Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2021-02-01
2021-02-01
Brief Summary
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Three criteria support the rational use of tetrcycline in COVI-19 (1) The coronaviruses is known to bind to metalloproteases (MMPs) of the host, in particular to ensure viral survival. Tetracyclines are known to chelate zinc from MMPs. Their chelating activity may help inhibit COVID19 infection by limiting its ability to replicate in the host. (2) Tetracyclines may also be able to inhibit the replication of positive-polarity single-stranded RNA viruses, such as COVID19 (demonstrated on the dengue virus). (3) In addition, tetracyclines are modulators of innate immunity (anti-inflammatory activity), a property used in the treatment of inflammatory skin diseases for many years. These modulating effects are noted on several targets of innate immunity: They can decrease the expression of NFKB, the release of inflammatory cytokines such as TNF-α, IL-1β and IL-6, inhibit granulomas inflammatory and free radical release.
Tetracyclines could therefore participate in limiting the cytokine release induced by COVID19. Their lipophilic nature and their strong pulmonary penetration could allow them to inhibit viral replication.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Doxycycline 100mg
Doxycycline capsule containing 2 tablets doxycycline 100mg over-encapsulated. Doxycycline is given at 200 mg once a day and administered per os during 2 weeks
Doxycycline
comparison of doxycycline 200 mg/day to placebo
Doxycycline placebo
Doxycycline Placebo capsule 200 mg, containing 1 capsule of a marketed placebo = RODAEL placebo ( lactose, 380 mg / capsule). Doxycycline placebo is given once a day and administered per os during 2 weeks
Placebo
Placebo : lactose, 380 mg/gélule
Interventions
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Doxycycline
comparison of doxycycline 200 mg/day to placebo
Placebo
Placebo : lactose, 380 mg/gélule
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
46 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Avicenne - APHP
Bobigny, , France
CHU Bordeaux
Bordeaux, , France
CHU Caen
Caen, , France
CHU Dijon
Dijon, , France
CHU Grenoble
Grenoble, , France
CHU Nantes
Nantes, , France
Countries
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Other Identifiers
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RC20_0191
Identifier Type: -
Identifier Source: org_study_id
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