Protective Effect of Aspirin on COVID-19 Patients (PEAC)
![]() |
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: NCT04365309 |
Recruitment Status : Unknown
Verified March 2020 by Xijing Hospital.
Recruitment status was: Enrolling by invitation
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 24, 2020 | ||||
First Posted Date ICMJE | April 28, 2020 | ||||
Last Update Posted Date | April 28, 2020 | ||||
Actual Study Start Date ICMJE | February 10, 2020 | ||||
Estimated Primary Completion Date | April 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Protective Effect of Aspirin on COVID-19 Patients | ||||
Official Title ICMJE | Protective Effect of Aspirin on COVID-19 Patients | ||||
Brief Summary | COVID-19 has a high infection rate and mortality, and serious complications such as heart injury cannot be ignored. Cardiac dysfunction occurred in COVID-19 patients, but the law and mechanism of cardiac dysfunction remains unclear. The occurrence of progressive inflammatory factor storm and coagulation dysfunction in severe and fatal cases of NCP points out a new direction for reducing the incidence of severe and critically ill patients, shortening the length of duration in severe and critically ill patients and reducing the incidence of complications of cardiovascular diseases. Aspirin has the triple effects of inhibiting virus replication, anticoagulant and anti-inflammatory, but it has not received attention in the treatment and prevention of NCP. Although Aspirin is not commonly used in the guidelines for the treatment of NCP, it was widely used in the treatment and prevention of a variety of human diseases after its first synthesis in 1898. Subsequently, aspirin has been confirmed to have antiviral effect on multiple levels. Moreover, one study has confirmed that aspirin can inhibit virus replication by inhibiting prostaglandin E2 (PGE2) in macrophages and upregulation of type I interferon production. Subsequently, pharmacological studies have found that aspirin as an anti-inflammatory and analgesic drug by inhibiting cox-oxidase (COX). Under certain conditions, the platelet is the main contributor of innate immune response, studies have found that in the lung injury model in dynamic neutrophil and platelet aggregation. In summary, the early use of aspirin in covid-19 patients, which has the effects of inhibiting virus replication, anti-platelet aggregation, anti-inflammatory and anti-lung injury, is expected to reduce the incidence of severe and critical patients, shorten the length of hospital duration and reduce the incidence of cardiovascular complications. |
||||
Detailed Description |
Although Aspirin is not commonly used in the guidelines for the treatment of NCP, it was widely used in the treatment and prevention of a variety of human diseases after its first synthesis in 1898. First, aspirin was first synthesized in 1898 and has been widely used in the treatment and prevention of many human diseases. Subsequently, aspirin has been confirmed to have antiviral effect on multiple levels [4]. However, one study published in Immunity in 2014, has confirmed that aspirin can inhibit virus replication by inhibiting prostaglandin E2 (PGE2) in macrophages and upregulation of type I interferon production [5]. Subsequently, pharmacological studies have found that aspirin as an anti-inflammatory and analgesic drug by inhibiting cox-oxidase (COX). Because it was first discovered by inhibiting the activity of cox-oxidase (COX), inhibiting the synthesis of prostaglandin, inhibiting the aggregation of white blood cells, reducing the formation of bradykinin, inhibiting the aggregation of platelets and so on. Under certain conditions, the platelet is the main contributor of innate immune response, studies have found that in the lung injury model in dynamic neutrophil and platelet aggregation, and aspirin by promoting lipid oxygen element (Lipoxin, 15 - epi - LXA4), and reduce the number of neutrophils and inhibition of neutrophil and platelet aggregation, in inhibiting the inflammatory response and lung injury has a key role in the model [6]. Compared with other NSAIDS, low-dose aspirin (less than 100 mg/ day) is highly safe for long-term use and has fewer adverse events such as gastrointestinal bleeding. And a recent meta-analysis published in JAMA Intern Med found that in the treatment of DVP in patients with total hip or total knee replacement, The anticoagulant effect and side effects of aspirin were not significantly different from other anticoagulants (dalteparin sodium, Rivaroxaban, enoxaparin sodium, Warfarin sodium, Dihydroergotamine mesylate -- heparin sodium) [7]. The dosages of aspirin used in the reviewed literature ranged from 81 mg/d to 325 mg/d, but the majority of the literature used 100 mg/d was consistent with our current clinical dosages. A number of studies have found that aspirin also has other extensive effects, such as anti-tumor [8], regulation of gestational hypertension [9], prevention of preterm birth [10]. In summary, there is still a lack of effective drugs for the treatment of covid-19, and the regularity and characteristics of myocardial injury in patients are unclear. In addition, prevention and treatment strategies for myocardial injury in COVID-19 patients have not been put on the agenda. The early use of aspirin in covid-19 patients, which also has the effects of inhibiting virus replication, anti-platelet aggregation, anti-inflammatory and anti-lung injury, is expected to reduce the incidence of severe and critical patients, shorten the length of hospital duration and reduce the incidence of cardiovascular complications. This project is based on important clinical issues, combined with the latest international research progress, to explore the early use of aspirin enteric-coated tablets in covid-19 patients on the treatment of covid-19 and the prevention of cardiovascular complications, to contribute to the prevention and control of the epidemic, undoubtedly has important theoretical and application value. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Drug: Aspirin 100mg
on the bases of standard treatment for the COVID-19, low-dose aspirin (100 mg/ day), orally,is added to.
Other Name: Oxygen therapy, antiviral treatment and other support treatments
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
128 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2020 | ||||
Estimated Primary Completion Date | April 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04365309 | ||||
Other Study ID Numbers ICMJE | Xi jingH | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Xijing Hospital | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Xijing Hospital | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Xijing Hospital | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |