Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B342- Coronavirus infection, unspecified
Conditions
Interventions
Intervention1: ADG20 (fully human monoclonal immunoglobulin G (IgG)1 antibody IM): Route of administration: Participants will receive a single dose of ADG20 as Intramuscular injection on Day 1.
Durati
Sponsors
Adagio Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: Each participant must meet all of the following criteria to be enrolled in this study: 1. Age: a. Phase 2: Is an adult aged 18 years and above b. Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing >=40 kg at the time of screening Note: Adolescent enrollment will open only upon sponsor communication to sites after review of Phase 2 data by the iDMC. 2. Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization. Note: A historical record of a positive result from a test conducted within 5 days prior to randomization is acceptable. SARS-CoV-2 antibody testing cannot be used for study eligibility. 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: a. measured temperature >=38°C (100.4°F) b. subjective fever (feeling hot or feverish) c. chills (shivering) d. cough e. sore throat f. congestion (stuffy or runny nose) g. shortness of breath or difficulty breathing with exertion worse than usual h. muscle or body aches i. fatigue (low energy or tiredness) j. headache k. loss of taste or smell l. nausea or vomiting m. diarrhea 4. Has one or more of the following COVID-19-related signs or symptoms on the day of randomization: a. measured temperature >=38°C (100.4°F) b. subjective fever (feeling hot or feverish) c. chills (shivering) d. cough e. sore throat f. congestion (stuffy or runny nose) g. shortness of breath or difficulty breathing with exertion worse than usual h. muscle or body aches i. fatigue (low energy or tiredness) j. headache k. loss of taste or smell l. nausea or vomiting m. diarrhea 5. Is at high risk of disease progression defined as: a. Age >55 years b. Age 18 to i. Obesity (body mass index [BMI] >=30 kg/m2) ii. Diabetes (Type 1 or Type 2) iii. Chronic kidney disease (eGFR calculated by Modification of Diet in Renal Disease [MDRD] of 59 mL/min/1.73 m2 or less, including end-stage renal disease on hemodialysis) iv. Chronic lung disease (emphysema/chronic obstructive pulmonary disease, chronic bronchitis, interstitial lung disease [including idiopathic pulmonary fibrosis] or cystic fibrosis) v. Cardiac disease (heart failure, coronary artery disease, or cardiomyopathies) 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 (eg, corticosteroids >=20 mg/day prednisone or equivalent) ix. Down Syndrome x. Stroke or cerebrovascular disease, which affects blood flow to the brain xi. Substance use disorder xii. Pregnant (Phase 3 only; Enrollment of participants who are pregnant may only open upon sponsor communication to sites after review of Phase 2 data by the iDMC) c. Age 12 to 17 years (inclusive) with one or more p
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 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) partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) =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 |
|---|---|
| To evaluate the efficacy, safety and tolerability of ADG20 compared to placebo in the treatment of mild or moderate COVID-19 in participants at high risk of disease progressionTimepoint: The efficacy of ADG20 will be assessed through Day 29 with endpoints of COVID-19-related hospitalization or all-cause death. The safety and tolerability of ADG20 will be assessed through Day 29 based on : -The incidence of TEAEs -Incidence of solicited injection site reactions through Day 4 - Changes from baseline in clinical laboratory tests - Changes from baseline in vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 progressionTimepoint: Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Day 7 (±1) Viral load 5 (log10 copies/mL) on Day 7 (±1) Duration of SARS-CoV-2 viral shedding from Day 1 through Day 29 Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Days 3, 5, 7, 11, and 14 assessed from saliva SARS-CoV-2 viral clearance (Days 5, 7, 11, 14, 21, and 29) SARS-CoV-2 viral load AUC assessed from baseline to Day 7, 11, 14, 21 and 29;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 Severity of COVID-19 COVID-19-related emergency room visits, COVID-19-related hospitalizations, or all-cause death COVID-19-related medically attended visits Time to sustained recovery of COVID19 symptoms All-cause mortalityTimepoint: Severe/critical COVID-19 or all-cause death through Day 29 COVID-19-related emergency room visits, COVID-19 related hospitalization, or all-cause death through Day 29 COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29 Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms through Day 29 All-cause mortality through Day 29, Day 60, and Day 90;To evaluate the emergence of resistance to ADG20 Timepoint: Genotypic characterization of viral isolates for reduced susceptibility to ADG20, with phenotypic evaluation as appropriate;To evaluate the immunogenicity (ADAs) to ADG20 Timepoint: Incidence of ADAs against ADG20;To evaluate the PK of ADG20 following IM administration Timepoint: PK parameters of ADG20: As data permit, Cmax, Tmax, AUC0-last, AUC0-inf, CL, Vd, and T1/2. Additional PK parameters may be calculated as data perm | — |
Countries
Argentina, Brazil, Bulgaria, Georgia, Germany, Greece, Hungary, India, Mexico, Peru, Poland, Republic of Moldova, Romania, South Africa, Ukraine
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed