasectomy with documentation of azoospermia. b. Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 80 days after the last dose of study medication) c. Male condom plus partner use of one of the contraceptive options below: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches. 7. WOCBP must agree to comply with one of the following contraception requirements from the time of screening until at least 80 days after the last dose of study medication: a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: i. oral ii. intravaginal iii. transdermal b. progestogen-only hormonal contraception associated with inhibition of ovulation : i. oral ii. injectable iii. implantable c. intrauterine device (IUD) d. intrauterine hormone-releasing system ( IUS) e. bilateral tubal occlusion f. vasectomised partner with documentation of azoospermia g. sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 80 days after the last dose of study medication)). The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (eg, male sterility), the investigator will determine what is consistent and correct use. The investigator is responsible for ensuring that patients underst
Exclusion criteria
Exclusion criteria: 1. The patient, in the opinion of the investigator, is not likely to survive for >48 hours beyond Day 1. 2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1. a. Asymptomatic COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test but not experiencing symptoms. b. Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing symptoms of mild illness (especially no dyspnea) but no clinical signs indicative of moderate, severe, or critical COVID-19. c. Critical COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing at least one of the following: shock defined by systolic blood pressure 20 L/min with fraction of delivered oxygen =0.5), non-invasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation), and/or multi-organ dysfunction/failure. 3. The patient has a Child Pugh score >A. 4. The patient has an estimated glomerular filtration rate (eGFR) 120 kg 12. A female patient who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) or prior to dosing on Day 1 (by urine) as determined by human chorionic gonadotrophin tests. 13. The patient is planning to donate or bank ova or sperm from Day 1 until 80 days after the last dose of study drug. 14. The patient has a known history of drug or alcohol abuse within 6 months of study start that would interfere with the patient’s participation in the study. 15. The patient has a history of sensitivity to any of the study drugs or components thereof or a history of drug or other allergy (including systemic anaphylaxis) that, in the opinion of the investigator or medical monitor, would contraindicate their participation. 16. The patient has participated in and/or plan to participate in another clinical study using an investigational product within the following period prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: • To evaluate the safety and tolerability of COR-101 at various dose levels compared to that of the placebo-control (both as add-on therapy to standard of care [SOC]) in hospitalized patients with moderate to severe COVID-19 Part 2: • To evaluate the efficacy and safety of COR-101 compared to that of the placebo-control (both as add-on therapy to SOC) in hospitalized patients with moderate to severe COVID-19;Secondary Objective: Part 1: • To evaluate the preliminary efficacy of COR-101 at various dose levels compared to that of the placebo-control (both as add-on therapy to SOC) in hospitalized patients with moderate to severe COVID-19 • To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of COR-101 at various dose levels compared to that of the placebo-control (both as add-on therapy to SOC) in hospitalized patients with moderate to severe COVID-19. Part 2: • To assess PK, PD, and immunogenicity of COR-101 in hospitalized patients with moderate to severe COVID-19 ;Primary end point(s): Part 1: - Incidence of adverse events (AEs): Serious adverse events (SAE), treatment-emergent adverse events (TEAEs), mortality, and AEs requiring medical intervention until Day 28. Part 2: The primary efficacy endpoint of Part 2 is: - Proportion of patients with disease progression on Days 6, 14, 21, and 28, defined as the proportion of patients who are not alive or have respiratory failure. Respiratory failure is defined as the need for invasive or non-invasive mechanical ventilation, high-flow oxygen, or ECMO until Day 6, 14, 21, and 28. The primary safety endpoints of Part 2 are: - Incidence of (AEs): (SAE), (TEAEs), mortality, and AEs requiring medical intervention until Day 28. ;Timepoint(s) of evaluation of this end point: Incidence of AE (also AE requiring medical intervention), SAE, TEAEs, and mortality: until Day 28 Proportion of patients with disease progression: until Days 6, 14, 21 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints of Part 1 are: • Proportion of patients with disease progression on Days 6, 14, 21, and 28, defined as the proportion of patients who are not alive or have respiratory failure. Respiratory failure is defined as the need for invasive or non-invasive mechanical ventilation, high-flow oxygen, ECMO until Days 6, 14, 21, and 28. • Proportion of patients with disease resolution, as evidenced by resolution of symptoms at Days 6, 14, 21, and 28. • Proportion of patients with viral clearance at Days 6, 14, 21 and 28. • Mortality at Day 28. • Mortality at Day 80. • Proportion of patients free of respiratory failure on Day 28. • Percentage of patients reporting each severity rating on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale on Days 6, 14, 21, and 28. • Change in National Early Warning Score 2 (NEWS2) from baseline on Days 6, 14, 21, and 28. • Time to negative RT-PCR for SARS-CoV-2. The secondary PK endpoint of Part 1 is: • COR-101 serum concentrations and PK parameters including Cmax, tmax, AUC0-t, AUC0-8, t½, ?z, %AUCextra, MRT, CL, Vz after a single dose. The secondary PD endpoint of Part 1 is: • Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR on Days 2, 4, 6, 14, 21, 28, and 80. The secondary safety endpoint of Part 1 is: • AEs including SAEs, and Grade 3 and 4 AEs during follow-up period from Day 28 through Day 80. The secondary efficacy endpoints of Part 2 are: • Proportion of patients with disease resolution, as evidenced by resolution of symptoms at Days 6, 14, 21 and 28 • Proportion of patients with disease resolution, as evidenced by viral clearance at Days 6, 14, 21 and 28 • Mortality at Day 28 • Mortality at Day 80 • Proportion of patients free of respiratory failure on Day 28 • Percentage of patients reporting each severity rating on the NIAID 8-point ordinal scale on Days 6, 14 | — |
Countries
Germany
Contacts
Public ContactAndreas Herrmann
CORAT Therapeutics GmbH
Outcome results
None listed