Efficacy of Captopril in Covid-19 Patients With Severe Acute Respiratory Syndrome (SARS) CoV-2 Pneumonia (CAPTOCOVID) (CAPTOCOVID)

April 24, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study

Captopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Coronavirus Disease 2019 (COVID-19) is due to SARS-CoV-2 infection. The main cause of death is refractory acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 pneumonia. The SARS-CoV-2 may have specific virulence factors to achieve mortality rates around 3%. As the SARS-CoV, virus responsible of the Severe Acute Respiratory Syndrome in 2003 (which mortality was around 10%), the SARS-CoV-2 uses angiotensin-converting enzyme 2 (ACE2) as the receptor binding domain for its spike protein making ACE2 the gateway in the alveolar epithelial cells1. Angiotensin-converting enzyme (ACE) and ACE2 are known to be present in respiratory epithelium and to have antagonist physiological functions. ACE2 has an anti-inflammatory, anti-fibrosing role, anti-oxydant and vasodilatator activity, while ACE has the opposite characteristics. These two enzymes have a negative control on each other, one inhibiting the other. Demonstrated that SARS-CoV is responsible of a downregulation of ACE2 functions by using ACE2 as cell receptor2. While ACE2 is downregulated, ACE activity increase leading to more alveolar damage and acute respiratory failure.

ACE inhibitors are common drugs used to treat hypertension worldwide. Using an ACE inhibitor as treatment against SARS-CoV-2 could be counter-intuitive because increasing ACE2 expression would open the cellular gate to the virus3,4. However, ACE2 was described as protecting lung injury2, leading Recombinant Human ACE2 as a perspective for SARS-CoV-2 treatment.

A simple way to increase ACE2 in patients with SARS-CoV-2 pneumonia could be an inhalation of ACE inhibitor.

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Argenteuil, France
        • CH Victor Dupuy- Argenteuil
        • Contact:
          • Pascale LONGUET, MD
      • Bobigny, France, 93000
      • Bobigny, France
        • Hôpital Avicenne
        • Contact:
          • Nunes HILARIO, MD
      • Bobigny, France, 93000
        • Hôpital Avicenne,
        • Contact:
          • Olivier BOUCHAUD, Pr
      • Clamart, France
        • Hôpital Antoine Béclère
      • Compiègne, France
        • CH de Compiègne-Noyon
      • Melun, France
        • Groupe Hospitalier Sud Ile de France
        • Contact:
          • Sylvain DIAMANTIS, MD
      • Paris, France
        • Hopital Tenon
        • Contact:
          • Gilles PIALOUX, Pr
      • Paris, France
        • Hôpital de la Pitié- Salpêtrière
        • Contact:
          • Alexandre BLEIBTREU, MD
      • Tours, France
        • CHRU de Tours, Hôpital Bretonneau
        • Contact:
          • Louis BERNARD, MD
      • Tours, France
        • Hôpital de Tours
        • Contact:
          • Laurent PLANTIER, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Hospitalization for acute respiratory failure requiring oxygen administration ≥3L/mn
  2. Age > 18 years or older
  3. Presence of pneumonia
  4. PCR SARS-CoV-2 positive in any biological sample in the last 7 days
  5. Patient affiliated to social security regime
  6. Written informed consent provided by the patient or alternatively by next-of-kin, or in emergency situations, prior to any protocol-specific procedures

Exclusion Criteria:

  1. Decision of withholding invasive mechanical ventilation
  2. Shock requiring vasopressor infusion
  3. Co-infection with another respiratory pathogen which could be responsible of pneumonia
  4. Hypersensitivity to captopril, to any other angiotensin converting enzyme inhibitor or any of the excipients of the specialty used
  5. History of angio-oedema
  6. History of ACE-inhibitor allergy
  7. Known pregnancy or current lactation: Female subject of childbearing potential should have a negative serum pregnancy test prior to receiving the first dose of study medication.
  8. Patient who is currently enrolled in other investigational study;
  9. Persons deprived of their liberty by judicial or administrative decision,
  10. Persons under legal protection/safeguard of justice,
  11. Patients under duress psychiatric care,
  12. Persons admitted to a health or social institution
  13. Patient on state medical aid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CAPTOPROL
Inhalation administration by nebulization
Drug: captopril 25mg
Drug administration
Other Names:
  • Any
NO_INTERVENTION: STANDARS CARE
According to surviving covid-Campaign guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of captopril nebulization addition to standard of care compared to standard of care.
Time Frame: 14 Days
To assess determine the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival
14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Yacine TANDJAOUI-LAMBIOTTE, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 5, 2020

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (ACTUAL)

April 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200410

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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