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Status unknownNCT04355429CAPTOCOVIDUpdated Apr 28, 2020

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

A Phase 2 interventional study of captopril 25mg in Pneumonia, Coronavirus Infection and COVID-19, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pneumonia
  • Coronavirus Infection
  • COVID-19
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In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 230 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
230 participants (estimated)

Study arms

  • Experimental
    CAPTOPROL

    Inhalation administration by nebulization

    Drug: captopril 25mg

  • No intervention
    STANDARS CARE

    According to surviving covid-Campaign guidelines

Interventions

  • Drugcaptopril 25mg

    Drug administration

    Also known as: Any

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What researchers measure

Primary outcomes

  1. Efficacy of captopril nebulization addition to standard of care compared to standard of care.

    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

    Time frame: 14 Days

07

Study locations

11 sites
  • CH Victor Dupuy- Argenteuil
    Argenteuil, France
    • Pascale LONGUET, MD · Contact
  • Hôpital Avicenne,
    Bobigny, 93000, France
    • Olivier BOUCHAUD, Pr · Contact
  • Hôpital Avicenne
    Bobigny, 93000, France
  • Hôpital Avicenne
    Bobigny, France
    • Nunes HILARIO, MD · Contact
  • Hôpital Antoine Béclère
    Clamart, France
  • CH de Compiègne-Noyon
    Compiègne, France
    • Anne-Lise LECAPITAINE, MD · Contact
  • Groupe hospitalier Sud Ile de France
    Melun, France
    • Sylvain DIAMANTIS, MD · Contact
  • Hôpital de la Pitié- Salpêtrière
    Paris, France
    • Alexandre BLEIBTREU, MD · Contact
  • Hôpital Tenon
    Paris, France
    • Gilles PIALOUX, Pr · Contact
  • CHRU de Tours, Hôpital Bretonneau
    Tours, France
    • Louis BERNARD, MD · Contact
  • Hôpital de Tours
    Tours, France
    • Laurent PLANTIER, Pr · Contact
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References and documents

Publications

  • Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4. PubMed 32129518 ↗
  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. PubMed 32109013 ↗
  • Li F, Li W, Farzan M, Harrison SC. Structure of SARS coronavirus spike receptor-binding domain complexed with receptor. Science. 2005 Sep 16;309(5742):1864-8. doi: 10.1126/science.1116480. PubMed 16166518 ↗
  • Imai Y, Kuba K, Rao S, Huan Y, Guo F, Guan B, Yang P, Sarao R, Wada T, Leong-Poi H, Crackower MA, Fukamizu A, Hui CC, Hein L, Uhlig S, Slutsky AS, Jiang C, Penninger JM. Angiotensin-converting enzyme 2 protects from severe acute lung failure. Nature. 2005 Jul 7;436(7047):112-6. doi: 10.1038/nature03712. PubMed 16001071 ↗
  • Zhang H, Penninger JM, Li Y, Zhong N, Slutsky AS. Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target. Intensive Care Med. 2020 Apr;46(4):586-590. doi: 10.1007/s00134-020-05985-9. Epub 2020 Mar 3. No abstract available. PubMed 32125455 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04355429
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 21, 2020
Start date
May 5, 2020 (estimated)
Primary completion
Jul 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Apr 28, 2020

Study contacts

Mohammed RAHAOUI, PM
Contact
mohammed.rahaoui@aphp.fr
+33 1 48 95 59 77
Yacine TANDJAOUI-LAMBIOTTE, MD
Contact
yacine.tandjaoui-lambiotte@aphp.fr
Yacine TANDJAOUI-LAMBIOTTE, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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