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DYNAMIC Study (DoxycYcliNe AMbulatoIre COVID-19) (DYNAMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371952
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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 abolishing the cytokine explosion and thus the evolution towards a serious form of the disease which can lead to death.

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.


Condition or disease Intervention/treatment Phase
COVID19 Drug: Doxycycline Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Doxycycline
comparison of doxycycline 200 mg/day to placebo

Placebo Comparator: 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
Drug: Placebo
Placebo : lactose, 380 mg/gélule




Primary Outcome Measures :
  1. Percentage of Patients with Clinical Respiratory Aggravation [ Time Frame: after at least 48 hours of treatment ]
    Percentage of patients with clinical worsening (SaO2 ≤ 93%) after at least 48 hours of treatment

  2. Percentage of patients hospitalized [ Time Frame: after at least 48 hours of experimental treatment ]
    Percentage of patients hospitalized after at least 48 hours of experimental treatment

  3. Percentage of patients requiring ventilatory assistance [ Time Frame: Day 0 to Day 28 ]
    Percentage of patients requiring ventilatory assistance


Secondary Outcome Measures :
  1. Positive SARS-CoV-2 PCR Test [ Time Frame: Day -1 or day 0 AND Day 7 ]
    Number of positive SARS-CoV-2 PCR tests on D-1 / D0 and D7 (+/- 2 days)

  2. Duration of symptoms [ Time Frame: Day 0 to Day 28 ]
    Duration of symptoms (fever, painful symptoms: headache, sore throat, dyspnea)

  3. Duration of hospitalization [ Time Frame: From day 0 until to the end of hospitalization or date of death for any cause, whichever came first, assessed up to 3 months after Day0 ]
    Total duration of hospitalization

  4. Hospitalization intensive care or reanimation [ Time Frame: From day 0 until to the end of hospitalization or date of death for any cause, whichever came first, assessed up to 3 months after Day0 ]
    Duration of hospitalization in intensive care or reanimation

  5. Duration of mechanical ventilatory assistance [ Time Frame: to the end of mechanical ventilatory assistance if any, assessed up to 3 months after Day0 ]
    Duration of mechanical ventilatory assistance

  6. Percentage of deaths related to SARS-CoV-2 [ Time Frame: Day 28, or end of hospitalization if any (assessed up to 3 months after Day0) ]
    Percentage of deaths related to SARS-CoV-2 infection

  7. AE / SAE in both arms [ Time Frame: Day 28, or end of hospitalization if any (assessed up to 3 months after Day0) ]
    Number of AE / SAE in both arms



Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371952


Contacts
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Contact: Brigitte DRENO 2 40 08 31 18 ext 0033 brigitte.dreno@atlanmed.fr
Contact: Amir KHAMMARI 240 08 32 80 ext 0033 amir.khammaro@chu-nantes.fr

Locations
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France
CHU Avicenne - APHP
Bobigny, France, 93009
Contact: Eve MAUBEC    1 48 95 70 90 ext 0033    eve.maubec@aphp.fr   
CHU Bordeaux
Bordeaux, France, 33075
Contact: Fabrice BONNET    5 56 79 58 23 ext 0033    fabrice.bonnet@chu-bordeaux.fr   
CHU Caen
Caen, France, 14033
Contact: Anne DOMPMARTIN-BLANCHERE    2 31 27 25 10 ext 0033    dompmartin-a@chu-caen.fr   
CHU Dijon
Dijon, France, 21079
Contact: Lionel PIROTH    3 30 29 33 05 ext 0033    lionel.piroth@chu-dijon.fr   
CHU Grenoble
Grenoble, France, 38043
Contact: Marie-Thérèse Leccia    476769320 ext 0033    mtleccia@chu-grenoble.fr   
CHU Nantes
Nantes, France, 44093
Contact: Brigitte DRENO, PUPH    2 40 08 31 18 ext 0033    brigitte.dreno@atlanmed.fr   
Contact: Amir Khammari    2 40 08 32 80 ext 0033    amir.khammari@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04371952    
Other Study ID Numbers: RC20_0191
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents