Overview

Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation

Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Bordeaux
Collaborator:
University of Bordeaux
Treatments:
Ciclesonide
Hydroxychloroquine
Imatinib Mesylate
Interferon beta-1b
Interferon-beta
Interferons
Telmisartan
Criteria
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,
curatorship or guardianship)

- Ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.