COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62557

Rashmi Chitgupi

rashmi.chitgupi@ppd.com

2021-12-07

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Each participant must meet all of the following criteria to be enrolled in this <br/ > study: <br/ > 1. Age: <br/ > a. Phase 2: Is an adult aged 18 years and above <br/ > b. Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to <br/ > 17 years (inclusive) and weighing �40 kg at the time of screening <br/ > Note: Adolescent enrollment will open only upon sponsor communication to sites <br/ > after review of Phase 2 data by the iDMC. <br/ > 2. Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular <br/ > diagnostic assay obtained within 5 days prior to randomization. <br/ > Note: A historical record of a positive result from a test conducted within 5 days prior to <br/ > randomization is acceptable. SARS-CoV-2 antibody testing cannot be used for study <br/ > eligibility. <br/ > 3. Has had initial onset of one or more of the following self-reported COVID-19-related <br/ > signs or symptoms within 5 days prior to randomization: <br/ > a. measured temperature �38°C (100.4°F) <br/ > b. subjective fever (feeling hot or feverish) <br/ > c. chills (shivering) <br/ > d. cough <br/ > e. sore throat <br/ > f. congestion (stuffy or runny nose) <br/ > g. shortness of breath or difficulty breathing with exertion worse than usual <br/ > h. muscle or body aches <br/ > i. fatigue (low energy or tiredness) <br/ > j. headache <br/ > k. loss of taste or smell <br/ > l. nausea or vomiting <br/ > m. diarrhea <br/ > 4. Has one or more of the following COVID-19-related signs or symptoms on the day of <br/ > randomization: <br/ > a. measured temperature �38°C (100.4°F) <br/ > b. subjective fever (feeling hot or feverish) <br/ > c. chills (shivering) <br/ > d. cough <br/ > e. sore throat <br/ > f. congestion (stuffy or runny nose) <br/ > g. shortness of breath or difficulty breathing with exertion worse than usual <br/ > h. muscle or body aches <br/ > i. fatigue (low energy or tiredness) <br/ > j. headache <br/ > k. loss of taste or smell <br/ > l. nausea or vomiting <br/ > m. diarrhea <br/ > 5. Is at high risk of disease progression defined as: <br/ > a. Age >55 years <br/ > b. Age 18 to �55 years with one or more preexisting medical conditions as follows <br/ > i. Obesity (body mass index [BMI] �30 kg/m2) <br/ > ii. Diabetes (Type 1 or Type 2) <br/ > iii. Chronic kidney disease (eGFR calculated by Modification of Diet in Renal <br/ > Disease [MDRD] of 59 mL/min/1.73 m2 or less, including end-stage renal <br/ > disease on hemodialysis) <br/ > iv. Chronic lung disease (emphysema/chronic obstructive pulmonary disease, <br/ > chronic bronchitis, interstitial lung disease [including idiopathic <br/ > pulmonary fibrosis] or cystic fibrosis) <br/ > v. Cardiac disease (heart failure, coronary artery disease, or <br/ > cardiomyopathies) <br/ > vi. Sickle cell disease or thalassemia <br/ > vii. Solid organ or blood stem cell transplant recipients <br/ > viii. Other immunodeficiency due to underlying illness or immunosuppressant <br/ > medication (eg, corticosteroids �20 mg/day prednisone or equivalent) <br/ > ix. Down Syndrome <br/ > x. Stroke or cerebrovascular disease, which affects blood flow to the brain <br/ > xi. Substance use disorder <br/ > xii. Pregnant (Phase 3 only, Enrollment of participants who are pregnant may <br/ > only open upon sponsor communication to sites after review of Phase 2 <br/ > data by the iDMC) <br

Participants meeting any of the following criteria will be excluded from the study: <br/ > 1. Is currently hospitalized or in the opinion of the investigator requires urgent medical <br/ > attention or is anticipated to require hospitalization within 48 hours of randomization. <br/ > 2. Has oxygen saturation (SpO2) â?¤93% on room air at sea level or ratio of arterial oxygen <br/ > partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <br/ > <300 mmHg, respiratory rate â?¥30 per minute, or heart rate â?¥125 per minute. <br/ > 3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the <br/ > opinion of the investigator anticipated impending need for mechanical ventilation. <br/ > 4. Has a history of a positive SARS-CoV-2 antibody serology test. Note: serology testing is <br/ > not required for study eligibility, exclusion criterion is based on known history only. <br/ > 5. Has participated, within the last 30 days, in a clinical study involving an investigational <br/ > intervention. If the previous investigational intervention has a long half-life, 5 half-lives or <br/ > 30 days, whichever is longer, should have passed. <br/ > 6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients. <br/ > 7. Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who <br/ > recovered from COVID-19 any time prior to participation in the study. <br/ > 8. Has a known active co-infection (eg, influenza, urinary tract infection, etc). <br/ > 9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of <br/ > the investigator, might confound the results of the study or pose an additional risk to the <br/ > participant by their participation in the study including but not limited to any co-morbidity <br/ > requiring surgery or conditions considered life-threatening within 29 days. <br/ > 10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or <br/ > platelet disorder), or prior history of significant bleeding or bruising following IM <br/ > injections or venipuncture. <br/ > 11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) <br/ > who is an investigator or site or sponsor staff (or designee) directly involved with the <br/ > study.

2

Adagio Pharmaceuticals Inc

18

99

Argentina;Brazil;India;Bulgaria;Germany;Greece;Hungary;Mexico;Peru;Poland;Republic of Moldova;Romania;South Africa;United Kingdom;Ukraine

Mild disease at enrollment

1: Mild disease at enrollment

1084

To evaluate the efficacy; safety and tolerability of ADG20 <br/ >compared to placebo in the treatment of mild <br/ >or moderate COVID-19 in participants at <br/ >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. <br/ >The safety and tolerability of ADG20 will be assessed through Day 29 based on : <br/ >-The incidence of TEAEs <br/ >-Incidence of solicited injection site reactions through Day 4 <br/ >- Changes from baseline in clinical laboratory tests <br/ >- Changes from baseline in vital signs

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

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 597, "treatment_name": "Human immunoglobulin", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]