Protective Effect of Aspirin on COVID-19 Patients (PEAC)
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|ClinicalTrials.gov Identifier: NCT04365309|
Recruitment Status : Enrolling by invitation
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Novel Coronavirus Pneumonia Aspirin Treatment||Drug: Aspirin 100mg||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protective Effect of Aspirin on COVID-19 Patients|
|Actual Study Start Date :||February 10, 2020|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||June 2020|
No Intervention: the NCP standard treatment group
According to the diagnosis and treatment guidelines, the patients were divided into four types: mild, common, severe and critically ill. Then patients with common and severe ill were randomly divided into two groups, respectively, namely the NCP standard treatment group and the NCP aspirin group (aspirin 100 mg/d, oral + combined standard treatment).
Experimental: the NCP aspirin treatment group
According to the diagnosis and treatment guidelines, the patients were divided into four types: mild, common, severe and critically ill. Then patients with common and severe ill were randomly divided into two groups, respectively, namely the NCP standard treatment group and the NCP aspirin group (aspirin 100 mg/d, oral + combined standard treatment). Patients in the NCP aspirin group were given aspirin 100 mg/d orally after admission and aspirin for 14 days after discharge.
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
- clinical recovery time (TTCR) [ Time Frame: not more than 14 days ]TTCR is defined as the study treatment (oral aspirin enteric-coated tablet) began to fever, breathing rate, blood oxygen saturation recovery, and cough relieving for at least 72 hours.
- the time of SARS-CoV2 overcasting [ Time Frame: not more than 37 days ]Time of SARS-CoV2 in upper respiratory tract specimens overcasting detected by RT-PCR.
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): NCT04365309
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Cai Yue||the first affiliated hospital of the Air force medical university|