Status:
WITHDRAWN
DYNAMIC Study (DoxycYcliNe AMbulatoIre COVID-19)
Lead Sponsor:
Nantes University Hospital
Conditions:
COVID19
Eligibility:
All Genders
46+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare a treatment with doxycycline vs a placebo as soon as the patient is confirmed COVID-19 + and before the onset of oxygen dependence with the aim of reducing or even a...
Eligibility Criteria
Inclusion
- Man or woman \> 45 years old.
- Patient with a positive SARS-CoV-2 PCR
- Patient with ENT and / or respiratory symptoms, without hospitalization criteria (no dyspnea, respiratory rate \<22 / min, SaO2 ≥ 94% in ambient air), or digestive signs.
- Patient with at least one of the following risk factors for unfavorable outcome:
- 70 years, BMI\> 30, cardiovascular history (stroke, coronary artery disease, complicated hypertension, cardiac surgery, NYHA III or IV heart failure), respiratory pathology likely to decompensate during viral infection respiratory failure, unbalanced and / or complicated diabètes, respiratory pathology likely to decompensate in the event of of viral infection, patients with renal insufficiency chronic dialysis, .cancer patients under treatment.
Exclusion
- Lactose-intolerant patients
- Patient needing immediate hospitalization for any medical reason
- Patient having more than 5 days of clinical symptoms at the inclusion visit
- Patients with a history of allergy to tetracyclines
- Pregnant or lactating women
- Patients participating in another clinical trial
- Patients with photosensitive skin pathology
- Patients treated with anticoagulant
- Patients treated with oral retinoids: isotretinoin, alitretinoin, acitretin
- Patients treated with vitamin A Patients treated with systemic antibiotics for the duration of treatment
- Patients treated with barbiturates, carbamazepine or phenytoin
- Patients with treatment that may have an effect on COVID-19 infection: chloroquine, hydroxychloroquine, remdesivir, ganciclovir, acyclovir, ribavirin, lopinavir-ritonavir
- Patients under guardianship or trusteeship or in safeguard of justice
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04371952
Start Date
February 1 2021
End Date
February 1 2021
Last Update
April 20 2022
Active Locations (6)
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1
CHU Avicenne - APHP
Bobigny, France, 93009
2
CHU Bordeaux
Bordeaux, France, 33075
3
CHU Caen
Caen, France, 14033
4
CHU Dijon
Dijon, France, 21079