COVID-19 MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862
Conditions
Sponsors
Adagio Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: a. Ph 2: Is an adult aged 18 years and above b. Ph 3: Is an adult aged 18 years and above or is an adolescent aged 12-17 years (inclusive) and weighing =40 kg at the time of screening 2. Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization 3. Has had initial onset of one or more of the following self-reported COVID-19-related signs or symptoms within 5 days prior to randomization: (temperature =38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea) 4. Has one or more of the following COVID-19-related signs or symptoms on the day of randomization (temperature =38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea) 5. Is at high risk of disease progression defined as: a. Age >55 years b. Age 18 to =55 years with one or more stable preexisting medical conditions as follows i. Obesity [BMI = 30 kg/m2] ii. Diabetes (Type 1 or Type 2) iii. Chronic kidney disease iv. Chronic lung disease v. Cardiac disease vi. Sickle cell disease or thalassemia vii. Solid organ or blood stem cell transplant recipients viii. Other immunodeficiency due to underlying illness or immunosuppressant medication ix. Down Syndrome x. Stroke or cerebrovascular disease, which affects blood flow to the brain xi. Substance use disorder xii. Pregnant (Phase 3 only; after review Ph2 data by iDMC) c. Age 12 to 17 years (inclusive) with one or more preexisting medical conditions as follows i. BMI >85th percentile for age and gender based on CDC growth charts ii. Diabetes (Type 1 or 2) iii. Chronic kidney disease iv. Sickle cell disease or thalassemia v. Congenital or acquired heart disease vi. Neurodevelopmental disorders vii. A medically related technological dependence viii. Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control ix. Solid organ or blood stem cell transplant recipients x. Other immunodeficiency due to underlying illness or immunosuppressant medication xi. Substance use disorder xii Pregnant (Ph 3 only: enrollment only after Ph2 data reviewed by iDMC) 6. Has been assigned female sex at birth and is of nonchildbearing potential. A female participant who is not of reproductive potential is eligible without requiring the use of contraception and pregnancy testing is not required. This includes female participants who have not undergone menarche or who are documented to be surgically sterile or postmenopausal. Follicle stimulating hormone is not required in postmenopausal females with amenorrhea for >2 years. 7. Has been assigned female sex at birth and is of childbearing potential and fulfills all the following criteria: a. Has a negative urine or serum pregnancy test at Screening b. Has practiced adequate contraception for or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1) c. Has agreed to continue adequate contraception for sexual activity that could lead to pregnancy through 6 months following study drug administration d. Is not currently breastfeeding Adequate contraception for particip
Exclusion criteria
Exclusion criteria: 1. Is currently hospitalized or in the opinion of the investigator requires urgent medical attention or is anticipated to require hospitalization within 48 hours of randomization 2. Has oxygen saturation (SpO2) =93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300 mmHg, respiratory rate =30 per minute, or heart rate =125 per minute. 3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the opinion of the investigator anticipated impending need for mechanical ventilation. 4. Has a history of a positive SARS CoV 2 antibody serology test. Note: serology testing is not required for study eligibility, exclusion criterion is based on known history only. 5. Has participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients. 7. Has received a SARS CoV 2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID 19 any time prior to participation in the study. 8. Has a known active co infection (eg, influenza, urinary tract infection, etc). 9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study including but not limited to any co-morbidity requiring surgery or conditions considered life-threatening within 29 days. 10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. 11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) who is an investigator or site or sponsor staff (or designee) directly involved with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID 19 in participants at high risk of disease progression - To evaluate the safety and tolerability of ADG20 compared to placebo through Day 29 in participants with mild and moderate COVID-19 and high risk of disease progression;Secondary Objective: - To evaluate the effect of ADG20 on the following clinical parameters in participants with mild or moderate COVID 19 and high risk of disease progression o Severity of COVID-19 o COVID-19 related emergency room visits, COVID-19 related hospitalizations, or all cause death o COVID-19 related medically attended visits o Time to sustained recovery of COVID-19 symptoms o All cause mortality - To evaluate the effect of ADG20 on SARS-CoV-2 viral load and clearance in participants with mild or moderate COVID-19 and high risk of disease progression - To evaluate the safety and tolerability of ADG20 compared to placebo through Month 14 in participants with mild or moderate COVID-19 and high risk of disease progression - To evaluate the PK of ADG20 following IM administration - To evaluate the immunogenicity (ADAs) to ADG20 - To evaluate the emergence of resistance to ADG20 ;Primary end point(s): - COVID-19 related hospitalization or all-cause death through Day 29 - Assessment of safety through Day 29 based on: o The incidence of TEAEs o Incidence of solicited injection site reactions through Day 4 o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) o Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure) ;Timepoint(s) of evaluation of this end point: - day 29 - day 4 and day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - day 29 - days 29, 60, 90 - day 7 - day 1, day 29 - days 3, 5, 8, 11, 14 - days 5, 7, 11, 14, 21, 29 - day 7, 11, 14, 21, 29 - month 14 Exploratory - day 29 - day 60, 90, and month 6;Secondary end point(s): o Severe/critical COVID-19 or all-cause death through Day 29 o COVID 19-related emergency room visits, COVID-19 related hospitalization, or all-cause death through Day 29 o COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29 o Time to sustained recovery defined as sustained improvement or resolution of COVID 19 symptoms through Day 29 o All cause mortality through Day 29, Day 60, and Day 90 o Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Day 7 (±1) assessed by RT qPCR from NP samples o Viral load >5 (log10 copies/mL) on Day 7 (±1) based on nasopharyngeal sampling (Ph 3) o Duration of SARS-CoV-2 viral shedding from Day 1 through Day 29 assessed by RT-qPCR from saliva samples o Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Days 3, 5, 7, 11, and 14 assessed by RT-qPCR from saliva samples o SARS-CoV-2 viral clearance (Days 5, 7, 11, 14, 21, and 29) assessed by RT-qPCR from saliva samples (and NP samples for Day 7) o SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples from baseline to Day 7, 11, 14, 21 and 29 - Assessment of safety through Month 14 based on: o The incidence of TEAEs o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) o Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure) - PK parameters of ADG20: As data permit, Cmax, Tmax, AUC 0-last, AUC 0-inf, CL, Vd, and T1/2. Additional PK parameters may be calculated as data permit - Incidence of ADAs against ADG20 - Genotypic characterization of viral isolates for re | — |
Countries
Argentina, Brazil, Bulgaria, Chile, Germany, Greece, Hungary, Mexico, Peru, Poland, South Africa, Turkey, Ukraine
Contacts
Public ContactClinical Trial Information Desk
Adagio Therapeutics Inc.
Outcome results
None listed