A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04402060|
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : December 19, 2020
The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation.
It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 has been designed to inhibit or block activation of part of the complement pathway, and potentially reduce inflammation in the lungs.
Part 1 of the study is open-label to evaluate safety; all participants will receive APL-9 plus standard of care. Part 2 of the study is double-blind, randomized; participants will receive either APL-9 or the vehicle-control plus standard of care.
|Condition or disease||Intervention/treatment||Phase|
|COVID Covid-19 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Severe Acute Respiratory Syndrome Coronavirus 2 Sars-CoV2 Ards Acute Respiratory Distress Syndrome||Drug: APL-9 Other: Vehicle Control||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19|
|Actual Study Start Date :||May 28, 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
|Experimental: 180 mg APL-9 IV plus SOC||
Complement (C3) Inhibitor
|Placebo Comparator: Isotonic saline||
Other: Vehicle Control
Normal saline of equal volume to active arm
- Cumulative incidence of treatment-emergent serious adverse events and treatment-emergent adverse events. [ Time Frame: Day 1 through Day 51 ]
- Hospital length of stay [ Time Frame: Day 1 through Day 21 ]
- Any cause of mortality [ Time Frame: Day 1 through day 58 ]
- Sequential Organ Failure Assessment [ Time Frame: Day 1 through day 21 ]The minimum value is 0 and maximum value is 24. The higher a score the worse the outcome.
- Total duration of mechanical ventilation and/or oxygen therapy [ Time Frame: Day 1 through day 21 ]
- Total duration of oxygen therapy [ Time Frame: Day 1 through day 21 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402060
|Contact: Apellis Clinical Trial Information Linefirstname.lastname@example.org|