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

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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

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE May 1, 2020
Last Update Posted Date May 18, 2020
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • 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
  • 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
  • Percentage of patients requiring ventilatory assistance [ Time Frame: Day 0 to Day 28 ]
    Percentage of patients requiring ventilatory assistance
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • Clinical worsening SaO2 [ Time Frame: after at least 48 hours of treatment ]
    Percentage of patients with clinical worsening (SaO2 ≤ 93%) after at least 48 hours of treatment
  • Patients hospitalized [ Time Frame: after at least 48 hours of experimental treatment ]
    Percentage of patients hospitalized after at least 48 hours of experimental treatment
  • Ventilatory assistance [ Time Frame: Day 0 to Day 28 ]
    Percentage of patients requiring ventilatory assistance
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • 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)
  • Duration of symptoms [ Time Frame: Day 0 to Day 28 ]
    Duration of symptoms (fever, painful symptoms: headache, sore throat, dyspnea)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • 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)
  • Duration of symptoms [ Time Frame: Day 0 to Day 28 ]
    Duration of symptoms (fever, painful symptoms: headache, sore throat, dyspnea)
  • 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
  • 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 ]
    Number and duration of hospitalization in intensive care or reanimation
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DYNAMIC Study (DoxycYcliNe AMbulatoIre COVID-19)
Official Title  ICMJE Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE COVID19
Intervention  ICMJE
  • Drug: Doxycycline
    comparison of doxycycline 200 mg/day to placebo
  • Drug: Placebo
    Placebo : lactose, 380 mg/gélule
Study Arms  ICMJE
  • 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
    Intervention: Drug: Doxycycline
  • 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2020)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 46 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04371952
Other Study ID Numbers  ICMJE RC20_0191
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP