COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol
United States122 participantsStarted 2021-04-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Outpatient setting
. Age ≥ 18 years and ≤ 80 years at the time of the assessment
. Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
. Initial diagnosis of COVID-19 disease as defined by an FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 with no more than 72 hours from the initial swab used in the diagnosis to the time of commencing informed consent.
. At baseline, at least two symptoms should have mild or higher severity score, where at least one of the mild symptoms is not cough, fatigue, or loss of smell/taste OR at least one symptom has a moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS).
. Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 2 trial for COVID-19 outpatients that has already completed — can you tell me what the results showed for how quickly symptoms resolved and whether the treatments reduced viral shedding, and how that might apply to my situation?
2Since this trial studied outpatient COVID-19 treatment specifically, does that match my current condition, and would the treatments that were tested here be something worth considering in my care plan?
3Because this was a Phase 2 study, the safety and effectiveness data may still be limited — are there now Phase 3 trials or already-approved treatments with stronger evidence that you'd recommend instead?
4The trial measured two different things — viral shedding and time until symptoms fully resolved — do you think one of those outcomes matters more for someone in my specific situation, and did the trial results show meaningful improvement in either?
5Since recruitment is completed and the trial is no longer enrolling, are there any follow-up studies or related trials still open that I should know about, or is standard treatment the clearest path forward for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Other inclusion criteria specific to the investigational product that may, in the eyes of the investigator, be deemed necessary.
Exclusion criteria
. At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission.
. Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators.
. Participant yields a positive urine pregnancy test at screening.
. Participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
. Participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus \[HIV\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
. Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
. Has liver impairment greater than Child Pugh A.
. Has a history of alcohol or drug abuse in the previous 6 months.