Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation (NCT04356495) | Clinical Trial Compass
CompletedPhase 2/3
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
France412 participantsStarted 2020-07-29
Plain-language summary
In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.
Who can participate
Age range
50 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:
* Clinical picture suggestive of COVID-19 dated 7 days or less.
* Positivity of a test proving an acute SARS-CoV-2 infection, according to current recommendations.
* Absence of criteria for hospitalization or oxygen therapy according to current recommendations.
* Age :
* greater than or equal to 60 years of age without any risk factor
* or between 50 and 59 years of age and the presence of at least one of the following risk factors :
* Arterial hypertension under treatment (all stages)
* Obesity (BMI ≥30 kg/m2)
* Diabetes under treatment (all types)
* Ischemic heart disease (all stages)
* Heart failure (all stages)
* Stroke History
* Chronic Obstructive Pulmonary Disease (all stages)
* Stage 3 chronic renal failure (30 ≤ Estimated GFR \< 60 mL/min/1.73 m²)
* Malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago.
* Immunodeficiency
* of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids \> 15 mg/d of prednisone equivalent taken for at least 2 months);
* HIV infection with CD4\<200/mm3.
* Valid, ambulatory person, fully able to understand the issues of the trial
* Beneficiary of a Social Security scheme
* Signed informed consent
Exclusion Criteria:
* Asymptomatic person
* Inability to make a decision to participate (dementia, person under legal protection, cur…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event