We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355429
Recruitment Status : Unknown
Verified April 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Coronavirus Infection COVID-19 Drug: captopril 25mg Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study
Estimated Study Start Date : May 5, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Captopril

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CAPTOPROL
Inhalation administration by nebulization
 Drug: captopril 25mg
Drug administration
Other Name: Any
No Intervention: STANDARS CARE
According to surviving covid-Campaign guidelines


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04355429


Contacts
Layout table for location contacts
Contact: Mohammed RAHAOUI, PM +33 1 48 95 59 77 mohammed.rahaoui@aphp.fr
Contact: Yacine TANDJAOUI-LAMBIOTTE, MD yacine.tandjaoui-lambiotte@aphp.fr

Locations
Layout table for location information
France
CH Victor Dupuy- Argenteuil
Argenteuil, France
Contact: Pascale LONGUET, MD         
Hôpital Avicenne,
Bobigny, France, 93000
Contact: Olivier BOUCHAUD, Pr         
Hôpital Avicenne
Bobigny, France, 93000
Contact: Yacine TANDJAOUI-LAMBIOTTE, MD       yacine.tandjaoui-lambiotte@aphp.fr   
Hôpital Avicenne
Bobigny, France
Contact: Nunes HILARIO, MD         
Hôpital Antoine Béclère
Clamart, France
CH de Compiègne-Noyon
Compiègne, France
Contact: Anne-Lise LECAPITAINE, MD         
Groupe hospitalier Sud Ile de France
Melun, France
Contact: Sylvain DIAMANTIS, MD         
Hôpital de la Pitié- Salpêtrière
Paris, France
Contact: Alexandre BLEIBTREU, MD         
Hôpital Tenon
Paris, France
Contact: Gilles PIALOUX, Pr         
CHRU de Tours, Hôpital Bretonneau
Tours, France
Contact: Louis BERNARD, MD         
Hôpital de Tours
Tours, France
Contact: Laurent PLANTIER, Pr         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Yacine TANDJAOUI-LAMBIOTTE, MD Assistance Publique - Hôpitaux de Paris
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04355429    
Other Study ID Numbers: APHP200410
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Pneumonia
Coronavirus Infections
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Captopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents