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| Name | Class |
|---|---|
| eMed | UNKNOWN |
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A prospective monitoring study for those individuals treated with Paxlovid
The purpose of this study is to understand the epidemiology and pathophysiology of Paxlovid rebound in patients with acute Covid-19 infection who have been prescribed the Paxlovid per standard of care.
The study will be a collaborative effort between Scripps and eMed, digitally recruiting 800 participants who have tested positive for Covid-19 and have agreed to be prescribed Paxlovid on the eMed platform.
The vision of the study is to understand Paxlovid rebound and ultimately inform management of acute Covid-19 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paxlovid Cohort | Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 1 will include 400 participants that opt to take the 5-day course of Paxlovid. Participation will look identical in this study. | ||
| Control Cohort | Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 2, control, will include 400 participants that opt out of taking the 5-day course of Paxlovid. Participation will look identical in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Paxlovid Rebound | Incidence of paxlovid rebound defined as test positivity after a documented negative rapid antigen test post 5 day course of Paxlovid | 16 day period |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptomatology long term | Understand the long term impact of paxlovid rebound on symptomatology | 6 month period |
| Number of viral rebound | Differences in viral rebound between control and paxlovid group |
Inclusion Criteria:
Exclusion Criteria:
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The study population will be obtained from the eMed platform and will consist of participants that tested positive using an eMed rapid antigen test, who underwent a telemedicine visit and opted in or out of receiving a prescription for a 5-day course of Paxlovid.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Pandit, MD | Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Research Institute | San Diego | California | 92126 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 16 day period |
| Number of grouped symptomatology | Differences in symptomatology between control and paxlovid group. | 16 day period |
| Immune profile | Differences in immune profile between control and paxlovid group | 6 month period |
| Viral Evolution | Differences in viral evolution between control and paxlovid group | 6 month period |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |