Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
NCT ID:
NCT04343651
Group ID:
EG000
Title:
Placebo
Description:
Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
* No signs of a more serious lower airway disease AND
* RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
Moderate Illness:
* Diagnosed with COVID-19 by a standardized RT-PCR assay AND
* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
* Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
28
Other Number Affected:
12
Other Number At Risk:
28
Study:
NCT04343651
Results Section:
NCT04343651
Adverse Events Module:
NCT04343651