Efficacy of Captopril in Covid-19 Patients With Severe Acute Respiratory Syndrome (SARS) CoV-2 Pneumonia (CAPTOCOVID)
CAPTOCOVID
Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study
1 other identifier
interventional
230
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2020
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedStudy Start
First participant enrolled
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedApril 28, 2020
April 1, 2020
2 months
April 17, 2020
April 24, 2020
Conditions
Outcome Measures
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
14 Days
Study Arms (2)
CAPTOPROL
EXPERIMENTALInhalation administration by nebulization
STANDARS CARE
NO INTERVENTIONAccording to surviving covid-Campaign guidelines
Interventions
Eligibility Criteria
You may qualify if:
- Hospitalization for acute respiratory failure requiring oxygen administration ≥3L/mn
- Age \> 18 years or older
- Presence of pneumonia
- PCR SARS-CoV-2 positive in any biological sample in the last 7 days
- Patient affiliated to social security regime
- Written informed consent provided by the patient or alternatively by next-of-kin, or in emergency situations, prior to any protocol-specific procedures
You may not qualify if:
- Decision of withholding invasive mechanical ventilation
- Shock requiring vasopressor infusion
- Co-infection with another respiratory pathogen which could be responsible of pneumonia
- Hypersensitivity to captopril, to any other angiotensin converting enzyme inhibitor or any of the excipients of the specialty used
- History of angio-oedema
- History of ACE-inhibitor allergy
- 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.
- Patient who is currently enrolled in other investigational study;
- Persons deprived of their liberty by judicial or administrative decision,
- Persons under legal protection/safeguard of justice,
- Patients under duress psychiatric care,
- Persons admitted to a health or social institution
- Patient on state medical aid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
CH Victor Dupuy- Argenteuil
Argenteuil, France
Hôpital Avicenne,
Bobigny, 93000, France
Hôpital Avicenne
Bobigny, 93000, France
Hôpital Avicenne
Bobigny, France
Hôpital Antoine Béclère
Clamart, France
CH de Compiègne-Noyon
Compiègne, France
Groupe hospitalier Sud Ile de France
Melun, France
Hôpital de la Pitié- Salpêtrière
Paris, France
Hôpital Tenon
Paris, France
CHRU de Tours, Hôpital Bretonneau
Tours, France
Hôpital de Tours
Tours, France
Related Publications (5)
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.
PMID: 32129518BACKGROUNDGuan 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.
PMID: 32109013RESULTLi 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.
PMID: 16166518RESULTImai 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.
PMID: 16001071RESULTZhang 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.
PMID: 32125455RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yacine TANDJAOUI-LAMBIOTTE, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 21, 2020
Study Start
May 5, 2020
Primary Completion
July 1, 2020
Study Completion
August 1, 2020
Last Updated
April 28, 2020
Record last verified: 2020-04