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COVID19Phase 3DYNAMICNCT04371952

DYNAMIC Study (DoxycYcliNe AMbulatoIre COVID-19)

A Phase 3 study testing Doxycycline in people with COVID19, run by Nantes University Hospital at 6 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 46 years and older
Conditions the study is for
COVID19
What is being tested?
Doxycycline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
6 sitesFrance
Study dates
1 Feb 2021to 1 Feb 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 46 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • CHU Avicenne - APHP

    Bobigny, 93009

  • CHU Bordeaux

    Bordeaux, 33075

  • CHU Caen

    Caen, 14033

  • CHU Dijon

    Dijon, 21079

  • CHU Grenoble

    Grenoble, 38043

  • CHU Nantes

    Nantes, 44093

Other trials in France

About this study

Official title: Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study

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.

Conditions
COVID19
Being tested
Doxycycline, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxycyclineDrug

    comparison of doxycycline 200 mg/day to placebo

  • PlaceboDrug

    Placebo : lactose, 380 mg/gélule

Study groups in NCT04371952
Study groupRoleWhat they receive
Doxycycline 100mgExperimentalDoxycycline capsule containing 2 tablets doxycycline 100mg over-encapsulated. Doxycycline is given at 200 mg once a day and administered per os during 2 weeks
Receives: Drug: Doxycycline
Doxycycline placeboPlacebo comparatorDoxycycline 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients with Clinical Respiratory Aggravation

    Percentage of patients with clinical worsening (SaO2 ≤ 93%) after at least 48 hours of treatment

    Measured: after at least 48 hours of treatment

  2. Percentage of patients hospitalized

    Percentage of patients hospitalized after at least 48 hours of experimental treatment

    Measured: after at least 48 hours of experimental treatment

  3. Percentage of patients requiring ventilatory assistance

    Percentage of patients requiring ventilatory assistance

    Measured: Day 0 to Day 28

Secondary outcomes (7)

  1. Positive SARS-CoV-2 PCR Test

    Number of positive SARS-CoV-2 PCR tests on D-1 / D0 and D7 (+/- 2 days)

    Measured: Day -1 or day 0 AND Day 7

  2. Duration of symptoms

    Duration of symptoms (fever, painful symptoms: headache, sore throat, dyspnea)

    Measured: Day 0 to Day 28

  3. Duration of hospitalization

    Total duration of hospitalization

    Measured: 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

  4. Hospitalization intensive care or reanimation

    Duration of hospitalization in intensive care or reanimation

    Measured: 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

  5. Duration of mechanical ventilatory assistance

    Duration of mechanical ventilatory assistance

    Measured: to the end of mechanical ventilatory assistance if any, assessed up to 3 months after Day0

  6. Percentage of deaths related to SARS-CoV-2

    Percentage of deaths related to SARS-CoV-2 infection

    Measured: Day 28, or end of hospitalization if any (assessed up to 3 months after Day0)

  7. AE / SAE in both arms

    Number of AE / SAE in both arms

    Measured: Day 28, or end of hospitalization if any (assessed up to 3 months after Day0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start1 Feb 2021
  3. Primary completion1 Feb 2021 (estimated)
  4. Study completion1 Feb 2021

Why it stopped: withdrawal due to the evolution of the epidemic, the arrival of vaccination and because the associated centres could no longer commit to the number of inclusions requested

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04371952
Sponsor's protocol ID
RC20_0191
Acronym
DYNAMIC
Status last verified
Apr 2022
First submitted
27 Apr 2020
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Doxycycline in people with COVID19, run by Nantes University Hospital at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients with Clinical Respiratory Aggravation (time frame: after at least 48 hours of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04371952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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