COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol (COPPS)
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|ClinicalTrials.gov Identifier: NCT04662060|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2020
Last Update Posted : May 27, 2022
The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients.
COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Acebilustat Drug: Placebo||Phase 2|
The platform study allows investigational products with objectives either: evaluating viral shedding (Virology Domain); and COVID-19 related Clinical Outcomes (Clinical Domain).
The primary objective for investigational products within the Viral Domain is:
A. To evaluate the efficacy of each therapeutic intervention in addition to standard supportive care (SSC) compared with SSC in reducing viral shedding of SARS-CoV-2 virus in outpatients with COVID-19 disease.
The primary objective for investigational products within for the Clinical Domain is:
B. To evaluate the efficacy of each therapeutic intervention in addition to SSC as compared to SSC in improving sustained clinical outcomes in outpatients with COVID-19 disease.
Secondary objectives are:
The objective of the non-assigned domain an investigational product is under.
- If under Clinical Domain, reduction in viral shedding.
- If under Viral Domain, time to resolution of symptoms.
- To evaluate the efficacy of each therapeutic intervention in reducing SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease.
- To assess the development of antibodies against SARS-CoV-2
- To evaluate the safety and tolerability of each therapeutic intervention compared with placebo (supportive care).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19|
|Actual Study Start Date :||April 23, 2021|
|Actual Primary Completion Date :||May 3, 2022|
|Estimated Study Completion Date :||July 2022|
Participants are randomized to receive acebilustat for 28 days.
100 mg capsule administered orally once daily
Placebo Comparator: Matching Placebo
Participants are randomized to receive placebo to match acebilustat for 28 days.
Placebo to match acebilustat administered orally once daily
- For Clinical Domain: Time-to-sustained-resolution [ Time Frame: 28 days ]Time from randomization to sustained symptom resolution assessed over a 28-day period. Resolution is defined as the first day where no symptoms are self-reported on all succeeding days through and including day 28, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.
- For the Viral Domain: Change in Viral Shedding [ Time Frame: 10 days ]Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab RT-PCR data after transformation using a referenced standard curve.
- Time to viral cessation [ Time Frame: 28 days ]Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs.
- Time to first resolution [ Time Frame: 28 days ]Defined as the first study day where no symptoms are self-reported, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.
- Time to full resolution [ Time Frame: 28 days ]Defined as the study day where no symptoms are first self-reported.
- Indicator of SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease. [ Time Frame: 28 days ]
- Indicator participant has developed antibodies to SARS-CoV-2 [ Time Frame: 28 days ]
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): NCT04662060
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Angela Rogers, MD||Stanford University|
|Principal Investigator:||Joseph Levitt, MD, MS||Stanford University|