Protective Effect of Aspirin on COVID-19 Patients

• Status: Enrolling by invitation
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Aspirin

Criteria

Inclusion Criteria:

1. The patient volunteered to participate in the study, approved the aspirin treatment, and was willing to randomly accept one of the aspirin treatment regimens, and provided written informed consent,

2. Subject is required to meet one of the following criteria for confirmation of a novel coronavirus infection with pneumonia: 1.The detection of novel coronavirus nucleic acid is positive in respiratory or blood specimens by Real-time -PCR, 2. Virus gene sequencing of respiratory or blood specimen is highly homologous with known novel coronavirus,

3. Chest image confirmed pulmonary involvement;

4. fever: ≥36.7℃ under the armpit, ≥38.0℃ in the oral cavity or ≥38.6℃ in the rectum and eardrum; • respiratory frequency ≥24 times/min or at least one cough;

5. Onset time ≤14 days;

6. Agree not to participate in another study until completion of the 14-day study; If you need to withdraw from this study;

7. The subjects had not taken aspirin for nearly one month prior to the screening period.

8. Can follow the study or follow up procedure. -

Exclusion Criteria:

1. Women who have recently been pregnant or breast-feeding.

2. Having a history of active gastrointestinal bleeding in the past 3 months.

3. Blood routine examination showed that the platelet count was < 30×109/L.

4. Patients with coagulation disorders.

5. Unable to understand the potential risks and benefits of the study, and unable to follow up the evaluation as required.

6. Having no capacity for civil conduct.

7. A history of drug or alcohol abuse.

8. Allergic to aspirin.

9. Influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human partial lung virus, mycoplasma pneumoniae, chlamydia pneumonia, bacterial pneumonia, organized pneumonia, etc.

10. Patients with cardiac stent placement (< 1 year).

11. Any more complex medical problems that may interfere with research behavior or lead to increased risk, such as malignant tumors, blood diseases, liver diseases, AIDS, viral hepatitis, etc.