COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006082-11/BG

Invivyd Inc. - Clinical Trial Information Desk

clinicaltrials@invivyd.com

2021-06-15

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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 or other immunodeficiency due to underlying illness or immunosuppressant medication x. Other immunodeficiency due to underlying illness or immunosuppressant medication xi. Substance use disorder xii. Pregnant (Ph 3 only: after Ph results review 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 participants assigned female sex at birth is defined as consistent and correct use of a highly effective locally approved contraceptive method in accordance with local regulations for contraceptive use in clinical trial participants. 8. Has been assigned male sex at birth with partner(s) of childbearing potential and agree to use contraception, per local regulations, through 6 months after dosing. If their partner is pregnant, males must agree to use a condom. No sperm donation is permitted through 6 months after dosing. 9. Is able to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or guardian/[LAR]) based on the assessment of the investigator. 10. Is able and willing to provide informed consent. An LAR may be used in Phase 2 and 3 only in cases where inclusion criterion 9 is able to be fulfilled. In the case of adolescents, informed assent must also be obtained as required by local guidelines.

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.

2

Invivyd Inc.

12

100

Brazil;South Africa;Poland;Bulgaria;Romania;Germany;Greece;Ukraine;United States

Mild disease at enrollment

1: Mild disease at enrollment

146

Phase 2/3 - 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)

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 31, "treatment_name": "Adg20", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]