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.
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: 1. The objective of the non-assigned domain an investigational product is under. 1. If under Clinical Domain, reduction in viral shedding. 2. If under Viral Domain, time to resolution of symptoms. 2. 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. 3. To assess the development of antibodies against SARS-CoV-2 4. To evaluate the safety and tolerability of each therapeutic intervention compared with placebo (supportive care).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
100 mg capsule administered orally once daily
Placebo to match acebilustat administered orally once daily
Stanford University
Stanford, California, United States
For Clinical Domain: Time-to-sustained-resolution
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.
Time frame: 28 days
For the Viral Domain: Change in Viral Shedding
Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab. Viral load (nucleic acid) was assessed by RT-PCR Ct over time, and is reported here as the average change in Ct values per day. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
Time frame: 10 days
Time to Viral Cessation
Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs.
Time frame: 28 days
Time to First Resolution
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 frame: 28 days
Time to Full Resolution
Defined as the study day where no symptoms are first self-reported.
Time frame: 28 days
Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease.
Time frame: 28 days
Number of Participants That Developed Antibodies to SARS-CoV-2
Time frame: 28 days
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