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COVID-19Phase 2DICOVNCT05563168

Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia

A Phase 2 study of COVID-19, run by Hospices Civils de Lyon at 21 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

SARS-CoV-2 infection is responsible for hypoxemic pneumonia, which is sometimes serious and associated with excess mortality. To date, with the exception of dexamethasone, which has shown clinical efficacy by reducing the mortality of infected patients, no other therapeutic strategy has demonstrated a curative… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
21 sitesFrance
Study dates
Apr 2023to Dec 2024
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 18 or over
  • SARS-CoV-2 infection proven by RT-PCR on a nasopharyngeal sample within 72 hours prior to inclusion in the study
  • Onset of symptoms of viral infection ≤ 7 days
  • Hospitalization required due to hypoxemia (air saturation < 94% at rest)
  • Presence of radiological pneumopathy (chest X-ray or non-enhanced thoracic CT)
  • Patient affiliated to a social security scheme.
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  • Patient capable of giving free, informed and written consent.
  • Patient with a history of SARS-CoV-2 infection may participate in the study, but this infection must not have occurred within the 3 months prior to his current hospitalization.
  • Patient who has been vaccinated against SARS-CoV-2 can participate in the study (regardless of the number of doses)
  • Patient not eligible for specific anti-COVID treatment authorized in France (MA or early access) and not part of the standard of care at the time of the study
  • Female patient of childbearing age using effective contraception during study participation, the same applies to partners of childbearing age of male patients. Male patients must use condoms.

Who cannot join

  • Need for hospitalization in intensive care unit at inclusion
  • Patient with cognitive impairment, at the discretion of the investigator
  • Pregnant woman (positive urine pregnancy test on inclusion) or breastfeeding
  • Participation in another interventional study or being in the exclusion period from a previous study
  • Patient on diltiazem therapy
  • Contraindication to diltiazem
Show all 19Show fewer
  • Hypersensitivity to diltiazem or to any of the excipients
  • Unaided sinus dysfunction
  • Unaided 2nd and 3rd degree atrioventricular blocks
  • Left ventricular failure with pulmonary stasis (cardiogenic edema)
  • Severe bradycardia (≤ 40 beats per minute)
  • In combination with: dantrolene infusion, pimozide, dihydroergotamine, ergotamine, nifedipine, ivabradine, beta blockers, antiarrhythmics, esmolol, fingolimod.
  • Patient with renal, hepatic or cardiac insufficiency (at the discretion of the investigator)
  • Hypersensitivity to mannitol
  • Use of anti-COVID medications other than those offered in routine testing and care.
  • Presence of hemodynamic instability, systolic blood pressure < 100 mmHg, presence of multi-visceral failure
  • Prior respiratory pathology requiring oxygen therapy at the long-term and/or non-invasive ventilation
  • Immunocompromised patients (organ transplant, allograft, under chemotherapy, under Rituximab or a history of Rituximab), for any other situation seek the advice of the coordinating investigator
  • Patient under guardianship, curatorship or safeguard of justice

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • respiratory department Amiens Hospital

    Amiens, 80054

  • Service de Maladies infectieuses et tropicales

    Amiens, 80054

  • Département de Pneumologie, CHU Angers

    Angers, 49100

  • Service de Pneumologie, CHU Besançon

    Besançon, 25030

  • Service de pneumologie Hôpital Haut-Leveque

    Bordeaux, 33604

  • Service de Pneumologie CHU Gabriel Montpied

    Clermont-Ferrand, 63000

  • Service des Maladies Infectieuses et Tropicales

    Fort-de-France, 97261

  • Maladies infectieuses et Tropicales CHU Grenoble Rhône-Alpes

    Grenoble, 38043

  • Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon

    Lyon, 69004

  • Médecine Interne, Hôpital de la Croix- Rousse, HOSPICES CIVILS DE LYON

    Lyon, 69004

  • Clinique des bronches, de l'allergie et du sommeil Hôpital Nord

    Marseille, 13015

  • de Pneumologie Groupe Hospitalier du Havre Hôpital

    Montivilliers, 76290

  • Pulmonology department CHU Montpellier

    Montpellier, 34295

  • Service Pneumologie, Hôpital BICHAT

    Paris, 75018

  • Service de Pneumologie, GHU APHP-Sorbonne Université, site Pitié Salpêtrière

    Paris, 75651

  • Service de pneumologie, CHLS, Hospices Civils de Lyon

    Pierre-Bénite, 69310

  • Médecine interne, CHMS, Hospices Civils de Lyon

    Pierre-Bénite

  • Department of Pulmonology-Thoracic Oncology, University Hospital of SaintEtienne

    Saint-Etienne, 42055

  • Service de pneumologie, CHRU Strasbourg

    Strasbourg, 67000

  • Clinique des Voies Respiratoires Hôpital Larrey

    Toulouse, 31059

  • Service des Maladies Infectieuses et du Voyageur Hôpital Gustave Dron

    Tourcoing, 59208

Other trials in France

About this study

Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia - A Phase IIB, Proof of Concept Study

SARS-CoV-2 infection is responsible for hypoxemic pneumonia, which is sometimes serious and associated with excess mortality. To date, with the exception of dexamethasone, which has shown clinical efficacy by reducing the mortality of infected patients, no other therapeutic strategy has demonstrated a curative clinical benefit, particularly in the initial stages facilitating viral eviction. .

Based on the mechanism of action and the available data, diltiazem, administered in the first days post-infection, could facilitate viral eradication in these patients through the stimulation of the innate immune response of cells of the infected respiratory epithelium, actor in the fight against SARS-CoV-2.

In this context, the investigators propose the DICOV trial, to demonstrate the ability of diltiazem to reduce the viral load more rapidly, in patients hospitalized for COVID-19 hypoxemic pneumonia.

Conditions
COVID-19
Being tested
DILTIAZEM TEVA 60 mg or placebo
Keywords
Pneumonia, Viral, Diltiazem
Medical subject headings
COVID-19, Pneumonia, Viral

What participants receive

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

  • DILTIAZEM TEVA 60 mg or placeboDrug

    DILTIAZEM TEVA 60 mg 3 times a day during 7 days + standard of care Or placebo 3 times a day during 7 days + standard of care.

Study groups in NCT05563168
Study groupRoleWhat they receive
Standard Of Care (SOC) + diltiazemExperimentalPatients will receive the standard of care at the time of their inclusion in the trial and will also receive diltiazem (60mg 3 times a day) for 7 days.
Receives: Drug: DILTIAZEM TEVA 60 mg or placebo
SOC + placeboPlacebo comparatorPatients will receive the standard of care at the time of their inclusion in the trial and will also receive a diltiazem placebo (3 times a day) for 7 days
Receives: Drug: DILTIAZEM TEVA 60 mg or placebo

What is being measured

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

  1. SARS-CoV-2 viral load decrease between D1 and D7

    Dosage of the standardized SARS-CoV-2 viral load on nasopharyngeal samples on day 1 and day 7 after treatment initiation.

    Measured: At day 1 and day 7 post treatment initiation.

Secondary outcomes (14)

  1. Time to clinical improvement

    Time to clinical improvement (in days), defined as the time from randomization to an improvement of at least 2 points on a 7-point ordinal scale

    Measured: Within 28 days post-randomization

  2. Overall survival

    Percentage of patients who died between D1 and D28 of the start of treatment

    Measured: at day 28

  3. SARS-CoV-2 viral load kinetics

    Kinetics of viral load decrease by dosage of the normalized SARS-CoV-2 viral load on nasopharyngeal samples

    Measured: Day 1, day 7, day 15, day 21 and day 28

  4. proportion of patients who are potential transfer candidates in intensive care

    Percentage of patients candidates for transfer to intensive care at Day 15 of the start of treatment

    Measured: At Day 15

  5. Tolerance of the study treatment

    Occurrence of adverse events, severe adverse events and premature discontinuation of study treatment

    Measured: Within 28 days after treatment initiation

  6. Duration of oxygen therapy

    Number of days the patient was put on oxygen therapy

    Measured: Within 28 days after treatment initiation

  7. Proportion of patients requiring assisted or non-invasive ventilation

    Percentage of patients requiring assisted or non-invasive ventilation

    Measured: Within 28 days after treatment initiation

  8. Duration of assisted or non-invasive ventilation

    Number of days the patient was put on assisted or non-invasive ventilation

    Measured: Within 28 days after treatment initiation

  9. Duration of hospitalization in intensive care unit

    Number of days spent in intensive care

    Measured: At day 28.

  10. Duration of hospitalization in intensive care unit

    Number of days spent in intensive care. For patients still in intensive care on D28 this information will be collected on D90

    Measured: At day 90

  11. Hospital length of stay

    Number of days spent in hospital

    Measured: At day 28.

  12. Hospital length of stay

    Number of days spent in hospital. For patients still in intensive care on D28 this information will be collected on D90

    Measured: At day 90

  13. Flow rate of oxygen used

    Maximum oxygen rate used

    Measured: Within 28 days after treatment initiation

  14. Extension of viral pneumonitis

    Difference in extension of viral pneumonitis on comparative analysis scans performed at D1 and D28

    Measured: Day 1, day 28

Timeline

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

  1. First posted3 Oct 2022
  2. Study startApr 2023 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: the epidemiological situation has changed considerably.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563168
Sponsor's protocol ID
69HCL21_0855
Other IDs
2021-004160-94
Acronym
DICOV
Status last verified
May 2023
First submitted
30 Sep 2022
Last updated
26 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of COVID-19, run by Hospices Civils de Lyon at 21 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 11 inclusion and 19 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

SARS-CoV-2 viral load decrease between D1 and D7 (time frame: At day 1 and day 7 post treatment initiation.). 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 NCT05563168.

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 26 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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